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Govt.

of India
Department of AYUSH
Ministry of Health and Family Welfare
Pharmacopoeial Laboratory for Indian Medicines
GHAZIABAD

LEGAL STATUS OF AYURVEDIC,
SIDDHA & UNANI MEDICINES

Dr. D.R. Lohar, M.Sc., Ph.D.
Director

Government of India
Department of AYUSH
Ministry of Health & Family Welfare
PHARMACOPOEIAL LABORATORY FOR INDIAN MEDICINES
GHAZIABAD

DR. Siddha and Unani medicines in relation to pharmacopoeia and legal provisions etc. D. Unani Pharmacopoeia of India and Drugs & Cosmetics Act may be consulted. the Ayur vedic. legal provisions relating to quality control and the penal actions at one place so that it may become handy for manufacturers. For legal purposes or any controversy. the Ayurvedic Pharmacopoeia of India. pharmacies. Standards for Ayurvedic. UPI and Drugs & Cosmetics Act. The need of compilation of different Ayurvedic. import of Ayurvedic. Siddha and Unani drugs. Siddha and Unani medicines.R. This laboratory has made an endeavor to compile such information. Siddha and Unani medicines have been released in Ayurvedic Pharmacopoeia of India and Unani Pharmacopoeia of India which should be consulted for the details. PREFACE D uring the past five decades. Siddha and Unani Pharmaceutical Industries have provided a vast range of drugs for human use and have evolved an increasing sophistication in the production of medicaments. Siddha and Unani manufacturing processes. marker compounds or materials for research or self use) have also been given for related products. Information about manufacture. and the persons involved in quality control of Ayurvedic. There has been appreciable acceptance with considerable improvement in quality. related provisions and proforma for import of medicines (which are directly or indirectly related to ASU medicines. Besides the Legal provisions of ASU medicines. Good Manufacturing Practices and the related portion of Drugs & Cosmetics Act to create general awareness among the persons who are involved in this professions or who are keen in this profession was long felt. The primary responsibility for assuring quality control of medicines is that of manufacturer and it is hoped that this booklet will help them to achieve this target. Manufacture and quality control of Ayurvedic. Attempts have been made to bring various aspects of manufacture of Ayurvedic. quality control measures. sale. LOHAR . Siddha and Unani Medicines come under the purview of Drugs & Cosmetics Act. The information given in this document is compilation of related portions from API. are scattered. Regulatory and recommendatory standards for most of them have been released.

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Chapter IV – Powers & Procedure of Inspectors 16 7. DCC 12 5. Preface 3 3. Packing & Labelling of ASU Drugs 41 (Part XVII – Rule 161-161A) 12. Manufacture for Sale or for Distribution of ASU Medicine 32 (Part XVI – Rule 151-160) 10. Chapter II – Drugs Technical Advisory Board. Approval of Institutions for Carrying out Tests on ASU Drugs 36 (Part XVI(A) – Rule 160A-J) 11. Chapter V – Miscellaneous 27 The First Schedule 30 Drugs & Cosmetics Rule 1945 9. Chapter III – Import of Drugs and Cosmetics 13 6. 1. INDEX S. Government Analyst & Inspectors for ASU Drugs (Part-XVIII) 43 Rule 162 – Duties of Inspectors 43 162A – Qualifications of State Licensing Authorities 43 163 – Dispatch of Samples to Government Analyst & CDL-PLIM.No. Siddha and Unani Drugs) 20 33EED – Powers of Central Govt. Detailed Contents Page No. Chapter IVA – Provision Relating to (Ayurveda. Chapter I – Introductory 9 4. Foreword 1 2. to Prohibit Manufacture 23 33N – Power of Central Govt. to Make Rules 25 8. Ghaziabad 43 163E – Report of Result of Test or Analysis 44 163F – Fees 45 .

Part I 111 23. List of Drugs covered in API Vol. 164 – Method of Test or Analysis 45 165 – Qualification of Government Analysts 45 166 – Duties of Government Analysts 46 167 – Qualifications of Inspector 47 13. Standards of ASU Drugs (Part XIX – Rule 168) 48 14. List of Government Approved Pvt. Schedule T – Good Manufacturing Practices 76 19. List of NABL Accredited Laboratories 120 . Addresses of State Drugs Controllers of ASU 113 24. Drugs Testing Laboratories 118 26. I. Schedule E(I) – List of Poisonous Substances 72 17.6 LEGAL STATUS OF AYURVEDIC. Department of Ayush 89 20. List of Drugs covered in UPI Vol. Schedule A – Forms 51 15. SIDDHA AND UNANI MEDICINES S. I. Detailed Contents Page No. Drugs & Magic Remedies Act 93 21. Orders Issued by Government of India.No. Part I to V 101 22. Schedule FF 74 18. List of State Government Drugs Testing Laboratories 116 25. Schedule B – Fee for Test or Analysis 71 16.

SIDDHA AND UNANI DRUGS DRUGS AND COSMETICS ACT.LEGAL STATUS OF AYURVEDIC. 1940 .

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as the Central Government beautifying. Short title. treatment.– prevention of [disease or disorder (i) This Act may be called the Drugs in human beings or animals. but prescribed in the authoritative books Chapter III shall take effect only of [Ayurvedic. appoint in constituted under Section 33-C. Chapter III shall sprinkled or sprayed on. the human body or any Cosmetics (Amendment) Act. INTRODUCTORY CHAPTER I 1. Siddha and Unani from such date as the Central Tibb systems of medicine. manufactured exclusively in (ii) It extends to the whole of India.– of. 1972 (19 par t thereof for cleansing of 1972). by like notification. accordance with the formulae (iii) It shall come into force at once. 1940. subject or context. extent and diagnosis. or take effect only from such date after the introduced into. 1930 (2 i) all medicines for internal or of 1930). treatment. promotion may. appointed in this behalf. and not in derogation [(b) “drug includes.– The provision of this Act shall be in addition to. Siddha and Unani such date as the State Government Drugs Technical Advisory Board] may. and this behalf: [(aaa) “cosmetic” means any article Provided that in relation to the State intended to be rubbed.] the Official Gazette. appearance. Application of other laws not cosmetic. of Jammu and Kashmir. and includes any article intended for use as a component of 2. or altering the Gazette. specified Government may.– mitigation or prevention of any disease or disorder in human (a) “Ayuvedic. Siddha or Unani Drugs” beings or animals. by notification in in the First Schedule. by notification in the Official attractiveness. appoint in this (aa) “the Board” means.– in relation to behalf. [and Cosmetics] Act.] barred. or animals and all substance Definitions:– In this Act. and Chapter IV-A shall take Ayurvedic. poured. mitigation or commencement. including includes all medicines intended for preparations applied on human internal or external use for or in the body for the purpose of . the Dangerous Drugs Act. and any other law for the time external use of human beings being in force. effect in a particular State only from the [Ayurvedic. or other wise commencement of the Drugs and applied to. Unless intended to be used for or in there is anything repugnant in the the diagnosis. Siddha or Unani drug.

Siddha or Unani Tibb systems including empty gelatin capsules of medicine specified in the First and Schedule. 1940. altering. mitigation included in the authoritative books as or prevention of disease or specified in clause (a). finishing. 1975 Mah LJ 455 [Ayurvedic. af ter i) It is not necessary that the article consultation with the Board. as may be specified rules made under this Act. a Government Analyst appointed then also it will be a cosmetic within by the Central Government or a State the meaning of the Drugs and Government under Section 33-F. and Cosmetics Act. inclusive one. breaking up or otherwise use of human beings or animals or treating or adopting any drug [or any substances intended to be used cosmetic] with a view to its [sale or for or in the diagnosis. If it is applied to a part of the body “Government Analyst” means. treatment.] human body or intended to be “to impor t” means with its used for the destruction of grammetical variations and cognate [vermin] or insects which cause expressions means to bring into [India] disease in human beings or “Patent or proprietary medicine” animals. Zahid Hussain. or the packing of any drug or ii) Such substances (other than cosmetic] in the ordinary course of retail food) intended to affect the business. State of Bombay v. distribution] but does not include the mitigation or prevention of diseases . and “to manufacture” shall be structure or any function of the construed accordingly. SIDDHA AND UNANI MEDICINES repelling insects like compounding or dispensing [of any mosquitoes. as may be specified means. State of Bombay “Inspector” means. Siddha or Unani] attractiveness or alters appearance drug. and 1975 Mah LJ 455 “Manufacture” in relation to any drug [or cosmetic] includes any process i) The definition of ‘drug’ is an or part of a process for making. It includes all ornamenting. but does not include a iv) such devices intended for medicine which is administered by internal or external use in the parenteral route and also a formulation diagnosis. an ii) ‘Gandh’ and nail polish’ are Inspector appointed by the Central ‘cosmetics’ within the meaning of Government or a State Government the Act. Siddha from time to time by the Central or Unani Tibb systems of medicine all Government by notification in formulations containing only such the Official Gazette.] drug. treatment. packing. under Seciton 33-G.– in relation to v.– In relation to Ayurvedic.10 LEGAL STATUS OF AYURVEDIC. medicines for external or internal labelling. from time to timeby the central Government by notification in COMMENTS the official Gazette. should be applied to the whole body. disorder in human beings or “prescribed” means prescribed by animals. Siddha or Unani] drug. Zahid Hussain. ingredients mentioned in the formulae iii) all substances intended for use described in the authoritative books of as components of a drug Ayurveda.– in and if it beautifies or promotes relation to [Ayurvedic.

Sundarka v. functionary not in existence in the State of Jammu and Kashmir. shall. Sheth v. Maharashtra.– Any substance specified injection into human body is ‘drug’ as poisonous by rule made under R. in relation to that State. i) Water meant to be used for 4.– Any reference in this Act to any law which . Chimanlal J. State of West Bengal.Construction of references to III or Chapter IV [or Chapter IVA] as any law not in force or any the case may be. is not in force. State of corresponding functionary in existence. Presumption as to poisonous dissolving other medicines for substances. ii) The appropriate meaning of the be construed as a reference to the expression ‘substances’ in the section corresponding law in force. LEGAL STATUS OF AYURVEDIC.C. or to the is things. AIR 1963 SC 665 in that State. (1973) 1 cwr in existence in the State of Jammu and 368. 1971 Chapter III or Chapter IV [or Chapter Cr LJ 1369 77 CWN 437 IVA] shall be deemed to be a poisonous substance for the purpose of Chapter 3A. State of Orissa. SIDDHA AND UNANI MEDICINES 11 in human beings or animals. Kashmir. or any functionary not Langamurti v.

The Central Drugs Laboratory.– test. made under this Chapter: d) the matter necessary to be prescribed (2) The Central Government may. make sub-section (1).Section 6 and 7 not to apply to Laboratory. THE CENTRAL DRUGS LABORATORY AND THE DRUGS CONSULTATIVE COMMITTEE 6. establish a Central Drugs in respect of such reports. Laboratory under the control of a c) such other matters as may be Director to be appointed by the Central necessary or expedient to enable the Government.– b) the procedure for the submission of Nothing contained in section 5 and 7 the said Laboratory [under Chapter shall apply to [Ayurvedic.] drugs [or cosmetics] for analysis or . Siddha or Unani drugs. rules prescribing – a) the functions of the Central Drugs 7A. forms of the Laboratory’s (1) The Central Government shall. Ayurvedic.CHAPTER II THE DRUGS TECHNICAL ADVISORY BOARD. as reports thereon and the fees payable soon as may be. Siddha or IV or Chapter IVA] of samples of Unani drugs. to carry out the functions said Laboratory to carry out its entrusted to it by this Act or any rules functions. for the purposes of the proviso to after consultation with the Board.

that Government may.– (1) The law for the time who was the smuggler. Cosmetics in Public Interest. India formulations which would on the whole and if necessary. Shermal Jain v. notification in the Official Gazette. and any drug or cosmetic is likely to involve officers of Customs and officers any risk to human beings or animals or empowered under that Act to perform that any drug does not have the the duties imposed thereby on a therapeutic value claimed for it or [Commissioner of Customs] and other contains ingredients and in such quantity officers of Customs shall have the same for which there is no therapeutic powers in respect of such drugs [and justification and that in the public cosmetics] as they have for the time interest it is necessary or expedient so being in respect of such goods as to do then. Union of India. may detain any imported package basis of the expert advice can indeed which is prohibited under this Chapter adopt an approved national policy and and shall for thwith repor t such prescribe an adequate number of detention to the Drugs Controller. forward the package meet the requirement of the people at or sample of any suspected drug [or large. Application of Law Relating to personally against any person and Sea Customs and Powers of Customs without coming to a finding as to Officers. IMPORT OF DRUGS AND COSMETICS CHAPTER III 10A. Power of Central Government prohibited by section 18 of the Sea to Prohibit Import of Drugs and Customs Act. if the Central [and cosmetics] the import of which is Government is satisfied that the use of prohibited under this Chapter. AIR COMMENTS 1987 SC 990. 1878 (8 of 1878) shall.– subject to the provisions of section 13 Without prejudice to any other provision of this Act. by aforesaid.] [Commissioner of Customs] or any officer of the Government authorized COMMENTS by the Central Government in this The Central Government on the behalf. Vincent Panikurlangara v. AIR 1956 Cal and to goods the import of which is 621. injurious drugs should be Drugs Laboratory] totally eliminated from the market. apply in respect of drugs contained in this Chapter. . being in force relating to sea customs Collector of Central Excise. i) The tainted goods may be confiscated without proceeding 11. (2) Without prejudice to the prohibit the import of such drug or provisions of sub-section (1) the cosmetic. While laying the guidelines on cosmetic] found therein to the Central this score.

custom authorities to prove the c) prescribe in respect of biological and breach of prohibition order. or mitigate] and such other effects make rules for the purpose of giving which such drug may not purport effect to the provisions of this or claim to have.14 LEGAL STATUS OF AYURVEDIC. SIDDHA AND UNANI MEDICINES ii) Mere unlawful possession of b) prescribe the methods of test or prohibited goods does not lead to analysis to be employed in conclusion that the goods had been determining whether a drug [or imported unlawfully. test or licence is issued is not complied analysis. test or analysis by the chapter or the rules made Central Drugs Laboratory. [after consultation d) specify the diseases or ailments with or on the recommendation of the which an imported drug may not Board] and after previous publication purport or claim [to prevent. . the making of the rules and the Central f) prescribe the places at which drugs Government shall take into [or cosmetics] may be imported. Collector of Customs Air 1965 Cal units or methods of standardization. v. Power of Central Government drug may bear or contain for to Make Rules. Kanungo organometallic compounds. may it necessary to make rules without such be imported for the purpose of consultation. and thereunder is contravened or any of prescribe the fees. amendment of the said rules. 248 (1965) Cri LJ 547. the fees payable therefore and h) regulate the submission by provide for the cancellation. cc) prescribe under clause (d) of [section 9A] the colour or colours which a 12. and consideration any suggestions which the prohibit their import at any other Board may make in relation to the place. of suspension of such licence in any samples of drugs [or cosmetics] for case where any provision of this examination. Onus is on the cosmetic] is of standard quality. if any. g) require the date of manufacture and (2) Without prejudice to the the date of expiry of potency to be generality of the foregoing power.] Government may. the Central Government is of opinion that impor t of which is otherwise circumstances have arisen which render prohibited under this Chapter. [or cosmetics or classes of cosmetics] and prohibit the import of the said for the import of which a licence is drug or class or drug after the expiry required [and prescribe the form and of a specified period from the date conditions of such licences. or importers.– (1) The Central purpose of colouring. same. test or analysis or for shall be consulted within six months of personal use. but in such a case the Board examination. and the securing. with]. Chapter: [Provided that consultation with the e) specify the conditions subject to Board may be dispensed with if the which small quantities of drugs. the & Co. cure by notification in the Official Gazette. such clearly and truly stated on the label rules may – or container of any specified a) specify the drugs or classes of drugs imported drug or class of such drug. payable the conditions subject to which the for such examination. the authority empowered to issue the of manufacture.

whether by accompanying which shall or shall not be included documents or otherwise. from all [including the use of packing or any of the provisions of this material which comes into direct Chapter or the rules made contact with the drugs]. from all this Chapter and the rules made or any provision of this chapter and thereunder. to be poisonous for the purposes of conditionally or otherwise. and specify admission. the procedure of of any poisonous substance which officers of Customs in dealing with may be added to or contained in such evidence. packages or other containers. on the label or wrapper of any k) prescribe the conditions to be imported. SIDDHA AND UNANI MEDICINES 15 i) prescribe the evidence to be packages. LEGAL STATUS OF AYURVEDIC. of o) provide for the exemption. imported drugs [or cosmetics] conditionally or other wise. substances which shall be deemed j) provide for the examination. quality of drugs [or cosmetics] sought m) prescribe the maximum proportion to be imported. medicine containing such drug. patent or proprietary observed in the packing in bottles. and the manner of any imported drug. [India]. thereunder of any specified drug or l) regulate the mode of labelling drugs class of drugs [or cosmetics or class [or cosmetics] imported for sale in or cosmetics] . the rule made thereunder of drugs n) require that the accepted scientific [or cosmetics] imported for the name of any specified drug shall be purpose only of transport through. prohibit the storage at places of import of drugs import of any drug in which that [or cosmetics] detained pending proportion is exceeded. and prescribe the matters supplied. displayed in the prescribed manner and export from. of the in such labels.

CHAPTER IV POWER & PROCEDURE OF INSPECTORS 22. vessel or other about his person. any drug or conveyance referred to in clause (c)]. or is being. or in reason to believe. committed. unless being sold or is stocked or the alleged offence is such that the exhibited or offered for sale. necessary. committed. or possession of the drug or cosmetic stocked or exhibited or offered in respect of which the offence has for sale. not to b) take samples of any drug or dispose of any stock of such drug or cosmetic. cosmetic in respect of which an and seize the same if he has reason offence under this Chapter has to believe that it may furnish been.] assistance. has secreted any place.– (1) Subject which he has reason to believe to the provisions of section 23 and of that an offence under this any rules made by the Central Chapter has been. been. who. he has reason to believe. Government in this behalf. or is being.– cosmetic for a specified period not i) which is being manufactured or exceeding twenty days. or is being. for which he is appointed. possessor of the drug or cosmetic ii) from any person who is in the seize the stock of such drug or course of conveying delivering cosmetic and any substance or article or preparing to deliver such drug by means of which the offence has or cosmetic to a purchaser or a been. ii) any premises wherein any drug and order in writing the person in or cosmetic is being sold. or. if any. or distributed. committed. vehicle. which may be employed for the c) at all reasonable times.– which. Power of Inspectors. with such commission of such offence. register. committed or consignee. i) any premises wherein any drug is being used for carrying any or cosmetic is being drug or cosmetic in respect of manufactured and the means which an offence under this employed for standardizing and Chapter has been or is being. or evidence of the commission of an ii) enter and search any place in offence punishable under this Act .– vessel or other conveyance a) inspect. or defect may be removed by the is being distributed. an Inspector committed or may. he has object found [with any person. within the local limits of the area iii) stop and search any vehicle. or is being. as he considers [cc) examine any record. testing the drug or cosmetic.– document or any other material i) search any person.

so far as may be. he shall tender a receipt therefore in respect of which he has reason to in the prescribed form. record. he shall produce to the . register or other document when (4) The Inspector shall restore one so required under clause (cca) of sub. or other document (2) where the price tendered under relating to the manufacture for sale sub-section (1) is refused or where the or for distribution. in such manner as may be that it is likely to deteriorate or be prescribed.] otherwise damaged by exposure shall. to the imprisonment which may extend to person from whom he takes it. he shall tender the fair price ii) the second. of such person unless he willfully absents (2) The provision of [the Code of himself. record. Chapter. after copies thereof or sample as aforesaid. as the case may be. as of small volume. Provided that where the sample is (2A) Every record.– i) one portion or container he shall (1) Where an Inspector takes any sample forthwith send to the Government of a drug [or cosmetic] under this Analyst for test or analysis. or with fine.] thereof and may require a written [cca) require any person to produce any acknowledgement therefore. believe that an offence under this (3) Where an Inspector takes a Chapter has been. Procedure of Inspectors. 1973 (2 of 1974)] portions and effectively seal and suitably shall. extracts there from certified by that and if the drug [or cosmetic] be such person. in the presence made thereunder. from whom they into three portions only: were seized or who produce the same. this Chapter [or refuses to produce any sealing them. shall divide the sample into four Criminal Procedure. he shall d) exercise such other powers as may intimate such purpose in writing in the be necessary for carrying out the prescribed form to the person from purpose of this Chapter or any rules whom he takes it and. offer for sale or [or cosmetic] under clause (c) of section distribution of any drug or cosmetic 22. it produced under clause (cca) shall be shall be necessary to divide the sample returned to the person. under of the said Code. register. the Inspector may. stocking Inspector seizes the stock of any drug exhibition for sale. portion of a sample so divided or one section (1). apply to any mark the same and permit such person search or seizure under this Chapter as to add his own seal and mark to all or they apply to any search or seizure made any of the portions so sealed and under the authority of a warrant issued marked. register or other taken from premises whereon the drug document seized under clause (cc) or [or cosmetic] is being manufactured. (3) If any person willfully obstructs take three or four. instead of dividing a the case may be. and shall three years. where necessary. have been taken. LEGAL STATUS OF AYURVEDIC. or with both.] he shall be punishable with container. sample of a drug [or cosmetic] for the committed purpose of test or analysis.] retain the remainder and dispose of the same as follows:- 23. as the case may be. SIDDHA AND UNANI MEDICINES 17 or the Rules made thereunder. Provided further that where the drug within a period of twenty days of the [or cosmetic] is made up in containers date of such seizure or production. an Inspector in the exercise of the of the said containers after suitably powers conferred upon him by or under marking the same and. or is being.

whose name.– Every person intention of adducing evidence in for the time being in charge of any controversion of a Government premises whereon any drug [or cosmetic] Analyst’s report. inform [a judicial are pending that he intends to adduce Magistrate] and take his orders as to the evidence in controversion of the report. (4) Unless the sample has already been tested or analysed in the Central 24. on being required request either of the complaint or the . the Court may. he shall. address and other particulars have been disclosed under section 18A. he shall send being manufactured or is kept. Persons Bound to Disclose Place Drugs Laboratory. under section 18A] has within twenty- [(6) Where an Inspector seizes any eight days of the receipt of a copy of the record. he shall. of its is being manufactured or is kept for sale own motion or in its discretion at the or distribution shall. where a person has where Drugs or Cosmetics are under sub-section (3) notified his Manufactured or Kept. 25.18 LEGAL STATUS OF AYURVEDIC. inform [a judicial Magistrate] and section 18A] and shall retain the third take his orders as to the custody copy for use in any prosecution in thereof. SIDDHA AND UNANI MEDICINES Court before which proceedings if by any Inspector so to do. or the Cour t before which any section (1) of section 22. as the to the person. notified in writing the Inspector material object under clause (cc) of sub. Reports of Government (5) Where an Inspector takes any Analysts. forthwith [or the person whose name. taken [and another copy to the person. b) if he seizes the stock of the drug [or if any whose name address and other cosmetic] he shall as soon as may particulars have been disclosed under be. as proceedings in respect of the sample soon as may be. be legally any. c) without prejudice to the institution (3) Any document purporting to be of any prosecution.– (1) The Government action under clause (c) of section 22. where taken. address and revoke his order under the said other particulars have been disclosed clause. custody thereof. as the case (2) The Inspector on receipt thereof may be take such action as may be shall deliver one copy of the report to necessary for return of the stock the person from whom the sample was seized.– Analyst to whom a sample of any drug a) he shall use all dispatch in [or cosmetic] has been submitted for ascertaining whether or not the drug test or analysis under sub-section (4) of [or ascertained that the drug [or section 23. respect of the sample. evidence shall be conclusive unless the on being satisfied that the defect person from whom the sample was taken has been so remedied. if any. document or any other report. case may be. shall deliver to the Inspector cosmetic] does not so contravene submitting it a signed report in triplicate forthwith revoke the order passed in the prescribed form. are instituted in respect of the bound to disclose to the Inspector the drug [or cosmetic] and place where the drug [or cosmetic] is iii) the third. register. if the alleged a report signed by a Government Analyst contravention be such that the defect under this Chapter shall be evidence of may be remedied by the possessor the facts stated therein and such of the drug [or cosmetic]. under the said clause or.

to Prohibit Manufacture. then that for test or analysis to a Government Government may. on application in the therapeutic justification and that in the prescribed manner and on payment of public interest it is necessar y or the prescribed fee. and such report shall be conclusive evidence of 26a. signed by or under the authority of.. SIDDHA AND UNANI MEDICINES 19 accused: cause the sample of the drug by the Government Analyst. by notification in the Analyst any drug [or cosmetic] Official Gazette. satisfied. be entitled to submit expedient so to do. LEGAL STATUS OF AYURVEDIC. of (5) The cost of a test or analysis Drug and Cosmetic in Public made by the Central Drugs Laboratory Interest. whether such it or contains ingredients and in such person is a member of that association quantity for which there is no or not] shall. prohibit the [purchased by him or it] and to receive manufacture. etc. the 1956 or any other law for the time being Director of the Central Drugs in force. which shall make voluntar y consumer association the test or analysis and report in writing registered under the Companies Act. sale or distribution of such a report of such test or analysis signed drug or cosmetic] .– Without prejudice to any under sub-section (4) shall be paid by other provision contained in this the complainant or accused as the Court Chapter.] Laboratory the result thereof.– drug does not have the therapeutic value Any person [or any recognized claimed or purported to be claimed for consumer association. if the Central Government is shall direct. [or cosmetic] produced before the [Explanation– For the purposes of Magistrate under sub-section (4) of this section and section 32. Power of Central Government the facts stated therein. “recognized section 23 to be sent for test or analysis consumer association” means a to the said Laboratory. Purchase of Drug or Cosmetic human beings or animals or that any Enabled to Obtain Test or Analysis. that the use of any drug or cosmetic is likely to involve any risk to 26.

Chairman. one each from among ii) the Drugs Controller. Services. (1) The Central Government shall. to it by this Chapter. officio. the Central Government. ex officio. specified therein. procedure and conduct of all business viii) four persons to be nominated by to be transacted by it. make bye-laws fixing a vii) one Phyto-chemist to be nominated quorum and regulating its own by the Central Government. Ministry of Health. ex the practitioners of Ayurvedic. xiii) three persons. (5) The Board may. namely– drug industry. [Ayurvedic. SIDDHA AND UNANI DRUGS] 33-C.] – Pharmacopoeia Committee. by ix) one teacher in Darvyaguna.CHAPTER IVA PROVISION RELATING TO [AYURVEDIC. India. Siddha and Unani the Siddha and Unani Drugs Technical Advisory Board. (3) The Central Government shall iv) the director of the Central Drugs appoint a member of the Board as its laboratory. vacancy therein. subject to the vi) one Pharmacognocist to be nomi. v) one person holding the appointment (4) The nominated members of the of Government Analyst under Board shall hold office for three years Section 33-F to be nominated by but shall be eligible for re-nomination. ex officio. the State Governments on technical xi) one teacher in Gunapadam to be matters arising out of this Chapter and nominated by the Central to carry out the other functions assigned Government. one from amongst the members of (7) The Central Government shall . one each to represent (2) The Board shall consist of the the Ayurvedic. to be nominated with effect from such date as may be by the Central Government. xii) three persons. Siddha and Unani Tibb systems of iii) The principal officer dealing with medicine to be nominated by the Indian systems of medicine in the Central Government. two from (6) The functions of the board may amongst the members of the Ayur. to be nominated by i) The Director-General of Health the Central Government. previous approval of the Central nated by the Central Government. ex officio. Calcutta. to be Unani Drugs Technical Advisory Board] nominated by the Central to advise the Central Government and Government. Siddha and Unani following members. the Central Government. be exercised notwithstanding any vedic Pharmacopoeia Committee. Government. constitute a Board (to x) one teacher in Ilm-ul-Advia and be called the [Ayurvedic. Siddha and Taklis-wa-Dawasazi. and notification in the Official Gazette and Bhaishajya kalpana.

or c) if its label or container or anything b) if it has been prepared. Unani Drugs Consultative Committee plead that the prohibition is shall meet when required to do so by unreasonable or violative of his right the Central Government and shall Article 304 (b) of the Constitution of regulate its own procedure. Misbranded Drugs. sell and exhibit Government. Adulterated Drugs. indeed.– a) if it is so coloured. sells and exhibits such Ayurvedic. LEGAL STATUS OF AYURVEDIC. Siddha and Unani Drugs enforcement of these provisions by a Technical Advisory Board on any matter State. in such a state. The Ayurvedic. the liquor or selling and consuming the Siddha or Unani drug shall be deemed same. cannot be questioned for the purpose of securing uniformity either by manufacturer of such drugs throughout India in the administration being located. the the Ayurvedic. the prohibition is enforced of each State to be nominated by the while in an another prohibition is not State Government concerned. or the of this Act in so far as it relates by dealer who stocks. concealed. in which prohibition imposed. 1940. COMMENT 33-D. necessary. powdered 33-EE. can the affected person in the (3) The Ayurvedic. packed or accompanying the drug bears any stored under insanitary conditions . of b) if it is not labelled in the prescribed any filthy.– For the prohibited either from manufacturing purpose of this Chapter an Ayurvedic. the State Government and unlicensed drugs. to be misbranded. sell and exhibits the nominated by the Central Government drugs manufactured without a licence as representatives of that Government as the case may be Say for example. constitutional Committee. and not more than one representative in one State. is not in dispute. Such a plea is not sustainable. or substance. if. stock. an Ayurvedic. in whole or in part.– (1) The Central or otherwise of the requirement of a Government may constitute an advisory licence for manufacturing the drugs Committee to be called the Ayurvedic. and of Committee to advise the Central the prohibition to stock.– For the or polished that damage is purpose of this Chapter. design or device which board and shall provide the Board with makes any false claim for the drug such clerical and other staff as the or which is false or misleading in Central Government considers any particular. drugs. Siddha and State. Siddha and Plea of no prohibition in other state not Unani Drugs Consultative sustainable – If the legality. or if it is made to appear Siddha or Unani drug shall be deemed of better or greater therapeutic value to be adulterated:– than it really is. Siddha or Unani drugs. or a) if it consists. coated. on the ground that their (2) The Ayurvedic. envisaged under Section 33-D of the Siddha and Unani Drugs Consultative Drugs and Cosmetics Act. putrid or decomposed manner. enforced. Siddha and counterparts in other states are not Unani Drugs Consultative Committee required to take a licence to shall consist of two persons to be manufacture. SIDDHA AND UNANI MEDICINES 21 appoint a person to be Secretary of the statement. India merely on the ground that his counter parts in the other State are not 33-E.

a drug shall not be deemed standards. Siddha or Unani drug Explanation:– For the purpose of except in accordance with such clause (a). Regulation of Manufacturer injurious to health. or of the drug. or bears upon it or iii) any Ayurvedic. e) if it contains any harmful or toxic substance which may render it 33-EEB. of any in relation to that drug. and Ayurvedic. i) any misbranded. . Siddha or Unani upon its label or container the name drug in contravention of any of of another drug. SIDDHA AND UNANI MEDICINES whereby it may have been c) if the label or container bears the contaminated with filth or whereby name of an individual or company it may have been rendered injurious purporting to be the manufacturer to health. a) if it is sold. adulterated or Siddha or Unani drug shall be deemed spurious Ayurvedic. if any as may be prescribed to consist. in whole or in part. dicomposed substance only by reason of the fact that such decomposed 33-EEC. by is not due to any negligence on the part notification in the Official Gazette. or a product.22 LEGAL STATUS OF AYURVEDIC. or offered or exhibited ii) any patent or proprietar y for sale. which individual or c) if its container is composed. unless it is plainly the provisions of this Chapter and conspicuously marked so as to or any rule made thereunder. or is an manner on the label or container substitute for.– No person shall therewith so as to reduce its quality manufacturer for sale or for distribution or strength. reveal its true character and its lack b) sell. a) manufacture for sale or for 33-EEA. either dealer thereof and that it does not render by himself or by any other person on the drug injurious to health. or displayed in the prescribed b) if it is an imitation of. Siddha and f) if any substance has been mixed Unani Drugs. or d) if it bears or contains for purpose of e) if it purports to be the product of a colouring only. Siddha or to be spurious. no person. Spurious Drugs. of the manufacturer of the drug or the specify in this behalf. a colour other than manufacturer of whom it is not truly one which is prescribed.– From such Provided that such decomposition date as the State Government may. under a name which belongs medicine. Prohibition of Manufacture substance is the result of any natural and Sale of Certain Ayurvedic. his behalf shall. stock or exhibit or offer for of identity with such other drug. or substance. and likely to deceive.– For the distribution. or for Sale of Ayurvedic. of any poisonous or or deleterious substance which may d) if it has been substituted wholly or render the contents injurious to in part by any other drug or health. another drug or thereof the true list of all the resembles another drug in a manner ingredients contained in it. decomposition of the drug: Siddha and Unani Drugs.– purpose of this Chapter.– Unani drug. unless there is to another drug. any Ayurvedic. or sale or distribute any Ayurvedic. in whole company is fictitious does not exist. or in part.

etc. by Inspector under this section. neither the a licence issued for such purpose Central Government nor a State under this Chapter by the prescribed Government shall appoint as a authority: Government Analysts. value claimed or purported to be (3) No person who has any financial claimed for it and that in the public interest in the manufacture or sale of interest it is necessary or expedient so any drug shall be appointed to be an to do then. of Ayurvedic. to be Government of any of the provisions of this Act. by notification in the official 33-EED. having their prescribed been manufactured in contravention qualifications. SIDDHA AND UNANI MEDICINES 23 Siddha or Unani drug which has as it thinks fit. assigned to them by the Central c) manufacture for sale or for Government or the State Government.– (1) The Central examination.– Without prejudice to any Central Government or the State other provision contained in this Government.– (1) The officially subordinate to such authority Central Government or a State as the Government appointing him may Government may. as the case may be. that Government may. by notification in the specify in this behalf. Chapter. of Government Analyst under this section. any drug shall be appointed to be a subject to the prescribed conditions. small quantities of any Ayurvedic. appoint such person . having the prescribed Manufacturer. or Unani drug. notification in the Official Gazette. who has any financial Provided further that nothing in this interest in the manufacture or sale of section shall apply to the manufacturer. any Ayurvedic. he is serving. Inspectors. except under. Analysts for such areas as may be or any rule made thereunder. test or analysis. any official not Provided that nothing in this section serving under it. Siddha or Unani drug for the purpose of 33-G. Government Analysts. and in (2) Notwithstanding anything accordance with the conditions of. appoint such persons as it Government to Prohibit thinks fit. Siddha or Unani which. LEGAL STATUS OF AYURVEDIC. limitations or restrictions Unani drug is likely to involve any risk subject to which such power and duties to human beings or animals or that any may be exercised or performed shall be such drug does not have the therapeutic such as may be prescribed. meaning of Section 21 of the Indian Penal Code (45 to 1860) and shall be 33-F. (4) Every Inspector shall be deemed prohibit the manufacture. Power of Central Gazette. Official Gazette. qualification. if the Central Government is (2) The powers which may be satisfied on the basis of any evidence or exercised by an Inspector and the duties other material available before it that which may be performed by him and the use of any Ayurvedic. Siddha as the case may be. to be Inspectors for such Siddha or Unani Drugs in Public areas as may be assigned to them by the Interest. distribution. contained in sub-section (1).. Government or a State Government may. sale or to be a public servant within the distribution of such drug. without the previous shall apply to Vaidyas and Hakims who consent of the Government under manufacture Ayurvedic. Siddha or the conditions. drug for the use of their own patients: (3) No person.

of Ayurvedic. be punishable with imprisonment i) deemed to be adulterated under for a term which shall not be less Section 33-EE. so far as may be apply in relation rule made under this Chapter. Siddha or Unani drug”.23. Confiscation. any adequate and special reasons to be mentioned in the judgment. the stock of the Ayurvedic. and with fine which shall not be Provided that the Court may. Siddha or Unani drug of fine of less than five thousand deemed to be spurious under rupees: Section 33EEA. shall not be less than two impose a sentence of imprisonment thousand rupees. a) under clause (a) of sub-section 33- 1 is again convicted of an offence 33-I.. shall drug. shall be Offences. Penalty for Subsequent “drug” in the said sections. Sale. Penalty for Manufacture.– Whoever himself or by any and with fine which shall not be other person on his behalf – (1) less than two thousand rupees. impose a 33-K.24 LEGAL STATUS OF AYURVEDIC. under that. Application of Provisions of than five thousand rupees: or Sections 22. or than two years but which may extend ii) without a valid licence as to six years and with fine which shall required under clause © of not be less than five thousand Section 33-EEC.24 and 25 provisions of this Chapter or of Section and the rules. for a term of less than two years and b) any Ayurvedic. for less than one thousand rupees.– The (2) Contravenes any other provisions of Sections 22. shall be punishable c) under sub-section (2) of Section 33- with imprisonment for a term which I is again convicted of an offence shall not be less than one year but under that sub-section. Siddha or Unani an offence under that clause.– Whoever having been constructed as references to “Ayurvedic. under Chapter IV. clause. shall be to an Inspector and a Government punishable with imprisonment for a term Analyst appointed under this Chapter which may extend to three months and as they apply in relation to an Inspector with fine which shall not be less than and a Government Analyst appointed five hundred rupees. . Siddha or Unani punishable with imprisonment for a Drug in Contravention of this term which may extend to two years Chapter. manufactures for sale or for b) under clause (b) of sub-section (1) distribution. 24 and 25. shall be rupees: punishable with imprisonment Provided that the Court may. 23. convicted of an offence.– of Section 33-I is again convicted of a) any Ayurvedic. shall be etc. if any made there under 24 as applied by Section 33-H or any shall.– Where any sentence of imprisonment for a term of person has been convicted under this less than one year and of fine of less Chapter. for for a term which may extend to any adequate and special reasons to one year and with fine which be mentioned in the judgment. subject to the modification that the references to 33-J. shall be which may extend to three years and punishable with imprisonment for a with fine which shall not be less term which may extent to six months than five thousand rupees. SIDDHA AND UNANI MEDICINES 33-H.

of Government Analysts and the sale or distribution of any Ayurvedic. Power of Central Government the fees payable therefore [and to make Rules.– The laboratories for testing and analyzing provisions of this Chapter except those Ayurvedic. Siddha or Unani drugs. SIDDHA AND UNANI MEDICINES 25 Siddha or Unani drug. licences may be issued. Cognizance of Offences. is contravened or any of the make rules for the first purpose of giving conditions subject to which they are effect to the provisions of this Chapter: issued is not complied with]. Board may make in relation to the Siddha or Unani drugs may be . or on the recommendation of. in respect of amendment of the said rules. such rules may.] the form Metropolitan Magistrate or of a judicial application for such licences. which the contravention has been made. shall be instituted except by an Inspector e) prescribe the forms of licences for [with the previous sanction of the the manufacture for sale of authority specified under sub-section (4) Ayurvedic. contained in Section 33-K shall apply b) prescribe the qualification and duties in relation to the manufacture for sale.– d) specify any substance as a poisonous (1) No prosecution under this Chapter substance.– 33-L. of Section 33-G. sale or determining whether any Ayurvedic. the Magistrate of the first class] shall try an conditions subject to which such offence punishable under this Chapter. Siddha or Unani drug by any department c) prescribe the methods of test or of Government as they apply in relation analysis to be employed in to the manufacture for sale. regulate the mode of labelling consultation. (2) Without prejudice to the shall be liable to confiscation. qualification of Inspectors. Application of Provisions to a) provide for the establishment of Government Departments. [after consultation suspension of such licences in any with. Siddha or Unani drugs. generality of the foregoing power. (2) No Court inferior to that [or a Siddha or unani drugs. Siddha or Unani drugs Central Government is of opinion that including the use of packing material circumstances have arisen which render which comes into contact with the it necessary to make rules without such drugs. the authority empowered to issue the same and 33-N.– (1) The Central provide for the cancellation or Government may.] the Central Government shall take into g) prescribe the conditions subject to consideration any suggestions which the which small quantities of Ayurvedic. [(f) prescribe the conditions to be Provided that consultation with the obser ved in the packing of Board may be dispensed with if the Ayurvedic. the case where any provision of this Board] and after previous publication Chapter or rules made there under by notification in the Official Gazette. [and for sale of processed Ayurvedic. the true list of the ingredients which it is purported to contain. LEGAL STATUS OF AYURVEDIC. 33-M. the packed drugs and prescribe the Board shall be consulted within six matters which shall not be included months of the making of the rules and in such labels. but in such a case. distribution of such drug by any other Siddha or Unani drug is labelled with person.

not less than three months’ be inserted. namely:– examination.– The State Government may. therefore” shall be deleted. the following section shall Gazette. Sec. 4. purpose of colouring. Ayurvedic. 33-O. by amend the First Schedule for the notification in the Official Gazette and purpose of this Chapter and thereupon subject to the condition of previous the said Schedule shall be deemed to be publication. by notification in Official principal Act. Power to amend First Schedule. add to or otherwise rules. Siddha or Unani drugs wherein any Ayurvedic. (e) the words “and the fees payable Sec. Unani drug may bear or contain for Siddha or Unani drugs.] and Unani drugs is being or is proposed h) any other matter which is to be or to be manufactured: may be prescribed under this c) test or analysis of any Ayurvedic. a) grant or renewal of all licence for [(gg) prescribe under clause (a) of the manufacture for sale of Section 33-EE the colour or colours Ayurvedic. which an Ayurvedic. – Vide Maharashtra Act 31 of 1989. SECTION 33-N-1 after consultation with the Board and Maharashta. Siddha or Unani drug by Government Analyst.” principal Act in sub-section (2) in clause Vide Maharashtra Act 31 of 1989.– After Section 33-N after giving. may.26 LEGAL STATUS OF AYURVEDIC.– The Central Government. b) inspection (for the purpose of grant (gga) prescribe the standards for or renewal of licences) of premises. SIDDHA AND UNANI MEDICINES manufactured for the purpose of of this Chapter. In Section 33-N of the be prescribed under this Chapter. make rules to prescribe the amended accordingly. Siddha or Unani drugs. and STATE AMENDMENTS d) any other matter for which fees may Maharashtra. test or analysis. 4. by “33-N-I Power of State Government to make a like notification. Chapter. Siddha or and for sale of processed Ayurvedic. namely:– notice to its intention so to do. Siddha or under Section 33-EEB. fees payable for the following purpose .

Offences by Government responsible to the company for the Departments.– director.– For the purposes of this provisions of this Act or of any rule or section – order made thereunder.– (1) association of individuals. manager. as the case may be. and Where an offence under this Act has b) “director” in relation to a firm means been committed by a company. execution in the State any of the Explanation. or is his knowledge or that such authority attributable to any neglect on the part or person exercised all due diligence of.] a) “company” means a body corporate. where an punishment provided in Chapter IV or offence under this Act has been Chapter IVA. under Chapter IV or Chapter IVA has as well as the company shall be deemed been committed by any department of to be guilty of the offence and shall be Government. was in charge of. secretary or to prevent the commission of such other officer of the company. manager. Offences by Companies.] Power to Give Directions. person who at the time the offence was committed. sale or Provided that nothing contained in distribution of drugs or where no this sub-section shall render any such authority is specified. and was [34a. this section shall render any such (2) Notwithstanding anything authority or person liable to any contained in sub-section (1).– Where an offence conduct of the business of the company. shall be deemed to be guilty provided in this Act if he proves that of the offence and shall be liable to be the offence was committed without his proceeded against and punished knowledge or that he exercised all due accordingly: diligence to prevent the commission of Provided that nothing contained in such offence. any director. and includes a firm or other 34.] . such offence. if such committed by a company and it is proved authority or person proves that the that the offence has been committed offence was committed without its or with the consent or connivance of. secretary or other The Central Government may give such officer shall also be deemed to be guilty directions to any State Government as of that offence and shall be liable to be may appear to the Central Government proceeded against and punished to be necessary for carrying into accordingly. such authority as is liable to be proceeded against and specified by the Central Government to punished accordingly: be in charge of manufacture. every a partner in the firm. MISCELLANEOUS CHAPTER V [33p. the head of the person liable to any punishment department.

28 LEGAL STATUS OF AYURVEDIC, SIDDHA AND UNANI MEDICINES

[34aa. Penalty for Vexatious Search Metropolitan Magistrate or any Judicial
Or Seizure. – Any Inspector exercising Magistrate of the first class] to pass any
powers under this Act or the rules made sentence authorized by this Act in excess
thereunder, who,– of his powers under the said Code.
a) without reasonable ground of
suspicion searches any place, vehicle, [36a. Certain Offences to be Tried
vessel or other conveyance; or Summarily.– Notwithstanding anything
b) vexatiously and unnecessarily contained in the Code of Criminal
searches any person; or Procedure, 1973 (2 of 1974), all offences
c) vexatiously and unnecessarily seizes under this Act, punishable with
any drug or cosmetic, or any imprisonment for a term not exceeding
substance or article, or any record, three years, other than an offence under
register, document or other material clause (b) of sub-section (1) of section
object; or 33-I, shall be tried in a summary way by
d) commits, as such Inspector, any a Judicial Magistrate of the first class
other act, to the injury of any person specially empowered in this behalf by
without having reason to believe that the State Government or by a
such act is required for the execution Metropolitan Magistrate and the
of his duty, shall be punishable with provisions of sections 262 to 265 (both
fine which may extend to one inclusive) of the said Code shall, as far
thousand rupees.] as may be, apply to such trial:
Provided that, in the case of any
35. Publication of Sentences passed conviction in a summary trial under this
under this Act.– (1) If any person is section, it shall be lawful for the
convicted of an offence under this Act, Magistrate to pass a sentence of
[the Court before which the conviction imprisonment for a term not exceeding
takes place shall, on application made one year:
to it by the Inspector, cause] the Provided further that when at the
offender’s name, place of residence, the commencement of, or in the course of,
offence of which he has been convicted a summary trial under this section it
and the penalty which has been inflicted appears to the Magistrate that the nature
upon him, to be published at the expense of the case is such that a sentence of
of such person in such newspapers or imprisonment for a term exceeding one
in such other manner as the Court may year may have to be passed or that it is,
direct. for any other reason, undesirable to try
(2) The expenses of such publication the case summarily, the Magistrate shall,
shall be deemed to form part of the after hearing the parties, record an order
costs relating to the conviction and shall to that effect and thereafter recall any
be recoverable in the same manner as witness who has been examined and
those costs are recoverable. proceed to hear or rehear the case in
the manner provided by the said Code.]
36. Magistrate’s Power to Impose
Enhanced Penalties.– 37. Protection of Action taken in
Notwithstanding anything contained in Good Faith.– No suit, prosecution or
the code of Criminal Procedure, 1973 other legal proceeding shall lie against
(2 of 1974)] it shall be lawful for [any any person for anything which is in good

LEGAL STATUS OF AYURVEDIC, SIDDHA AND UNANI MEDICINES 29

faith done or intended to be done under following the session or the successive
this Act.] sessions aforesaid], both Houses agree
in making any modification in the rule
38. Rules to be laid before or both Houses agree that the rule
Parliament.– Every rule made under should not be made, the rule shall
this Act shall be laid as soon as may be thereafter have effect only in such
after it is made before each House of modified form or be of no effect, as the
Parliament while it is in session for a case may be; so however that any such
total period of thirty days which may be modification or annulment shall be
comprised in one session or in two or without prejudice to the validity of
more successive sessions, [and if, before anything previously done under that
the expiry of the session immediately rule.]

30 LEGAL STATUS OF AYURVEDIC, SIDDHA AND UNANI MEDICINES

THE FIRST SCHEDULE
[A. AYURVEDIC AND SIDDHA SYSTEMS]

Ayurveda 38. Vaidya Jiwan 68. Veeramamuni Nasa Kandam
1. Arogya Kalpadruma 39. Basava Rajeeyam 69. Agasthiyar (600)
2. Arka Prakasha 40. Yoga Ratnakara 70. Agasthiyar kanma Soothiram
3. Arya Bhishak 41. Yoga Tarangini 71. 18 Siddhar’s Chillarai Kovai
4. Ashtanga Hridaya 42. Yoga Chintamani 72. Yogi Vatha Kaviyam
5. Ashtanga Samgraha 43. Kashyapasamhita 73. Therayar Tharu
6. Ayurveda Kalpadruma 44. Bhelasamhita 74. Agasthiyar Vaidya Kaviyam
7. Ayurveda Prakasha 45. Vishwanathachikitsa (1500)
8. Ayurveda Samgraha 46. Vrindachikitsa 75. Bala Vagadam
9. Bhaishajya Ratnavali 47. Ayurvedachintamani 76. Chimittu Rathna (Rathna)
10. Bharat Bhaishajya Ratnakara 48. Ayurvedachintamani Churukkam
11. Bhava Prakasha 49. Ayurveda – ratnakar 77. Nagamuni (200)
12. Brihat Nighantu Ratnakara 50. Yogaratnasangraha 78. Agasthiyar Chillarai Kovai
13. Charaka Samhita 51. Rasamrita 79. Chikicha Rathna Deepam
14. Chakra Datta 52. Dravyagunanighantu 80. Agasthiyar Nayana Vidhi
15. Gada Nigraha 53. Rasamanijari 81. Yugi Karisal (151)
16. Kupi Pakva Rasayana 54. Bangasena 82. Agasthiyar Vallathi (600)
17. Nighantu Ratnakara 54-A.Ayurvedic Formulary of 83. Therayar Thaila Varkam
18. Rasa Chandanshu India 84. Siddha Formulary of India
19. Rasa Raja Sundara 54-B. Ayurveda Sara Sangraha
20. Rasaratna Samuchaya 54-C. Ayurvedic Pharmacopoeia Unani Medicine (Part-1)
21. Rasatantra Sara Siddha of India
Prayoga Samgraha B. – UNANI TIBB SYSTEM
22. Rasa Tarangini Siddha 1. Karabadin Qadri
23. Rasa Yoga Sagara 55. Siddha Vaidya Thirattu 2. Karabadin Kabir
24. Rasa Yoga Ratnakara 56. Therayar Maha Karisal 3. Karabadin Azam
25. Rasa Yoga Samgraha 57. Brahma Muni Karukkadai 4. IIaj-ul-Azam
26. Rasendra Sara Samgraha 58. Bhogar (700) 5. Al Karabadin Jadid
27. Rasa Pradipika 59. Pulippani (500) 6. Biaz Kabir Vol. II
28. Sahasrayoga 60. Agasthiyar Paripuranam 7. Karabadin Jadid
29. Sarvaroga Chikitsa Ratnam (400) 8. Kitalf-ul-Taklis
30. Sarvayoga Chikitsa Ratnam 61. Therayar Yamagam 9. Sanat-ul-Taklis
31. Sharangadhara Samhita 62. Agasthiyar Chenduram (300) 10. Mifta-ul-Khazain
32. Siddha Bhaishajya Manimala 63. Agasthiyar (1500) 11. Madan-ul-Aksir
33. Siddha Yoga Samgraha 64. Athmarakshamrutham 12. Makhzan-ul-Murabbat
34. Sushruta Samhita 65. Agasthiyar Pin(80) 13. National Formulary of
35. Vaidya Chintamani 66. Agasthiyar Rathna Unani Medicine
36. Vaidyaka Shabda Sindu Churukkam 14. Unani Pharmacopoeia of
37. Vaidyaka Chikitsa Sara 67. Therayar Karisal (300) India

DRUGS AND COSMETICS RULES. 1945 .

PART XVI MANUFACTURE FOR SALE OF AYURVEDIC,
(INCLUDING SIDDHA) OR UNANI DRUGS

151. Mmanufacture on More Than (2) [A fee of rupees three hundred
One Set of Premises.– If Ayurvedic [shall be payable for a duplicate copy of
(including Siddha) or Unani drugs are a licence issued under this rule, if the
manufactured on more than one set of original licence is defaced, damaged or
premises, a separate application shall be lost.
made and a separate licence shall be
obtained in respect of each such set of 153A. Loan Licence.– (1) An
premises. application for the grant or renewal of
a loan licence to manufacture for sale of
152. Licensing Authorities.–For the any Ayurvedic (including Siddha) or
pur pose of this Par t the State Unani drugs shall be made in Form 25E
Government shall appoint such licensing to the licensing authority along with [a
authorities and for such areas as may be fee of rupees six hundred]
specified in this behalf by notification Explanation:– For the purpose of this
in the Official Gazette. rule, a loan licence means a licence
which a licensing authority may issue to
153. Application for Licence to an applicant who does not have his own
Manufacture Ayurvedic (including arrangements for manufacture but
Siddha) or Unani Drugs.– (1) An intends to avail himself of the
application for the grant or renewal of manufacturing facilities owned by a
a licence to manufacture for sale any licensee in Form 25D.
Ayurvedic (including Siddha) or Unani Provided that in the case of renewal
drugs shall be made in Form 24D to the the applicant may apply for the renewal
licensing authority along with [a fee of of the licence before its expiry or within
rupees one thousand] one month of such expiry.
Provided that in the case of renewal Provided further that the applicant
the applicant may apply for the renewal may apply for renewal after the expiry
of the licence before its expiry or within of one month, but within three months
one month of such expiry: of such expiry in which case [the fee
Provided further that the applicant payable for renewal of such licence be
may apply for renewal after the expiry rupees six hundred plus an additional
of one month but within three months fee of rupees three hundred]
of such expiry in which case [the fee (2) [A fee of rupees one hundred
payable for renewal of such licence shall and fifty] shall be payable for a duplicate
be rupees one thousand and two copy of a licence issued under this rule,
hundred plus an additional fee of rupees if the original licence is defaced,
six hundred] damaged or lost.]

LEGAL STATUS OF AYURVEDIC, SIDDHA AND UNANI MEDICINES 33

154. Form of Licence to Manufacture renewal of a loan licence in Form 25E
Ayurvedic (including Siddha) or shall be issued in Form 26E.]
Unani Drugs.– (1) Subject to the
conditions of rule 157 being fulfilled, a [155B. Certificate of Award of Good
licence to manufacture for sale any Manufacturing Practices Ayurveda,
Ayurvedic (including Siddha) or Unani Siddha and Unani Drugs.– The
drugs shall be issued in Form 25D. The certificate of Good Manufacturing
licence shall be issued within a period Practices (GMP) to manufacturers of
of three months from the date of receipt Ayurvedic (including Siddha) or Unani
of the application. drugs shall be issued to licensee who
(2) A licence under this rule shall comply with the requirements of Good
be granted by the licensing authority Manufacturing Practice (GMP) of
af ter consulting such expert in Ayurvedic Siddha or Unani drugs as laid
Ayurvedic (including Siddha) or Unani down Schedule T.]
systems of medicine, as the case may
be, which the State Government may 156. Duration of Licence.– An
approved in this behalf. original lience in Form 25D or a renewal
licence in Form 26D, unless sooner
[154A. Form of Loan Licence to suspended or cancelled shall be [valid
Manufacture for Sale of Ayurvedic for a period of three years from the date
(including Siddha) or Unani Drugs.– of its issue]
(1) A loan licence to manufacture for Provided that if the application for
sale any Ayurvedic (including Siddha) the renewal of a licence is made before
or Unani drugs shall be issued in Form its expiry or within one month of its
25E. expiry, or if the application is made
(2) A licence under this rule shall within three months of its expiry after
be granted by the licensing authority payment of the [additional fee of rupees
af ter consulting such expert in five hundred], the licence shall be
Ayurvedic (including Siddha) or Unani deemed to have expired, if application
systems of medicine, as the case may for its renewal is not made within three
be, which the State Government may months of its expiry.
approve in this befalf.
(3) The licensing authority shall, 156A. Duration of Loan Licence.–
before the grant of a loan licence, satisfy An original loan licence in Form 25E
himself that the manufacturing unit has or renewed loan licence in Form 26E,
adequate equipment, staff, capacity for unless sooner suspended or cancelled
manufacture and facilities for testing, to shall be [valid for a period of three years
undertake the manufacture on behalf of from the date of its issue]:
the applicant for a loan licnece. Provided that if the application for
the renewal of a licence is made in
155. Certificate of Renewal.– The accordance with rule 153A, the loan
certificate of renewal of a licence licence shall continue to be in force until
in Form 25D shall be issued in Form orders are passed on the application.
26D. The licence shall be deemed to have
expired, if application for its renewal is
[155A. Certificate of Renewal of A not made within three months of its
Loan Licence.– The certificate of expiry.

34 LEGAL STATUS OF AYURVEDIC, SIDDHA AND UNANI MEDICINES

157. Conditions for the Grant or recognized by the Central
Renewal of A Licence in Form 25D.– Government with experience of at
Before a licence in Form 25D is granted least two years in the manufacture
or renewed in Form 26D, the following of drugs pertaining to the diploma
conditions shall be complied with by in Ayurveda, Siddha or Unani
the applicant, namely:– System of medicine, or
(1) The manufacture of Ayurvedic d) a Vaid or Hakim registered in a State
(including Siddha) or Unani drugs shall Register of Practitioners of
be carried out in such premises and indigenous system of medicines
under such hygienic conditions as are having experience of at least four
specified in Schedule T. years in the manufacture of Siddha
[(1A) For getting a certificate of or Unani drugs, or
Good Manufacturing Practices of e) a qualification as Pharmacist in
Ayurveda-Siddha-Unani drugs, the diploma in Ayurvedic (including
applicant shall make an application on Siddha) or Unani System of
a plain paper, providing the information medicine, possessing experience of
on existing infrastructure of the not less than eight years in the
manufacturing unit, and the licensing manufacture of Ayur vedic
authority shall after verification of the (including Siddha) or Unani drugs
requirements as per Schedule T, issue as may be recognized by the Central
the certificate within a period of three Government.
months in Form 26 E-I] (3) The competent technical staff
(2) The manufacture of Ayurvedic to direct and supervise the manufacture
(including Siddha) or Unani drugs shall of Ayur vedic drugs shall have
be conducted under the direction and qualifications in Ayurveda and the
supervision of competent technical staff competent technical staff to direct and
consisting at least of one person, who is supervise the manufacture of Siddha
a whole-time employee and who drugs and Unani drugs shall have
possesses the following qualification, qualifications in Siddha or Unani as the
namely:– case may be.
a) a degree in Ayurveda or Ayurvedic
Pharmacy, Siddha or Unani system 158. Conditions of Licence.– A
of medicine, as the case may be, licence in Form 25D shall be subject to
conferred by a University, a State the conditions stated therein and to the
Government or Statutory Faculties, following further conditions namely:-
Councils and Boards of Indian a) The licensee shall maintain proper
Systems of Medicine recognized by records of the details of manufacture
the Central Government or a State and of the tests, if any, carried out
Government for this purpose, or by him, or by any other person on
b) a diploma in Ayurveda, Siddha or his behalf, of the raw materials and
Unani System of medicine granted finished products.
by a State Government or an b) The licensee shall allow an Inspector
Institution recognized by the Central appointed under the Act to enter
Government for this purpose, or any premises where the manufacture
c) a graduate in Pharmacy or of a substance in respect of which
Pharmaceutical Chemistr y or the licence is issued is carried on to
Chemistry or Botany or a University inspect the premises, to take samples

– 159. if any. wherever tests are d) The licensee shall allow an Inspector available for their genuineness. these would come into force of three months from the date of receipt four months after publication in the of the order which shall. and to inspect the of ascer taining whether the records maintained under these provisions of the Act and the rules rules. c) The licensee shall maintain proper records of the details of manufacture 160. provided (2) A licensee whose licence has that where such fur ther been suspended or cancelled may appeal requirements are specified in the to the State Government within a period rules. have been observed. as may be specified in any any provisions of the Act or the rules rules subsequently made under made thereunder. after giving the licensee an namely:. LEGAL STATUS OF AYURVEDIC.] impressions and the defects noticed. within a a) The licence in Form 25E shall be period which shall not be less than deemed to be cancelled or fifteen days from the date of receipt of suspended. by an order in writing manufacturing facilities have been stating the reasons therefore. wholly or in respect of some of the drugs b) The licensee shall comply with the to which it relates. cancel a availed of by the licensee is cancelled licence issued under this Part or suspend or suspended. Identification of Raw and of the tests. may. why such an order should the licensee in Form 25D whose not be passed. if the licence owned by such notice. or by any other person on preparation of Ayurvedic (including his behalf. Chapter IV A of the Act.– Raw materials used in the by him. af ter Official Gazette. considering the appeal. as the case may be. opportunity to show cause. and appointed under the Act to inspect records of such tests as are carried out all registers and recodes maintained for the purpose and methods thereof under these rules and shall supply shall be maintained. either under these rules. decide the same. the provisions of the Act and of the rules licensee has failed to comply with any and with such further requirements of the conditions of the licence or with if any. Cancellation and Suspension of A licence in Form 25E shall be subject Licences. of the raw materials and Siddha) or Unani drugs shall be finished products.– (1) The licensing authority to the following further conditions. if in his opinion. identified and tested.] to the Inspector such information . SIDDHA AND UNANI MEDICINES 35 of the raw materials as well as the as he may require for the purpose finished products. it for such period as he thinks fit. Conditions of Loan Licence.] 158A. carried out Materials. [c) The licensee shall maintain an e) The licensee shall maintain an Inspection Book in Form 35 to Inspection Book in Form 35 to enable an Inspector to record his enable an Inspector to record his impressions and the defects noticed.

purity. Siddha and for grant or renewal of approval for Unani drugs specified in First Schedule carrying out tests for identity.– For the purpose of Siddha and Unani drugs or the raw this Part. XVII or XVIII of these rules. purity. and referred to as the on behalf of Licensees for “approving authority” under this Part Manufacture of Ayurvedic. as the case may be. applies for renewal of approval after its (2) Before approval in Form 48 is expiry but within six months of such granted or renewed. Form in which Approval to be Government for the purposes of Part Granted for carrying out Tests on XVI. Siddha materials used in the manufacture and Unani drugs” shall also mean and thereof on behalf of licensees for include the raw materials used in the manufacture for sale of the said manufacture of Ayurvedic. the inspection fee payable shall conditions shall be complied with by be six thousand rupees plus an additional the applicants.– Application of testing of Ayurvedic. Siddha and Unani Drugs the case may be.– respect of the drugs specified in First (1) Approval for carrying out such tests Schedule to the Act : of identity. on behalf of licensee for required by it in connection with the manufacture of Ayurvedic. to the Act. quality and strength Provided that the applicant shall of Ayurvedic. shall Unani drugs. Siddha and Ayurvedic. quality and strength of Ayurvedic. namely:– . Siddha and Unani drugs. SIDDHA AND UNANI DRUGS AND RAW MATERIALS USED IN THEIR MANUFACTURE ON BEHALF OF LICENSEES FOR MANUFACTURE FOR SALE OF AYURVEDIC. Application for Grant of inspection fee at the rate of one Approval for Testing Ayurvedic. Explanation.[PART XVI(A) APPROVAL OF INSTITUTIONS FOR CARRYING OUT TESTS ON AYURVEDIC. as Ayurvedic. the words “Ayurvedic. thousand rupees per month in the case Siddha and Unani Drugs. SIDDHA AND UNANI DRUGS 160A. the following expiry. be made in Form 47 to the Licensing Authority appointed by the State 160B. Siddha and application in Form 47 : Unani drugs shall be granted in Form Provided further that if the applicant 48. Siddha and Unani drugs furnish to the approving authority such as may be required under the provisions additional information as may be of these rules. Siddha and shall be accompanied by an and Unani Drugs and Conditions for inspection fee of six thousand rupees in Grant or Renewal of such Approval.

G. nature of tests of any Ayurvedic. Centrifuge machine. provided continues to be 7. Silica crucible. Sieves 10 to 120 with sieve shaker. purity. 11.L. Water bath (temperature controlled). possess a degree in Chemistry. Viscometer (Ostwalds. Polarimeter. 26. adequate space having regard to 2. 25.C. 27. (IC filtrator). Botanist and equipment. separate section shall be 8. (v) Sample Room. Boiling point determination samples of drugs proposed to apparatus. with F. 12. recognized University or 22. Siddha and Unani otherwise. Hot air oven (s) different range of minimum required area is 800 temperature/vacuum oven. functioning of laborator y List of equipment recommended is instruments or to enable the given below: performance of special tests such as sterility tests and microbiological CHEMISTRY SECTION tests. Air conditioner. Electronic Balance. Spectro-Photometer. Dehumidifier (where necessary). U. Water supply demineralised employed with him as experts. time to time whether the space 6. Botany. 2 years for carrying out tests or 24. Unani or Pharmacist who shall 18. Heating mantle (4) or as required. Refrigerator. (ii) 9. (vi) Office-cum-Record Room. the drugs as per pharmacopoeial premises shall be air-conditioned so standards or other available as to maintain the accuracy and standards. 19. PH meter. be tested: 4. Provided further that viscometer). Wherever necessary. Moisture determination apparatus.I. Glass distillation apparatus/plant. quality and strength of Siddha and Unani drug warrants Ayurvedic. exchange equipment/distillation such as Chemist. (iv) 10. copoeias. Redwood adequate. LPG Gas Cylinder with burners. provided for (i) Chemistry. Melting point determination Provided that the approving apparatus.V. TLC apparatus with all accessories. Ayurved/Siddha/Unani/ 20. authority shall determine from 5. analysis as per the Ayurvedic. Siddha and Unani. the nature and number of 3. expert in Ayurveda/Siddha/ 17. Tablet disintegration apparatus. SIDDHA AND UNANI MEDICINES 37 i) The premises where the tests are (c) The applicant shall provide carried out shall be well lighted and adequate equipments essential properly ventilated except where the for carrying out tests for identity. 1. Alcohol determination apparatus (ii) (a) The applicant shall provide complete set. detector. with experience for 23. Volatile oil determination apparatus. with proper partitions and 13. Muffle furnace. . ft. equivalent. Refractometer. Microbiology. of persons who may be 16. LEGAL STATUS OF AYURVEDIC. (iii) Ayurveda. Siddha and Unani pharma. 14. Pharmacognosy. sq. (b) The applicant shall provide list 15. Bachelor in Pharmacy from a 21.

Microscope (high power). Siddha and Unani application is made within six months drugs intended to be tested which shall of its expiry after the payment of the be adequate in the opinion of the additional inspection fee. 5. purity. shall be valid for a period of reagents.). of one of the experts stated in clause (b) of sub-rule (2) who shall be the PHARMACOGNOSY SECTION person-in-charge of testing and shall be 1. Unani drugs (with Reference samples) recognized under the provisions of the MICROBIOLOGY SECTION Act and rules made thereunder and such 1. Autoclave/Sterilizer. B. reagents. 6. Siddha and laboratories. the testing or analysis of the products glasswares. as the case may be. Occular Micrometer. identity. Hot plates. books of standard recognized under the 11. Laminar air flow bench (L. the approval approving authority. Hot air oven. Camera Lucida Prism type and (6) The applicant shall provide mirror type. Tablet dissolution tester. Chemical balance. be carried out under the active direction chemicals and glasswares. and Unani drugs. applied for. shall continue to be in force until orders (4) The testing of Ayurvedic. SIDDHA AND UNANI MEDICINES 28. Serological water bath. purity. Microslide cabinet.D. Duration of Approval. Incubator. Tablet friability tester. 3. issued by the applicant. for 29. Other related equipment and withdrawn.– Instruments like HPLC. be carried out by persons whose 7. (5) The testing of Ayurvedic.38 LEGAL STATUS OF AYURVEDIC. held responsible for the reports of test 2. for 5. Refrigerator. for the testing of which approval is Note.F. reference samples kept in the laboratory 2. Microscope binocular. three years from the date on which it is granted or renewed: (3) The applicant shall provide and Provided that if an application for maintain suitable equipment having the renewal of an approval in Form 40 regard to the nature and number of is made before its expiry or if the samples of Ayurvedic. Other related equipments. HPTLC. qualifications and experience of testing 8. Atomic Absorption spectrophotometer (7) The applicant shall provide list could be arranged by tie up with other of standard Ayurvedic. as may be required in connection with 14. 160C. Stage Micrometer.O. testing or analysis of the products of 4. in Form 42 unless sooner suspended or 9. quality and strength shall 30. thereunder and such books of reference 13. Dissecting Microscope. Siddha to the contrary are passed on the . Other related equipment. which approval is applied for. reagents.– An 7. provisions of the Act and the rules made 12. as the case may be. etc. Siddha 4. identity. and Unani drugs. approval granted in Form 41 or renewed 8.A. Microtome. Oven. sub-rule (2). LPG Cylinder with burners. 10. may be required in connection with the 3. Colony counter. quality and strength shall 6. are adequate as stated in clause (b) of 9. Aluminium slide trays. Plain incubator.

– An time to time report to the approving approval in Form 41 shall be subject to authority any changes in the person- the following conditions. I. The approved laboratory shall VI. if Act to enter with or without prior any as may be specified in the rules notice the premises where the made from time to time under testing is carried out and to inspect Chapter IVA of the Act of which the premises and the equipment the approving authority has given used for test and the testing the approved laboratory not less procedures employed. The approved laboratory shall years. Siddha and date of expiry is assigned. for a period of three VIII. The Institution granted approval Siddha and Unani drugs or the under this Part (hereinafter referred expert staff responsible for testing. In case any sample of Ayurvedic. SIDDHA AND UNANI MEDICINES 39 application and the approval shall be the purpose of ascertaining whether deemed to have expired if the the provisions of the Act and rules application for renewal is not made made thereunder have been within six months of expiry. protocols of tests showing the the approved laboratory shall furnish readings and calculation in such to the approving authority and the form as to be available for inspection licensing authority of the State and such records shall be retained where the manufacturer and/or in the case of substances for which sender of the Ayurvedic. The approved laboratory shall from 160D. comply with the provisions of the IV. information as they may require for . LEGAL STATUS OF AYURVEDIC. III. to as the approved laboratory) shall as the case may be. or renewal of approval. a copy of period of two years from such date the test report on the sample with of expiry and in the case of other the protocols of tests applied. quality and strength carried or analysis in Form 50. changes in the equipment used for ment as specified in rule 160 B. V. Siddha and Unani drugs and the Siddha and Unani drug is found on results thereof together with the test to be not of standard quality. and any material provide and maintain adequate staff alterations in the peremises or and adequate premises and equip. The approved laboratory shall allow Act and rules made thereunder and the Inspector appointed under this with such further requirements. Conditions of Approval. out on all samples of Ayurvedic. The approved laboratory shall been made since the date of last provide proper facilities for storage inspection made on behalf of the so as to preserve the properties of approving authority before the grant the samples to be tested by it. for a Unani drugs is located. the purposes of testing which have II. observed. namely:– in-charge of testing of Ayurvedic. VII. substances. furnish reports of the results of tests purity. The than four months’ notice. The approved laboratory shall to inspect the registers and records maintain an inspection book to maintained under these rules and enable the Inspector to record his shall supply to such Inspectors such impression or defects notices. laboratory shall allow the Inspectors IX. The approved laboratory shall maintain records of tests for identity.

– On an application and State Government for this purpose. approval. grant the approval to be carried out to be inspected jointly in Form 48.] laid down have been satisfied and .– Before an approval in Form rupees. Siddha and Unani conditions for grant of approval have drugs. whose so satisfied. af ter causing an equipment intended to be used for inspection to be made and if satisfied testing of drugs and verify into the that the conditions of the approval and professional qualifications of the expert the rules made under the Act have been staff who are or may be employed by complied with. within three months reasons for such rejection and of the of the date of the order of suspension conditions which shall be satisfied before or withdrawal. Report of Inspection. the approving who shall examine the premises and the authority shall. withdraw an approval granted 160G. if 48 is granted. is proposed been complied with. is categories of Ayurvedic. thereunder. it shall grant provision of the Act of the rules made approval in Form 48. 160F. after giving the approved forward to the approving authority a laboratory an opportunity to show cause detailed report of the results of the why such an order should not be passed. appeal to the State approval could be granted. (2) If the approving authority is not (2) any approved laboratory. inspection. if in his rules made under the Act have been opinion the approved laboratory had complied with and that the conditions failed to comply with any of the of the approval and the rules made under conditions of the approval or with any the Act have been observed. the approving authority after causing a further inspection to be shall cause the laboratory at which the made and after being satisfied that the testing of Ayurvedic. Government which shall dispose of the appeal in consultation with a panel of 160H. shall issue a certificate the laboratory. Procedure of Approving under this Part or suspend it for such Authority.– (1) The approving Government as stated in rule 160E shall authority may.40 LEGAL STATUS OF AYURVEDIC. may. SIDDHA AND UNANI MEDICINES 160E. Renewal. Withdrawal and Suspension of Inspectors appointed by the Central Approvals. by an order in writing stating the reasons therefore. by the Inspectors appointed or designated by the Central Government 160I. it shall reject the application approval has been suspended or and shall inform the applicant of the withdrawn. Siddha and satisfied that the requirements of the Unani drugs to which it relates. as the case may be. the approving authority may.– The 160J. being made for renewal. Application after Rejection. if respect of testing of some of the any.– (1) If the approving period as it thinks fit either wholly or in authority after such further enquiry.– competent persons appointed by the If within a period of six months from Department of Indian Systems of the rejection of an application for Medicine and Homoeopathy. the applicant informs the Government of India in this behalf and approving authority that the conditions notified in the Official Gazette. Inspection before Grant of deposits inspection fee of two thousand Approval. as it may consider necessary. of renewal in Form 49.

. the ingredients contained in the medicine figure representing the is large and cannot be accommodated manufacturing licence number being on the label. iv) The number of the licence under Provided that if the list of which the drug is manufactured. Act. namely: conspicuously displayed on the label of i) The name of the drug. PACKING AND PART XVII LIMIT OF ALCOHOL IN] AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS 161. the following particulars “Lot” or any distinguishing prefix. No’ or “M.] v) A distinctive batch number.” or “Batch” (3) Subject to the other provisions or “Lot Number” or Lot No.]– (1) There shall be container is packed.L” the label. the same may be printed preceded by the words separately and enclosed with the packing ‘Manufacturing Licence Number’ of and reference be made to this effect on Mfg Lic. the number by reference to internal use made up ready for the which details of manufacture of the treatment of human ailments shall. measure therein and a reference to the method of number as the case may be. the figure representing to be taken under medical supervision’ the batch number being preceded both English and Hindi languages. as are expressed in metric system. For this indelible ink and shall appear in a purpose the date of manufacture conspicuous manner on the label of the shall be the date of completion of innermost container of any Ayurvedic the final products. [LABELLING. or the date of (including Siddha) or Unani drug and bottling or packing for issue. shall be either printed or written in vi) The date of manufacture. by the words “batch No. that is (2) The container of a medicine for to say. The of preparation thereof as detailed in the weight and volume shall be standard text and adikarana. the true list of all the ingredients books included in the First Schedule used in the manufacture of the of the Act. packing and limit on any other covering in which the of alcohol. if it particular batch from which the is made up from a substance specified substance in the container is taken in Schedule E(1). [Labelling.” or of these rules. For this the container or package of an purpose the name shall be the same Ayurvedic (including Siddha) or Unani as mentioned in the authoritative drug. be labelled are recorded and are available for conspicuously with the words ‘Caution: inspection. prescribed in the authoritative books iii) The name and address of the specified in the First Schedule of the manufacturer. preparation together with the quantity ii) A correct statement of the net of each of the ingredients incorporated content in terms of weight.

– (1) Labels and packages Siddha medicine” or Unani or containers of Ayurvedic. Exemption in labelling and if the medicine is for external packing provisions for export of application. (4) Nothing in these rules shall be alteration. transport or a) the name and address of the delivery. the drug content size of Schedule or Schedule E-(I). while complying with is packed and on every other covering labeling provisions under clauses (i) in which that container is packed. No. along with date i) Kapur Asava 15 ml. Unani drugs for export may be adapted viii) The words “FOR EXTERNAL to meet the specific requirements of the USE ONLY” if the medicine is for law of the country to which the said external application. 16% 120 ml (2) The provisions of Rule 161 shall drakshasava not apply to a medicine made up “ready for treatment”. x) (b) Preparations containing self. which is supplied on the deemed to require the labeling of any prescription of registered medical transparent cover or of any wrapper. the labels on packages or v/v) containers shall bear a code number as i) Mritsanjivani 16% 30 ml approved by the licensing Authority Sura mentioned in Rule 152. manufacturer and the number of licence under which the drug has Sl. Not to be sold” which shall Unani drug (Single or compound be overprinted. Siddha and medicine” as the case may be. or without. for “Best for use before. if required by the iii) Margamadasava 15 ml. Siddha and sample. practitioner if the medicine is labelled case or other covering used solely for with the following particulars namely :- the purpose of packing. f) FOR EXPORT: generated alcohol. is required of alcohol packing by the consignee to be not labelled with (Ethyl the name and address of the alcohol manufacturer. 161-A.42 LEGAL STATUS OF AYURVEDIC. formulations) x) (a) Preparation (Asavas) with high b) the name. ii) Maha. Name of the drug Maximum been manufactured. size of c) batch or lot number. address of the content of alcohol as base. drug is to be exported. Provided that where Ayurvedic. e) main ingredients. Name of Maximum Maximum drug not classified under the First No. packing d) date of manufacture. suppliers.” ii) Ahiphenasava 15 ml. Ayurvedic (including Siddha) and . importing country. SIDDHA AND UNANI MEDICINES vii) The words “Ayurvedic medicine” or Unani drugs. Siddha and Unani Single or compound Sl. to (viii) further bear on the label of namely: the container the words “Physician’s a) name of the Ayurvedic. whether after. but the following ix) Every drug intended for distribution particulars shall appear in conspicuous to the medical profession as a free position on the container in which drug sample shall. b) the words “For External Use Only”.

1970 (84 of 1970) B. or enforcement of provisions of all premises licensed for Chapter IV-A of the Drugs & manufacture to Ayurvedic (including Cosmetics Act.] license and the provisions of the Act and the rules made thereunder are 163. Procedure for Dispatch of being observed. 1940 and rules made Siddha) or Unani drugs within the thereunder or teaching/research on area allotted to him and to satisfy clinical practice of Ayurveda/Siddha/ himself that the conditions of the Unani System. Duties of Inspectors specially qualifications as per Schedule II of authorized to inspect the Indian Medicine Central Council Manufacture of Ayurvedic (including Act.– Subject to (Ayur veda) of a recognized the instruction of the controlling University. Sample to Government Analyst and ii) to sent forthwith to the controlling its Receipt by the Government authority after each inspection a Analyst.– (1) Samples for test or detailed report indicating whether analysis shall be sent to the Government or not the conditions of the licence Analyst by registered post or by hand in and the provisions of the Act and asealed package enclosed together with the rules made thereunder are being a memorandum in form 18-A in an outer observed. cover addressed to the Government iii) to take samples of the drugs Analyst. Siddha and Unani Drugs:– an inspector. manufactured on the premises and (2) The package as well as the outer send them for test or analysis in cover shall be marked with accordance with these rules. the Government Analyst a) The Ayur vedic/Siddha/Unani or an Officer authorised by him writing . Qualifications for State Drug Government Analyst Licencing Authority for Licensing of (4) On receipt of the package from Ayurveda.Pharma Siddha) or Unani Drugs. seal the package shall be sent by registered post or by hand to the 162-A. distinguishing number. Government Analysts and Inspectors PART XVIII for Ayurvedic (including Siddha) or Unani Drugs 162. authority. iv) to institute prosecutions in respect (3) A copy of the memorandum and of violation of the Act and the rules specimen impression of the seal used to made thereunder. Siddha and Unani drugs i) to inspect not less than twice a year. it shall be the duty of an b) At least 5 years experience in the Inspector authorized to inspect the Ayur veda/Siddha/Unani drug manufacture of Ayurvedic (including manufacturing or testing of Siddha) or Unani drugs:– Ayurvedic.

one copy of the results of Drug Laborator y in respect of the test or analysis shall be supplied Ayurvedic. seals on package.– After test or analysis.44 LEGAL STATUS OF AYURVEDIC. the Siddha or Unani systems of result of the test or analysis. Recording of Condition of (2) of section 11. for the (3) A copy of the memorandum in Ayurveda. Director. (4) to maintain reference museum and Pharmacopoeial laboratory for Indian herbarium for the drugs used in Medicine. Functions. Director in respect of the said drugs “Pharmacopoeial Laboratory for shall be exercised by the Director of the Indian Medicines to functions as said laboratory. Siddha and sent simultaneously to the controlling Unani medicine.A be carried out at the Pharmacopoeial copy of the result in Form 13A shall be Laboratory for Ayurvedic. (Uttar authority and to the Drugs Controller. standardized methods. system. The functions of the Central completed. Siddha and 163A.– On receipt of the packet. of the be opened by an officer authorized in Act. shall be marked with a amendments along with distinguishing number. Siddha and Unani (ASU) condition of the seal on the packet. Siddha and Unani drugs. (1) to develop Pharmacopoeial (2) The packet as well as the outer standards and draft monographs and cover. (5) After the test or analysis has been 163-B. who shall record the Ayurveda. SIDDHA AND UNANI MEDICINES in this behalf shall open the package may be entrusted to it by the and shall also record the condition of Government of India. Pharmacopoeial Its functions shall be:– Laboratory for Indian Medicine. (5) to run a training centre for quality 163-E. sent separately by registered post to the Siddha and Unani drugs. Ayurvedic. or under sub. Form 1A and a specimen impression of (2) to act as Central Appellate Drug the seal used to seal the packet shall be Laboratory for testing of Ayurveda.– The Pharmaco. or Analysis. Dispatch of Samples for Test Ayurveda. it shall section (4) of section 25. Pradesh) and the functions of the India. to the Director. Central Drugs Laboratory for the purpose of testing or analysis of 163-C. Pharmacopoeial Laboratory (3) to analyse or test such samples of for Indian Medicine. Siddha and Unani drugs shall forthwith to the sender in form 13A.– (1) Samples for testing or analysis of Ayurveda. as may be sent to it under sub-section 163-D. in an outer cover addressed Unani Drugs. Seals. Siddha and Unani drugs”. enclosed with a Drugs Laboratory for the purpose of memorandum in Form 1A specified in testing or analysis Ayurveda. Ghaziabad. writing on that behalf by the Director. with full protocols of the test applied. analysis. (6) to carry out such other duties as shall be supplied forthwith to the sender . Siddha and Unani drugs. Siddha and Schedule A. together medicines. Unani drugs under Sub-section (2) of poeial Laboratory for Indian Medicine Section 11 be sent by registered post in at Ghaziabad shall function as a Central a sealed packet. Report of result of test or control methods in the Ayurveda.

– The fees for test and Government or (iii) the head of an analysis shall be as specified in Schedule institution specially approved for the B-1. or if head of an Institution or testing no such pharmacopoeia are available or laboratory approved for the purpose if no tests are specified in such by the appointing authority [or has pharmacopoeias such tests as the completed two years training on Government Analyst may employ. b) possesses a post-graduate degree in Medicine or Science or Pharmacy 165. SIDDHA AND UNANI MEDICINES 45 in Form 2A of as specified in the said laboratory under the control of (i) a schedule. purpose by the appointing authority. as the case may Associate ship Diploma of the be conferred by a University a State Institution of Chemists (India) Government or Statutory Faculties. Qualifications of Government of Pharmaceutical Chemistry of a Analyst. for such purpose] or possesses the Siddha or Unani system. LEGAL STATUS OF AYURVEDIC. in Central determine whether the drug contains Drugs Laboratory].– The method of test or purpose] and has had not less than analysis to be employed in relation to five years’ training on testing of an Ayurvedic (including Siddha) or drugs in a laboratory under the Unani drugs shall be such as may be control of (i) a Government Analyst specified in the Ayurvedic (including appointed under the Act. as the case may subjects and has had after obtaining be. such testing of drugs.– Rule 44. or (ii) the Siddha) or Unani Pharmacopoeia. Signature on Certificates. Method of Test or Analysis to has an equivalent qualification be Employed in Relation to recognized and notified by the Ayurvedic (including Siddha) or Central Government for such Unani Drugs.” Chemistr y of a [University established in India by the law or 164. Fees. including items tests being scientifically established to stated in Schedule C. or the ingredients as stated on the label. obtained by passing the said Councils and Boards of Indian Systems examination with ‘Analysis of Drugs of Medicine recognized by the Central and Pharmaceuticals’ as one of the or State Government. 163-G.– A person who is appointed a [University established in India by Government Analyst under Section 33 the law or has an equivalent – F of the Act shall be a person qualification recognized and possessing the qualifications prescribed notified by the Central Government in Rule 44 or a degree in Ayurveda. shall be signed by the shall be a person who:– Director or by an officer authorized by a) is a graduate in Medicine or Science the Central Government to sign such or Pharmacy or Pharmaceutical certificates.– A person appointed as the Pharmacopoeial Laboratory for a Government Analyst under the Act Indian Medicine. Qualifications of Govern- Certificates issued under these rules by ment Analyst. for this purpose and has had not less the said post-graduate degree or than three years post graduate diploma not less than three Years’ experience in the analysis of drugs in a experience in the testing of drugs . or (ii) a Chemical Examiner to 163-F. Government Analyst appointed under the Act.

as may be considered necessary.] (ii) for a period of four years from the 166. i) the purpose of examination of items Toxoid and Vaccines and Diagnostic in Schedule C. furnish reports of the results or test The persons so appointed may. SIDDHA AND UNANI MEDICINES in a laboratory under the control of the appointing authority so desires. pharmacy and has had not less than five Pharmacy should have experience years’ experience in the standardization or training in testing of said items of biological products or a person in an institution or laboratory holding a post-graduate degree in approved by the appointing Veterinary Science. general science.– date on which Chapter IV of the (1) The Government Analyst shall Act takes effect in the States. or (ii) the head or an of the said period of four years. including items Government Analyst for any stated in Schedule C.46 LEGAL STATUS OF AYURVEDIC. Microbiology. may be sent to him by Inspectors or any subject to such further training. in Central Drugs Laboratory. authority for a period of not less or medicine or Pharmacy or than six months. Duties of Government Analyst. Institution of testing laboratory (iii)no person who is engaged directly approved for the purpose by the or indirectly in any trade or business appointing authority [or has connected with the manufacture of completed two years’ training on drugs shall be appointed as a testing of drugs. Physiology. by the Central Government or a State a reasonable guarantee of adequate Government under the provisions of knowledge and competence may be Chapter IV-A of the Act and shall appointed as Government Analysts. or General Science. or Medicine. the person (ia) the persons appointed under clause appointed shall be a person who is a (a) or (b) and having degree in graduate in Veterinary Science. if or analysis in accordance with these . if other persons or authority authorized any. Pharmaceutical Chemistry with an (ib)the person appointed under clause experience of not less than three years (a) or (b) but not having degree in in the standardization of biological the above subject should have products: experience or training in testing of Provided also that persons. analyse or test or cause to be analysed persons. whose training and or tested such sample of Ayurvedic experience are regarded by the (including Siddha) or Unani drugs as appointing authority as affording. (i) a Government Analyst appointed continue in service after the expiry under the Act. already the said Schedule C drugs for a appointed as Government Analysts may period of not less than three years continue to remain in service. approved by the appointing notwithstanding the fact that they do authority or have completed two not fulfill the qualifications as laid down years training on testing of drugs in clause (a) clause (b) or the preceding including item stated in Schedule C proviso. if the in an institution or laboratory appointing authority so desires. in Central area: Drugs Laboratory]: Provided fur ther that for the Provided that – purpose of examination of Antisera.– Antigens for Veterinary use. or medicine or Pharmacology.

established in India by law: Provided that only those Inspectors– 167.]} Government for this purpose). as the case may be. granted by a State Government qualification shall not apply to persons or an Institution recognized by the appointed as Inspectors on or before Central Government or a State the 18th day of October. Qualification of Inspector. as the case may requirement as to the academic be. .– (2) A Government Analyst A person who is appointed an Inspector appointed under Section 33 F shall from under the Act shall be a person who has time to time forward to the Government a degree in Pharmacy or Pharmaceutical reports giving the results of analytical Sciences or Medicine with specialization work and research with a view to their in Clinical Pharmacology or publication at the discretion of the Microbiology from a University Government. or or b) has degree in Ayurvedic or Siddha iii) who have gained experience of not or Unani system or a degree in less than three years in the Ayurveda Pharmacy. Council or Board of Indian their services as Drugs Inspectors. {49. Siddha [Provided fur ther that the or Unani System. or mentioned in Schedule C:] c) has a diploma in Ayurveda. LEGAL STATUS OF AYURVEDIC. SIDDHA AND UNANI MEDICINES 47 rules. conferred by a University or a any of the substances specified in State Government or a Statutory Schedule C during the tenure of Faculty. Systems of Medicine recognized by shall be authorized to inspect the the Central Government or the State manufacture of the substances Government for this purpose. 1993. or a) has the qualifications laid down ii) who have not less than 18 months’ under Rule 49 and shall have experience in testing of at least one undergone practical training in the of the substances in Schedule C in manufacture of Ayur vedic a laboratory approved for this (including Siddha) or Unani drug. Qualifications of Inspectors.– A i) who have not less than 18 months’ person who is appointed an Inspector experience in the manufacture of at under Section 33-G shall be a person least one of the substances specified who – in Schedule C. as the case may inspection of firm manufacturing be. purpose by the licensing authority.

Carmellose Sodium IP 12. Calcium Phosphate Dibasic IP 9.– Permitted Excipients. [***] drugs included in The standards for identity.No. Carnauba Wax IP 13. National Formulary (USNF) and others as mentioned in column (3) of the Table. i. preservatives. Siddha and Unani Drugs. Additives: 1. Class of Drugs Standards to be complied with 1. Calcium Phosphate Tribasic IP 10. British Pharmacopoeia (BP). namely: Sl. 2. Citric acid & its salts PFA 16. United States. Beeswax IP 6. Agar PFA 3. 169. additives. Bentonite IP 7. antioxidants. flavoring agents. Carbomer IP 11. Asavas abd Aristas The upper limit of alcohol as self generated alcohol should not exceed 12% v/v excepting those that are otherwise notified by the Central Government from time to time. Activated Charcoal IP 2. Siddha and Unani Drugs 168. Purity and Ayurvedic Pharmacopoeia strength as given in the editions of Ayurvedic Pharrmacopoeia of India for the time being in force. Arachis Oil PFA 5. Permitted Excipients Reference Standard/Grade A. Colloidal Silicon Dioxide IP . colouring agents. Standards to be complied with in manufacture for sale or for distribution of Ayurvedic. Indian Pharmacopoeia (IP).e.No. Cellulose & its derivatives IP 14. Permitted Excipents.PART XIX Standards of Ayurvedic. alternate sweeteners specified in column 2) of the Table below are permitted in Ayurveda or Siddha or Unani drugs as per reference standard or grade under the prevention of Food Adulteration Act (PFA). Alginic Acid & its salts PFA 4. Cetocetyl alcohol IP 15. Calcium Carbonate PFA 8.- Sl.

Guar Gum PFA 24. Polysorbates IP 53. Magnesium aluminium silicate BP 39. LEGAL STATUS OF AYURVEDIC. Polyvinyl pyrollidone IP 56. Hard Paraffin IP 26. Light Mineral Oil IP 36. Light magnesium Carbonate IP 35. Polymethacylate IP 52. Shellac IP 60. Sodium Silicate IP . Pectic Enzyme In house specification 48. Polyvinal acetate phthalate IP 54. Dextrin & its derivatives PFA/IP 18. Propylene Glycol IP 59. Lactose IP 33. Liquid Glucose PFA 37. Sodium Chloride PFA 63.No. Sodium Bicarbonate IP 62. Icing Sugar PFA 28. Mannitol IP 45. Glycerin IP 23. Lecithin/Soya Lecithin USNF 34. Permitted Excipients Reference Standard/Grade 17. Magnesium Oxide IP 41. Microcrystalline Wax IP 47. Pectic Enzyme PFA 49. Gum Acacia PFA 25. Invert Sugar Syrup BP 29. Malic Acid PFA 42. Skimmed Milk Powder PFA 61. Malt Extract IP 43. Glucose PFA 22. Magnesium Carbonate IP 40. Polyvinyl alcohol IP 55. Isopropyl myristate IP 30. Kokam Butter PFA 32. Sodium Lauryl Sulphate IP 66. Poloxamer USNF 50. Sodium Hydroxide IP 65. Hydrogenated Vegetable Oil PFA 27. Sodium Edeate PFA 64. Potassium Bicarbonate IP 57. Maltodextrin USNF 44. Dextrose PFA 19. Povidone & its derivatives IP 58. SIDDHA AND UNANI MEDICINES 49 Sl. Liquid Paraffin IP 38. Gelatin IP 21. Isopropyl palmitate BP 31. Emulsifying Anionic Wax IP 20. Polyethylene Glycol IP 51. Methcrylic acid ethylacrylate USNF 46.

Propyl parabe & its salts PFA 14. Sodium Starch Glycollate IP 68. Propionic acid & its salts PFA 13. Yellow petroleum wax IP 86. Butylated hydroxyl anisole PFA 3. Preservatives: 1. Permitted Excipients Reference Standard/Grade 67. Flavouring agents As permitted under Fruit Product Order and PFA Act. Colouring agents: As permitted under rule 127 of Drugs and Cosmetics Rules 1945 E. Ethyl paraben BP 9. Cetrimide IP 8. Stearic Acid & its salts IP 74. Starch & its derivatives IP 73. Zinc oxide IP B. Xanthan Gum USNF 82. Tartaric Acid & its salt PFA 77. Potassium metabisulphite PFA 6. Acetic acid PFA 2. Butylated hydroxyl toluene PFA 4. Alternate Sweeteners: As permitted under Fruits Product Order. F. Benzethonium chloride IP 4. . Sorbitan Esters IP 71. Antioxidants: 1. Yeast PFA 84.50 LEGAL STATUS OF AYURVEDIC. Rule 163. Imid urea In house specification 10. SIDDHA AND UNANI MEDICINES Sl. Sorbic acid & its salts PFA C. Sorbitol IP 72. Bronopol BP 6. Sucrose IP 75. Sodium Stearyl Fumarate IP 69. Benzoic acid & its salts PFA 5. White petroleum jelly IP 81. Sodium metabisulphite PFA D. Wax microfine IP 79. Yellow petroleum jelly IP 85. Xylitol USNF 83. Phenyl mercuric nitrate IP 12. Soft Paraffin IP 70. Benzalkonium chloride IP 3. Ascorbic acid & its salts & esters PFA 2. Wax non-ionic emulsigying IP 80. Talc IP 76. Methyl Paraben & its salts PFA 11. Butyl paraben BP 7. Gallic acid esters PFA 5. Titanium Dioxide IP 78.No.

............................................................... 2.................................... I send herewith under the provisions of section 11(2)/section 33-H of the Drugs and Cosmetics Act................................ Matter on which opinion is required ... A fee of Rs........ Magistrate/Authorized Signatory ...................... for test or analysis and request that a report of the result of the test or analysis may be supplied to this Court...................................... has been deposited in Court.......... 5.............................. 1940.................................. sample(s) of a drug purporting to be .......................... .................................... Pharmacopoeial Laboratory for Indian Medicine.......... . The Distinguishing number on the packet is . Date.............. (Full name........ 3................................................................................. FORM-1A SCHEDULE-A Memorandum to the Pharmacopoeial Laboratory for Indian Medicine (PLIM) From................. To the Director.................................................................. Designation & Postal address of the sender) Serial No.............................. Particulars of offence alleged ....................................... 4..........................

.............. The condition of the seals on the packet on receipt was as follows:– *3............ In the opinion of the undersigned the sample is of standard quality as defined in the Drugs and Cosmetics Act.... .. received on .................... Name & Address of the Laboratory..... with memorandum No..... 1940........ from ...... bearing number .... or rules thereunder for the reasons given below......... dated .................... or rules thereunder for the reasons given below....... has been tested/analyzed and that the result of such test/analysis is as stated below................. purporting to be a sample of ..............52 LEGAL STATUS OF AYURVEDIC............. Or In the opinion of the undersigned the sample is not of standard quality as defined in the Drugs and Cosmetics Act....................................................... SIDDHA AND UNANI MEDICINES FORM-2A Certificate of Test or Analysis from the Pharmacopoeial Laboratory for Indian Medicine or Government Analyst Certified that the samples...... 2... Note: *delete whichever is not applicable” (Signature of the Analyst Person-in-Charge of testing) Date Place Name & Designation & Seal................... ................... 1940............

.................... and e-mail no........................................ 1945 I/we ...................... Issued ...... signed by the manufacturer as required by rule 24 of the Drugs and Cosmetics Rule 1945..... through M/s ........ (full address........................................................ enclose herewith a copy of Registration Certificate concerning the drug to be imported in India................................... fax number and e-mail address) hereby apply for a licence to import drugs specified below manufactured by M/s.................................................... 6.......................... with telephone number.. A fee of ..................... I/we...... (name and full address) .............................................. A copy of the said licence is enclosed...... Dated .. enclose herewith an undertaking in Form 9 dated .................. ... SIDDHA AND UNANI MEDICINES 53 FORM-8 Application for Licence to Import Drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules............................................................................. valid upto ........) 2..................................... (full address with telephone number............. fax...... I/we ... I/we ... Names of the drugs to be imported: i) ii) iii) 3..... issued under Form 41 of the rules........................................................... hold a valid wholesale licence for sale or distribution of drugs or valid licence to manufacture drugs... has been credited to Government under the Head of Account “0210-Medical and Public Health................. 5.................. 104- Fees and Fines” under the Drugs ........................... . 04-Public Health..... LEGAL STATUS OF AYURVEDIC..... vide Registration Certificate No.... 4..................................... under the provisions of the Act and rules made thereunder....

.... intends to apply for a licence under the Drugs manufactured by us............ we .......... Designation .....54 LEGAL STATUS OF AYURVEDIC..... 4) we shall comply with the provisions of Part IX of the Drug and Cosmetics Rules..... Signature .................. 6) we shall comply with such further requirement.. and we shall from time to time report any change of premises on which manufacture will be carried on and in cases where manufacture is carried on in more than one factory any change in the distribution of functions between the factories... hereby give this undertaking that for the duration of the said licence:– 1) the said application shall be our agent for the import into India........................ SIDDHA AND UNANI MEDICINES FORM-9 Form of Undretaking to Accompany an Application for an Import Licence Whereas ................. of ........................... 1945............................ 2) we shall comply with the conditions imposed on a licence by [Rule 74 and 78] of the Drugs and Cosmetics Rules............................... 1945.. Date .. Seal/Stamp of manufacturer or on behalf of the manufacturer . by the Central Government under the Act and of which the licensing authority has given to the licensee not less than four months notice.................................................. Name .. of ....... 5) every drug manufactured by us for import under licence into India shall as regards strength....... 1945....................... Particulars of premises where manufacture is carried on............. quality and purity conform with the provisions of Chapter III of the Drugs and Cosmetics Rules... 3) we declare that we are carrying on the manufacture of the drugs mentioned in this undertaking at the premises specified below. if any........... as may be specified by Rules......

............ Names of drugs to be imported: Place . This licence shall be in force from ... Licensing Authority Seal/Stamp ........ LEGAL STATUS OF AYURVEDIC. ..................................... to ........... .................... (name and full address) and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence........... the drugs specified to import into India during the period for which this licence is in force....................................................................... 1945 Licence Number ....................................... 2.................. manufactured by M/s. Date........... SIDDHA AND UNANI MEDICINES 55 FORM-10 Licence to Import Drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules..................... unless it is sooner suspended or cancelled under the said rules.. 1................. is hereby licensed to import into India during the period for which this licence is in force.. (Name and full address of the importer) ............... 3................................ Date ...................... the drugs specified below................ ...................

.. is hereby licensed to import from ......... unless previously suspended or revoked.............................................. SIDDHA AND UNANI MEDICINES FORM-11 Licence to Import Drugs for the Purpose of Examination.. 3............ Test or Analysis I...........56 LEGAL STATUS OF AYURVEDIC.................. of ...... Or in such other places as the licensing authority may from time to time authorize.............. Licensing Authority ... This licence shall........... test or analysis at ..... the drugs specified below for the purposes of examination.. 1940............. ...... This license is subject to the conditions prescribed in the Rules under the Drugs and Cosmetics Act......... be in force for a periods of one year from the date specified below:– Names of drugs Quantities which may be imported Date ............ 2............................

................ ..... 3............. The licence shall be displayed in the office of the Medical Superintendent of Government Hospital/Head of Institution of Autonomous Medical Institution............... ....... Designation . by a registered pharmacist giving the full name(s) and address (es) of the patients........... diagnosis......... total quantity of drugs imported and issued...... on demand by an Inspector appointed under the Act............. This licence shall....... The drugs under this licence shall be exclusively used for the treatment of patients..................... 3.. (name and full address) the drugs specified below for the purpose of treatment of patients for the disease (name of the disease) ... or in such other places as the licensing authority may from time to time authorize.... dosage schedule.......... Seal/Stamp 1. Names of drugs to be imported: Names of drugs Quantity which may be imported Place……………… LICENSING AUTHORITY Date ..... Date . Dr.............. ............... at ........ ........................... LEGAL STATUS OF AYURVEDIC.............................. SIDDHA AND UNANI MEDICINES 57 FORM-11A Licence to Import Drugs by a Government Hospital or Autonomous Medical Instituion for the Treatment of Patients Licence No...... 2..... 2.. be in force for a period of one year from the date of issue specified above.. is hereby licensed to import from M/s... and a record shall be maintained in this regard..... (Name of College/Hospital/Autonomous Institution) ................... and shall be countersigned by the Medical Superintendent of the Government Hospital of Head of the Autonomous Medical Institution which shall be produced.................... The licencee shall store the drugs imported under this licence under proper storage conditions........ unless previously suspended or revoked..................

............................................................... .................58 LEGAL STATUS OF AYURVEDIC........................................................... Dated ............. 04-Public Health.. Test or Analysis I......................... (attached in original)] Name of drugs and classes of drugs Quantities Signature ... test or analysis at .............. has been credited to Government under the Head of Account “0210-Medical and Public Health.............. resident of ........................................ I attach a prescription from a registered medical practitioner in regard to the need for the said drugs.................................... 104-Fees and Fines under the Drugs and Cosmetics Rules..... by occupation .... from .... ...................................................................................... resident of ... Quantities Date ................................... [A fee of rupees ... Signature .. and I undertake to comply with the condition applicable to the licence................. 1945-Central vide Challan No............. hereby apply for a licence to import the drugs specified below for the purpose for the purpose of examination.................................................................................] ....... SIDDHA AND UNANI MEDICINES FORM-12 Application for Licence to Import Drugs for Purpose of Examination................... ....... FORM-12A Application for the Issue of a Permit to Import Small Quantities of Drugs for Personal Use I.................................................... by occupation ............. hereby apply for a permit to import the drugs specified below for personal use from .......

...... 4........................................ Name of ingredients purporting to have been used in the preparation of the sample .......................... Date ................................................................ Details of portion of sample or container with name of ingredients from which it is claimed to be made........................................... SIDDHA AND UNANI MEDICINES 59 FORM-13A Certificate of Tests or Analysis by Government Analyst under Section 33-H of the Drugs and Cosmetics Act....................................................... From To The Government Analyst The portion of sample/container described below is sent herewith for test of analysis under the provisions of Section 33-H of the Drugs and Cosmetic Act................................ 3................................. Serial No............................. 7........ 1940........................................................ 1940 1........ Condition of seal on the package ............. Date of receipt ............................................................................................. The portion of sample/container has been marked by me with the following mark.... 6.................. Name of Inspector from whom received ..... Government Analyst .................................................. Results of test or analysis ................... 2........................................... LEGAL STATUS OF AYURVEDIC...... Date ............. FORM-18A Memorandum to Government Analyst Serial No.... Inspector......... 5.........] ............................................................ and date of Inspector’s memorandum .......................................................................................................... Number of sample .................

............................................................................. SIDDHA AND UNANI MEDICINES FORM-24D Application for the Grant/Renewal of Licence to Manufacture for Sale of Ayurvedic/Siddha or Unani Drugs 1..............60 LEGAL STATUS OF AYURVEDIC........ of ....... 4........... (applicant) Note: The application should be accompanied by a plan of the premises..... hereby apply for the grant renewal of a licence to manufacture Ayurvedic (including Siddha) or Unani drugs on the premises situated at ............................... 2............ I/We ..... and the relevant Treasury Challan in enclosed herewith...... Date ......................... Names qualifications and experience of technical staff employed for manufacture and testing of Ayurvedic (including Siddha) or Unani drugs ... has been credited to the Government under the head of account ......................................... Signature ............... Names of drugs to be manufactured (with details)..................................... A fee of rupees .............. ........ 3..................

.. 5.......... (c) Specimen of labels cartons of the drugs proposed to be manufactured.. Names of drugs to be manufactured (with details).................................................. and the relevant Treasury Challan is enclosed herewith...................... 4.................... A fee of Rs.......................................................... qualifications and experience of technical stall actually connected with the manufacture and testing of Ayurvedic (including Siddha) or Unani drugs in the manufacturing premises......... 2... has been credited to Government under the head of account ............. C/o ........... of ...... (applicant) ... SIDDHA AND UNANI MEDICINES 61 FORM-24E Application for Grant or Renewal of a Loan Licence to Manufacture for Sale Ayurvedic (including Siddha) or Unani Drugs 1... (a) A true copy of a letter from me/us to the manufacturing concern whose manufacturing capacity is intended to be utilized by me/us........... The Names....................................... I/We enclose.. 3..... equipment and premises for the manufacture of each item required by me/us and that they shall maintain the registers of raw materials and finished products separately in this behalf. (b) A true copy of a letter from the manufacturing concern that they agree to lend the service of their competent technical staff.................. I/We .. LEGAL STATUS OF AYURVEDIC.................................. hereby apply for the grant renewal of a loan licence to manufacture Ayurvedic (including Siddha) or Unani Drugs on the premises situated at ........ Date ... Signature .........

........................ SIDDHA AND UNANI MEDICINES FORM-25D Licence to Manufacture for the Sale of Ayurvedic (including Siddha) or Unani Drugs No. ................................................................... under the direction and supervision of the following technical staff:– a) Technical staff (names)...... 2. b) Names of drugs (each item to be separately specified)................. is/are hereby licensed to manufacture the following Ayurvedic (including Siddha) or Unani drugs on the premises situated at .......... to ................. The licence shall be in force from ........................... Date of Issue .......... The licence is subject to the conditions stated below and to such other conditions as may be specified in the rules for the time being in force under the Drugs and Cosmetics Act 1940.............. Designation ...... Signature...... 3....... ........................................................................................... of licence........ 1......................62 LEGAL STATUS OF AYURVEDIC...

...... for the manufacture of Ayurvedic/Siddha or Unani drugs at the premises situated at ...................................... 3.............................................................................................. Certified that licence No................ has been renewed from .. under the direction and supervision of the following expert..................................... . 2.................. is hereby granted a loan licence to manufacture for sale Ayurvedic (including Siddha) and Unani drugs.................................................. to Shri/Messrs .. The licence shall be in force from ............................. The licence is subject to the conditions stated below and to such other conditions as may be specified to the conditions stated below and to such other conditions as may be specified in the rules for the time being in force under the Drugs and Cosmetics Act......................................................... to .. of ............. ............................................................................. 2.............. 1940............ technical staff: a) Technical Staff (Names) .............................. Signature ...... on the premises situated at .................... Date of Issue ............................... C/o ............................. Number of licence ................... Designation ....... granted on the ....................... Date ................. Names of technical staff .................... SIDDHA AND UNANI MEDICINES 63 FORM-25E Loan Licence to Manufacture for Sale Ayurvedic (including Siddha) or Unani Drugs 1.................. Names of drugs (each item to be separately specified....... 4.. Signature ................................. Designation ............................................................................ b) Name of drugs (each item to be separately specified) 3...... to ...... LEGAL STATUS OF AYURVEDIC........................ FORM-26D Certificate of Renewal of Licence to Manufacture for Sale Ayurvedic (including Siddha) or Unani Drugs 1....................

...... Names of technical staff ......................... Date ......... comply with the requirements of Good Manufacturing Practices of Ayurvedic- Siddha -Unani drugs as laid down in Schedule T of the Drugs and Cosmetic Rules....... 2............. Designation ................................ This certificate is valid for a period of three years............. of Good Manufacturing Practices (GMP) to Manufacturer of Ayurvedic (including Siddha) or Unani Drugs 1............. Licence No........ Date ................................... to .......... namely .................. Signature ............. to ............................................................................ for the manufacture of Ayurvedic/Siddha/Unani drugs at the premises situated at ................................. State .............. FORM-26E-1 Certificate................................... ................. SIDDHA AND UNANI MEDICINES FORM-26E Certificate of Renewal of Loan Licence to Manufacture for Sale Ayurvedic (including Siddha) or Unani Drugs 1.............................................................................................................................................................................. C/o ..................................... Date ...................... has been renewed from ............................ 1945..................................................... Signature ....64 LEGAL STATUS OF AYURVEDIC......... granted on the ..... situated at .......... Certified that manufacturing unit licensee............... Place ................. Certified that loan licence No...................................... Designation ........................

. Vartti 14.. Netrabindu (Aschyotan) 15... “I/We .... “Categories of Ayurvedic.. Nabeez...... Siddha and Unani drugs 1... Asava and Arista 1..... Satt.. Raughan 6..... quality and strength on the following categories of Ayurvedic. Zuroor.... Kvatha Curna-Kutinir Curanam 4. Siddha and Unani drugs other than those specified in the First Schedule to this Act for which testing will be carried-out: AYURVEDA AND SIDDHA UNANI 1... Churna-Curanam 7... Sayyal... Shiyaf 9... Siddha and Unani drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of Ayurvedic. Jawarish.. Majoon and its sub-categories:– Itrifal. Avaleha and Paka-llakarn 3. Dravaka-Tiravakam 9. LEGAL STATUS OF AYURVEDIC....... SIDDHA AND UNANI MEDICINES 65 FORM-47 Application for grant or renewal of approval for carrying out tests on Ayurvedic. Sharbat Sikanjabeen 15. Anjana-Kanmai 16...... Qurs (Tablet) .. Khal (Sirka) 2... Sunoon 4. Habb (Pill) 8. Siddha and Unani drugs or raw materials used in the manufacture thereof on behalf of licensee for manufacture for sale of Ayurvedic...... Guggulu 5. Siddha and Unani drugs.. Lepa-Pacai 12 Kushta 13. of .. Kajal 11.. Gutika-Kulikai 13... Khameera. Namak.... Qutoor (drops) 10.. Sufoof.... purity. Arq (Distillates) 16. 2.. Laooq..... Usara 12. Khar 5. Halwa 3... Kohal (Surma). Taila-Tailam 8.. Lavana-Uppu 10.. Ghrita-Ney 6.. Vati.. hereby apply for the grant/ renewal of approval for carrying out tests of identity. Arka-Tinir 2.. Joshanda (Single drugs) 14. Zimad 7. Kshara-Saram 11..

Karna Bindu (Ear drops) 38. SIDDHA AND UNANI MEDICINES 17.... Shamoom 28.. Vajoor (Throat pain) patent and Proprietary and Ayurvedic... Jauhar 25.66 LEGAL STATUS OF AYURVEDIC... Unani formulation 35....... Humool.. Single drugs: 34........ 2... Date . Qairooti 18....... Mandura-Atai Kutinir 22.. Signature ...... Ubtan........ Mazmazah (Mouth washer) 1. Siddha........... Capsule 29..... Parpati 19. Lashooq 32.... Nabati Advia 21.. Mazoogh 30.. Kshar Suta/Kshar Varti 33.... Bakhoor 20. Naswar 27. Maadni Advia 22.. Marham. Lauha 24. Sabagh a) Plant based b) Mineral based c) Metal based d) Animal based e) Synthetic f) Any other Ayurvedic... Haiwani Advia 24.. has been credited to Government under the head of account ... Ghaza.. Nashooq... Ointment-Kalimapu 30.... An inspection fee of rupees .... Bhasma-Parpam 21............... Nasya 36... qualifications and experience of experts employed for testing and the person-in-charge of testing. Gulqand 33........... Ajsad Advia 23.. Natool 26. Haqna 37.. Sattva-Sattu 17.... Fateela 34.. List of testing equipment provided. Rasayoga-Centuram 23.. Kvath Pravahi-Kutinir 26.... Phalavrti 31... Tablet-Mattirai 28... .... Names........ Panak (Syrup)-Manappaku 27. Dhoomravarti/Doopan 32. Any other dosage form of 39........ Swarasa (Fresh juice) 37.. Kupipakva Rasayana-Kuppi Centuram 18. I/We enclose a plan of the testing premises showing the location and area of the different sections thereof 4. Tila 31.. Pishti 20....... Pushp (Phool) 35 Capsule 36. Naurah 38......... Unani Drug 40.... Saoot (Nasal drops) 29. Siddha. Furzaja 19... Ghana Sattva 25. 3. Latookh 39...

........................... (experts) and ...................................................................................... 3............. Siddha and Unani drugs Number of approval and date of issue : 1................ SIDDHA AND UNANI MEDICINES 67 FORM-48 Approval for carrying out tests or analysis on Ayurvedic..... .... Siddha or Unani drugs and the raw materials used in the manufacture thereof on the premises situated at ...... Date ......................... to .. (person-in-charge).................................. quality and strength on the following categories of Ayurvedic.......................................... Signature .. ....................... Categories of Ayurvedic..... 2.............................. Place ......................................... The approval shall be in force from . Seal of state Licensing Authority ....................................................................................................................................................................................................... Names of experts employed for testing and the person-in-charge of testing ............................................................................................................................................. Siddha and Unani drugs: ................... for carrying out tests for identity..................................................................... purity.................. LEGAL STATUS OF AYURVEDIC.......... Designation .. 4...... The approval is subject to the conditions stated below and such other conditions as may be specified in the rules for the time being in force under the Act.... Siddha and Unani drugs or raw Materials used in the manufacture thereof on behalf of licensees for manufacture for sale of Ayurvedic............................... Approval is hereby granted to .......................................................

68 LEGAL STATUS OF AYURVEDIC. Full address of the Applicant . If the applicant wishes to undertake during the currency of the approval the testing of any other category of Ayurvedic. this approvel will be deemed to the item so endorsed. Siddha or Unani drugs it should apply to the approving authority for necessary endorsement asprovided in rule160A. Any change in the experts or in the person-in-charge of the testing shall be forthwith reported to the approving authority. This approval and any certificate of renewal in Form 42 shall be displayed in the approval premises and shall be produced at the request of the Inspectors appointed under the Act. 4. The applicant shall inform the approving authority in writing in the event of any change of the constitution of the laboratory operating under this Form. SIDDHA AND UNANI MEDICINES Condition of Approval 1. 2.. Where any change in the constitution of the laboratory takes place. the current approval shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless. in the meantime. a fresh approval has been taken from the approving authority in the name of the laboratory with the changed constitution. 3.

................................................................... Categories of Ayurvedic......................................................................... (experts) and ................................. Certified that approval number ............................ Siddha or Unani drugs 1................ Seal of state Licensing Authority .......................................... Names of experts and the person-in-charge testing ...... Designation ........................... Siddha or Unani drugs: ................... has been renewed from ....................................................................................... granted on the ............ Place ............................... Siddha or Unani drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of Ayurvedic..................................................................... (person-in-charge)......................................... SIDDHA AND UNANI MEDICINES 69 FORM-49 Certificate of renewal for carrying out tests or analysis on Ayurvedic........................ quality and strength on the following categories of Ayurvedic Siddha or Unani durgs and the raw materials used in the manufacture thereof at the premises situated at .. Signature .................................... (Date)................... ................ 2... ............................................. purity............................................................................ to ......................... day strength on the following carrying out tests of identity..................................... Date ............ LEGAL STATUS OF AYURVEDIC........................................

...... c) Batch size as represented by sample.............. 7............................................... b) Batch Number............................ the sample referred to above is of standard quality/is not of standard quality as defined in the Act or the rules made thereunder for the reasons given below ............... if any...........................70 LEGAL STATUS OF AYURVEDIC... 6.......... 5...................... Name & Address of the Laboratory .................... e) Date of expiry..... Siddha and Unani durg of raw material purporting to be contained in the sample..............................) Name & Designation & Seal ................................. (F.......................... Reference number and date of the letter from the manufacturer under which the same was forwarded......... Name of manufacture from whom sample received together with his manufacturing licence number under the Act or the rules made thereunder .. SIDDHA AND UNANI MEDICINES FORM-50 Report of Test or Analysis by Approved Laboratory 1...... Date of receipt of the sample..................... Results of test or analysis with protocols of test or analysis applied or as per Ayurvedic.. Date ................................................................................ No.............. d) Date of manufacture.... 3........ if any..... purity. quality and strength of Patent and Proprietary drugs....................................... Other specific tests for identity................... 2..... Detail of raw material of final product (in bulk finished pack) as obtained from the manufacturer: a) Original manufacture’s name in the case of raw materials and drugs repacked..................... (Signature of the Person-in-Charge of testing Place ........ Siddha or Unani Pharmacopoeial standards........ ...... Name of Ayurvedic................................ ........ Note: Final product includes repacked material................. Licence No.......... In the opinion of the undersigned............................................ 4.......

00 27. restricted to single drugs qualitative 1000.00 13. Siddha and Homoeopathy.00 (b) Sugar coated 200. Disintegration of tablets and capsules (a) Ordinary 100. iodine value.00 11. Microscopic examination of raw material of compounds 500.00 (c) Enteric coated 400.00 Note: Sample testing charges will be determined/revised by the Director or Government Analyst of the Pharmacopoeial Laboratory for Indian Medicine.T. Unani. as the case may be in consultation with Department of Ayurveda.L.00 16. Microbscopic examination of single drugs 250. ash content.00 25.00 total solids. Physiochemical Assays 300.00 3. Yoga. Atomic absorption Spectrophotometry for Hg.00 26. 500.00 4. Identification test for raw material of plant origin (other than assay of constituents) 125. Optical rotation 250. Determination of lethal doses LD 50 to 10 on Mice 2500. Disinfectants 1000. Other miscellaneous tests 1000. As.00 20.C. Gas liquid chromatography 1000. Cosmetics/tailas/creams 500. saponificaton value.00 12. Paper chromatography 250. Arsenic testing 250.00 7. Cd. Refractive Index 250.00 5. Ministry of Health and Family Welfare.Pb. 100. loss on drying etc. Abnormal toxicity of undue toxicity of safety test 750. Test for Sterility 250.00 17. Chemical test for each ingredient 500. Chemical identifications as per Pharmacopoeia 250.” .00 18.00 9.00 2.00 24.00 22. Tests other than assay (limit tests for impurities.) for each test 14.00 8. Limit test for drugs of chemical origin 150.00 10. acid value. Any other test requiring animal experimentation 500. Identification test for raw material of chemical origin (other than assay) 100.00 21.00 15. Fees for the Test or Analysis by SCHEDULE B-1 the Pharmaopoeial Laboratory for Indian Medicine (PLIM) or the Government Analyst Type of testing/analysis Cost of testing or analysis in Rupees 1. Column chromatography 2500.00 23. Microbiological assay 750.P.00 6. H.00 19. Thin layer chromatography 300.

SCHEDULE–E(I) List of Poisonous Substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine A. Ait. Karaveera Rerium indicum Mill. Shringivisha Acontium chasmanthum Stapfex Holm. Vishmushti Strychnox nuxvolnica Linn. Br. Vatsanabha Acontium chasmanthum Stapfex Holm. Drugs of vegetable origin Ahipena Papaver somniferurn Linn. Ex. Parasilka Yavani Hyocyamus inibar Linn. Drugs of Mineral Origin Gauripashna Arsenic Hartala Arseno sulphide Manahashila Arseno sulphide Parada Mercury Rasa Karpura Hydragyri subchloridum Tuttha Copper sulphate Hingula Cinnabar Sindura Red oxide of lead Girisindura Red oxide of mercury. Anai Kunri Adananthera povanina Linn. II. Arka Colotropis gigantean (linn. f. Alari Nerium indicum Mill. Gunj Abrus Jaipala (Jayapala) Croton tiglium Linn. . Danti Baliospermum montanum Mall. Arg. B. Rattha Polam Aloe barbadenisis Mill. Snuhi Euphorbia neriifolia Linn. III. AYRVEDIC SYSTEM I. Azhavanam Lawsonia inermis Linn. Dhattura Datura metal Linn. Bhallataka Semecarpus anacardium Linn. Bhanga Cannabis eativa Linn. Attru Thumatti Citrullus colocynthis Scharad. Drugs of Animal Origin Sarpa Visha Snake poison. Langali Gloriosa superba Linn.) R. SIDDHA SYSTEM Abini Papaver somniferum Linn.

Drugs of Vegetable Origin Afiyun Papaver somniferum Linn. II. Kuchla Strychnos nuxvomica Linn. Kattu thumatti Cucumis trigonus Roxb. Chadurakkalli Euphorbia antiquorium Linn. back and red) Tootiya Copper Sulphate Para Hydrargyrum Hartal Arsenic trisulphide (yellow).] . Thillai Enoecaria agallocha Linn. Aswad) and Ahmar) Arsenic (white. SIDDHA AND UNANI MEDICINES 73 IIaikalli Euphorbia neriifolia Linn. LEGAL STATUS OF AYURVEDIC. C. Asfar. Nervalam Croton tiglium Linn Pugai Elai Nicotiana tobacum Linn. Nabi Aconitum feron Wall. Ganja Cannobis sativa Linn. Shokran Conium maculatum Linn. Marukkarai Randia dumertorum Linn. Cheran Kottai Semicarpits anacardium Linn. Drugs of Animal Origin Sanp (head) Snake (head) Telni makkhi Mylabaris cichorii Linn. UNANI SYSTEM I. Kalappaik Kizhangu Gloriosa superba Linn. Etti Strychnos nuxvomica Linn. Mylaboris Pustulata Thumb Mylabaris rnacilenta III. Bish Aconitum chasmanthum Stapfex Holmes. Eezhaththalari Plumeria acuminate Ait. Kattamanakku Jatropha glandulifera Roxb. Keria polarn Atloe sp. Drugs of Mineral Origin Darachikna Hydrargyri perchloridum Hira Diamond Ras Kapoor Hydrargyri perchloridum Shingruf Hydrargyri bisulphuratum Zangar Cupri subaccetas Sammul-Far (Abyaz. Charas Cannabis sativa Linn. Dhatura seeds Datura metal Linn. Mansevikkalli Euphoriba sp. Bhang Cannabis sativa Linn. yellow. Gomatthai Datura stramonium Linn. Kunri Arbus precatorusi Linn. Kodikkalli Euphorbia tituqalli Linn. Bazrul-banj Hyoscyamus niger Linn.

cellophane. concentration prescribed on being satisfied that its use affords equal WARNING guarantee for preventing the growth (i) If irritation persists or increases.01 (e) In addition to complying with the per cent (This should not be provisions of the labeling laid down used in solutions of nitrates or in the rules the following particulars salicylates). discontinues the use and consult (c) be free from foreign matter. cent. of microorganisms. suspensions which are not The droppers to be supplied specifically required to comply with with the containers of ophthalmic the test for ‘Sterility’ in the solutions and suspension shall be Pharmacopoeia. (i) Benzalkonium Chloride. shall also be shown on the label of (ii) Phenyl mercuric nitrate: 0. surger y shall not have any (iii)The words ‘NOT FOR preservatives and be packed in single INJECTION’.001 container: per cent. (ii) Name and concentration of the Provided that solutions used in preservatives. packings. within one month after opening (iv) Phenyl ethyl alcohol: 0. Provided further that the Of containers or Carton or Package leaf-let: licensing authority may in his (i) Special instructions regarding discretion authorize the use of any storage. or other suitable organisms. except in case of those in any way be incompatible with the ophthalmic solutions and solutions. (i) The statement ‘Use the solution (iii)Chlorbutanol: 0.5 per the container’. or in suitable the unopened container of the plastic containers which would not manufacture. .5 per cent. (d) be contained in bottles made of (ii) Do not touch the dropper tip or either neutral glass or soda glass other dispensing tip to any surface specially treated to reduce the since this may contaminate solutions. physician. wherever applicable. 0. if used. preser vatives or var y the (ii) A cautionary legend reading as. dose container. SCHEDULE FF (See Rule 126-A) SCHEDULE FF Standards for Ophthalmic Preparations PART-A Ophthalmic Solutions & Suspension Ophthalmic Solutions and Suspensions shall – amount of alkali released when in (a) be sterile when dispensed or sold in contact of aqueous. made of neutral glass or of suitable (b) Contain one or more of the plastic material and when supplied following suitable substances to separately shall be packed in sterile prevent the growth of micro.

Siddha and Unani Medicines All Eye Ointment and other ophthalmic Schedule FF of Drugs and Cosmetics preparation should confirm to the Rule. SIDDHA AND UNANI MEDICINES 75 PART–B Ophthalmic Ointments Ophthalmic ointment shall – carton or package leaflet – (a) be sterile when dispensed or when (i) Special instructions regarding sold in the unopened container of storage wherever applicable. Ophthalmic Preparations in Ayurveda. (ii) A cautionary legend reading. (c) in addition to complying with the WARNING provisions for labeling laid down in If irritation persists or increases the rules the following particulars discontinue the use and consult shall be shown on the container or physician. (b) be free from foreign matter. . LEGAL STATUS OF AYURVEDIC. the manufacture.

Siddha and Unani standards. 1. dust or smoke. packaging and labeling will drugs in the market are exempted be in conformity with the provisions of from the purview of G. It shall be located so as to be: Good Manufacturing Practices i) Compatible with other Factory Premises: manufacturing operations that may The manufacturing plant should be carried out in the same or have adequate space for:– adjacent premises.– The building used following the prescribed process of for factory shall be such as to permit manufacturer of drugs which should production of drugs under hygienic be documented as a manual and kept conditions and should be free from for reference and inspection.M. It should However teaching institutions and have adequate provision of light and registered qualified Vaidyas.1(A) Location and surroundings. medicines shall be so situated and shall iii) Adequate quality control measures have such constructions as to avoid are adopted. The medicines on their own to dispense premises used for manufacturing. the Factory Act. cobwebs and insects/rodents. iv) The manufactured drug which is drain. i) Receiving and storing raw material ii) Adequately provided with working ii) Manufacturing process areas space to allow orderly and logical iii) Quality control section placement of equipment and iv) Finished goods store materials to avoid the risk of mix up . obnoxious odour or fumes or excessive v) To achieve the objective listed above. Siddha ventilation. 1. Siddha and Unani Medicines The Good Manufacturing Practices v) Office are prescribed to ensure that: vi) Rejected goods/drugs store i) Raw materials used in the manufacture of drugs are authentic. public lavatory or any factory released for sale is of acceptable which produces disagreeable or quality. each licensee shall evolve methodology and procedures for 1.1(B) Buildings. soot.P. to their patients and not selling such processing.SCHEDULE-T Good Manufacturing Practices for Ayurvedic.– ii) The manufacturing process is as has The factory building: for manufacture been prescribed to maintain the of Ayur vedic. The floor and the walls and Hakeems who prepare should not be damp or moist. contamination from open sewerage.2 General Requirements: of prescribed quality and are free from contamination.

1(F) Stores. in the processing area. vials manufacturing or control step. Interior surface washing. there shall be iii) Designed. might be prejudicial to the workers or 2) Raw material of mineral origin. If certain raw and proper exits should be there. etc. It should provide operations are carried out shall be independent adequate space for storage impervious to and be capable of of different types of material. The walls of the room proper ventilation and shall be free from in which the manufacturing dampness. materials procured for manufacturing iv) Provide with proper drainage system will be stored in the raw materials store. 6) Excipients etc. but sufficient care should raw material as well as prevent it from be taken to prevent f lies and damage due to dampness. public health shall be disposed off after 3) Raw material of animal source. the raw 1. such as not to permit retention or accumulation of dust or waste 1. Siddha and Unani system shall v) Furnace Bhatti section could be decide the use of appropriate containers covered with tin roof and proper which would protect the quality of the ventilation. dust.– All raw products. such as being kept clean. materials require such controlled environmental conditions. them harmless. microbiological contamination or rodent vi) There should be fire safety measures and insect infestation. smooth and free from cracks and permit easy cleaning and 1.– From the different categories of raw materials:– manufacturing sections and laboratories the waste water and the residues which 1) Raw material of metallic origin. The flooring shall raw material.– In components thereof and avoid the factories where operations involving the risk of omission of any use of containers such as bottles. suitable treatment as per guidelines of 4) Fresh Herbs.1(F)(A) Raw Materials.1(E) Container’s Cleaning. care may be taken to handle the following 1. SIDDHA AND UNANI MEDICINES 77 between different drugs or 1.– The water used materials stores may be sub-divide with in manufacture shall be pure and of proper enclosures to provide such potable quality. . constructed and adequate arrangements separated from maintained to prevent entry of the manufacturing operations for insects and rodents. cleaning and drying of such (walls. pollution control authorities to render 5) Dry Herbs or plant parts. The sanitary The manufacture based on the fitting and electrical fixtures in the experience and the characteristics of the manufacturing area shall be proper par ticular raw material used in and safe. floors and ceilings) shall be containers.– Storage should have disinfection. Adequate provision of conditions by suitable cabinization. or areas in the raw materials store. water for washing the premises shall be While designing such containers.1(C) Water Supply. LEGAL STATUS OF AYURVEDIC. packaging material and be smooth and even and shall be finished products. cabins made.1(D) Disposal of Waste. and jars are conducted. Ayurveda.

1(H) Health Clothing. “Approved Finished Goods Stock” area. raw material. for raw materials wherever necessary.– All works material shall be maintained. and stores within an area marked such lavatories shall be located at places “Quarantine” After the quality control separated from the processing rooms. employed in the Factory shall be free from contagious diseases.1(G) Working space. jars. and the climate and shall be clean. labels shall further indicate the identity of the particular supply in the form of 1. uniform suitable to the nature of work capsules etc.– All of the workers shall consist of proper packaging materials such as bottles. Records of the receipt.1(F)(B) Packaging Materials.– as clean towels. adequate space (manufacture and quality All the raw materials shall be control) for orderly placement of sampled and got tested either by the in. Separate production area after proper packaging provision shall be made for lavatories shall be stored in the finished goods to be used by men and women. source of supply and will If any Ayurvedic. laboratory and the experts have checked Workers will also be provided facilities the correctness of finished goods with for changing their clothes and to keep reference to its packing/labeling as well their personal belongings. equipment and material used in any of house Ayurvedic. and the date of manufacturing area shall provide receipt of the consignment. The clothing 1. prescribed. feet and packing the products. raw materials and to rejected raw material should be removed prevent the possibility of cross from other raw material store and should contamination of one drug by another be kept in a separate room. as the finished product quality as . Distribution records shall the label which indicates name of the be maintained as required. Siddha and Unani also clearly state the status of raw drug needs special storage conditions. No. then it will be moved to 8) Plant extracts and exudates/resins. head wherever required. SIDDHA AND UNANI MEDICINES 7) Volatile oils/perfumes & flavors. soap and scrubbing The finished goods transferred from the brushes shall be provided. Siddha and Unani the operations for which these are experts (Quality control technical employed so as to facilitate easy and person) or by the laboratories approved safe working and to minimize or to by the Government and shall be used eliminate any risk of mix-up between only on approval after verifying.1(F)(C) Finished Goods Stores. The different drugs. Procedure drug that is manufactured.– The Batch No. Only approved finished goods shall be Each container used for raw material dispatched as per marketing storage shall be properly identified with requirements. testing and 1. The All containers and closure shall be uniform shall also include cloth or adequately cleaned and dried before synthetic covering for hands. stored or of ‘First in first out’ should be adopted handled in the same premises. or Lot. Adequate facilities for personal cleanliness such 1.78 LEGAL STATUS OF AYURVEDIC. shall be stored properly. Sanitation approval or rejection and use of raw and Hygiene of Workers. material such as ‘UNDER TEST’ or finished goods store shall provide ‘APPROVED’ or ‘REJECTED’ The necessary environments requirements.

Siddha and Unani maintain a register to record all reports drugs manufactured irrespective of the of market complaints received regarding type of product manufactured (classical the products sold in the market.– The like taste. mashing. SIDDHA AND UNANI MEDICINES 79 1. drying.1(K) Batch Manufacturing Records. filtering. 1940 (23 of 1940). boiling. physical characteristics manufacturer shall also provide:– and chemical tests as may be necessary c) adequate facilities for first aid.– The licencee shall maintain 1.– For carrying out signed by Production and Quality manufacturing depending on the size Control Personnel respectively. with particular tests may include any in-house or attention being devoted to freedom pharmacopoeial test adopted by the from infections. tests conducted corrective action initiated to prevent during the various stages of manufacture recurrence of such market complaints .) Manufacturing records are on such market complaints investigations required to provide an account of the carried out by the manufacturers list of raw material and their quantities regarding the complaint as well as any obtained from the store. These may include shall be maintained. These records shall be duly 1. Details of operation and the nature of product or transfer of manufactured drug to the manufactured. labeling It should be essential to maintain and packing etc. Siddha and Unani mentioned the time of employment and in the First Schedule of the Drugs and periodical check up thereafter by a Cosmetics Act. machine movement of workers and orderliness and equipments used and to keep in in operations a suitably adequate space process record of various shodhana.1(M) Record of Market batch manufacturing record of each Complaints. have to be properly installed and maintained with proper cleaning. The preparation or patent and proprietary manufacturer shall enter all data received medicines. be cleared for sale. manpower. or indicated in the approved books of d) medical examination of workers at Ayurveda. Records thereof manufacturer in the raw material or in shall be maintained. To ensure ease in the record of date. These equipments grindings in terms of internal use. will be ensured between two machines Bhavana. the process material and in the finished product. roasting. grinding. and quantity of drugs transferred along automatically (Electrical or steam based) with record of testing of the finished or fully automatic machinery shall be product. 1. Only after the machines for use in the process of manufactured drugs have been verified manufacture such as crushing. filling. colour. records made available. and accepted quality shall be allowed to powdering. Siddha and Unani Drugs shall maintaining and performance of every be maintained in order to facilitate machine should be laid down.– Records Proper standard operational of sale and distribution of each batch of procedures (SOPs) for cleaning.– Manufactures shall batch of Ayurvedic. if any. if necessary.1(J) Equipments. suitable equipment either finished products store including dates manually operated or operated semi. LEGAL STATUS OF AYURVEDIC. burning in fire and specific or rows of machines. burning. and packaging.1(I) Medical Serv ices.1(L) Distribution Records. prompt and complete recall of the batch. Ayurvedic. These physician once a year. 1.

semi-finished products and The Register shall also be available for finished products are stored. that is literature or it is a new observation. for quality control section in his own 9.S. 4. Siddha Siddha and Unani systems of and Unani pharmacopoeial standard.U) as per expert. All raw materials will be monitored the manufacturers specification or other for fungal. 7. Quality control section will have a checks and control the quality of finished minimum of product being released to finished goods a) one person with Degree store/warehouse. material. shall be as per the Ayurvedic. in the product. Manufacturing records should be with the quality control section. 1970 (84 1. Pharmacognosy and samples should be maintained. The record of specific method and reactions are already reported in the procedure of preparation. maintained for the various process. Siddha and Unani manufacturer. “Bhavana”. For identification of raw drugs.1(N) Quality Control. SIDDHA AND UNANI MEDICINES shall also submit the record of such of conditions under which raw complaints to the licensing authority. The test pharmacopoeias of Ayur vedic.80 LEGAL STATUS OF AYURVEDIC.0 Requirement for Sterile Product: controlled samples of finished products of each batch will be kept A) Manufacturing Areas. The standards for identity. Unani 5. separate enclosed . the of India shall be complied with. and whether such 8. “Mardana” and “Puta” and the record of every process 1. purity premises or through Government and strength as given in respective approved testing laboratory. materials monitor in process. medicines published by Government Where the tests are not available. To supervise and monitor adequacy and Siddha drugs. There should be 150 sq feet area of 1970) of a recognized for quality control section. test should be performed according to 10. The quality with a view to minimize such control section shall verify all the raw contamination. and storage requirements for the Reports of any adverse reaction drugs. Chemistry may be associated 3. quality 11. The quality control section shall Schedule II of Indian Medicine have the following facilities: Central Council Act.– For the for 3 years. Manufactures who are Siddha and Unani drugs shall also be manufacturing patent proprietary maintained in a separate register by each Ayur veda. Preferably for such qualification in Ayur veda/ quality control there will be a separate Siddha/Unani (A. bacterial contamination information available. resulting from the use of Ayurvedic. manufacture of sterile Ayurvedic. inspection during any inspection of the 6.– Ever y carried out by the manufacturer shall licensee is required to provide facility be maintained. Keep record in establishing shelf life premises. university of Board. 2. The manufacturer shall medicines shall provide their own investigate any of the adverse reaction specification and control references to find if the same is due to any defect in respect of such formulated drugs. b) Provided that Bachelor of reference books and reference Pharmacy. To verify the finished products 3.

For sterile systems for sterile products. design of the areas shall preclude the All process controls as required possibility of the products intended for under master formula including room sterilization being mixed with or taken temperature. Result of such checked using intensity. relative humidity. In case filled. areas shall be designed to facilitate d) Designing laminar flow sterile air cleaning and disinfection. For all B) Precautions against areas where aseptic manufacture has to contamination and mix:– be carried out. count shall be checked against f) Individual containers of liquids and established in-house standards and ophthalmic solutions shall be record maintained. The filters operating in an isolated enclosure shall be checked for performance on within the building. and compare actual yield against Siddha and Unani drug that can be theoretical yield before final sterilized in their final containers. the manufacturing areas shall be written g) Expert technical staff approved by down and displayed. and shall be essentially dust free and ventilated with an air supply. SIDDHA AND UNANI MEDICINES 81 areas specifically designed for the design of the areas shall preclude the purpose shall be provided. These areas possibility of mix up between non-sterile shall be provided with air locks for entry and sterile products. the Licensing Authority shall check For the manufacture of Ayurvedic. the distribution of the batch. volume to be products already sterilized. LEGAL STATUS OF AYURVEDIC. . examined against black-white Access to manufacturing areas shall background fitted with diffused light be restricted to minimum number of after filling to ensure freedom from authorized personnel. installation and periodically thereafter b) Using appropriate pressure the record of checks shall be maintained. Special procedure contamination with foreign to be followed for entering and leaving suspended matter. the checked and recorded. Siddha and Unani drug lamps shall be checked and recorded manufacturing areas shall be carried indicating the burning hours or out during operations. leakage and clarity shall be of terminally sterilized products. All the surfaces in sterile manufacturing c) Providing a suitable exhaust system. air supply shall be filtered a) Carr ying out manufacturing through bacteria retaining filters (HEPA operations in a separate block of Filters) and shall be at a pressure higher adequately isolated building or than in the adjacent areas. differential in the process area. manufacturing routine microbial counts e) The germicidal efficiency of UV of all Ayurvedic.

. Equipment and Minimum Manufacturing Premises required for the Manufacture of Various Categories of Ayurvedic. End runner/Ball – Mill Sieves/Shifter 2. Churan/Nasya/ 200 sq. Partitions for each activity.82 LEGAL STATUS OF AYURVEDIC. If Unani medi- cines are manufactured in same premises and additional area of 400 sq. SIDDHA AND UNANI MEDICINES PART-II A. Siddha System of Medicines Sl. List of Machinery. polishing pan in case of sugar coated tablets. mechanised chattoo (for mixing of guggul) where required. Medicine Space required recommended 1200 square feet covered area with separate cabins. feet will be required. Anjana/Pisti 100 sq. feet Karel/mechanized/ motorized. stainless steel trays/containers for storage and sugar coating. feet Ball Mill. Tablet compressing machine pill/vati cutting machine. feet Grinder/Disintegrator/ Manjan Lepa/ Pulverizer/Powder Kwath Churn Mixer/sieves/shifter 3. Category of Minimum manufacturing Machinery/equipment No. kharel. Pills/Vatti/Gutika 100 sq. Mass Mixer Powder mixer Granulator drier. 1.

feet Same as mentioned above. feet Ear then lamps for collection of Kajal. P. Filter Press. 10.S Patila. feet Bhatti section fitted with Modak/Lakayam Exhaust Fan and should be fly proof.S Patila. Muffle furnace (Electrically operated) End/Edge Runner. 5. exhaust Kwath Manapaku fan fitted and fly proof Bhatti section. 6. End Runner/Mill (Where required) S.S. Gaj Put Bhatti.S Storage Container. Wooden/S. Thermometer. hygrometer. Kajal 100 sq.P. Spatula. 7. feet Bhatti. Capping Machine. 8. Panak Syrup/Pravahi 150 sq. Pak/Avaleh/Khand/ 100 sq. SIDDHA AND UNANI MEDICINES 83 Sl. Kupi pakva/Ksara/ 150 sq. Iron Kadahi/S. End Runner. feet Tinctum press. Karahi/Stainless Parpati/Lavana Bhasma steel Vessels/Patila Flask. Copper Rod. Sieves. Category of Minimum manufacturing Machinery/equipment No. Ointment/Marham 100 sq. Filling/packing and manufacturing room should be provided with exhaust fan and ultra violet lamps. Capsules 100 sq. filter press Gravity filter Liquid filling machine. LEGAL STATUS OF AYURVEDIC. Asava/Aristha 200 sq. 9. . feet Air Conditioner de- humidifier. Tipple Roller Mill. Exhaust Fan.S Patila and S. Medicine Space required recommended 4. Bottle washing machine. Earthen container. S. feet Tube filling machine Passi Crimping Medicine/ Ointment Mixer. Satva/Sindura Kapur/ Multani/Matti/Plaster Uppu Param of Paris. Capsule filling machine and chemical balance.S Storage Container S. Fermentation tanks containers and Distillation plant where necessary.

removal of smoke. 14. insects. Storage Containers. mixing and storage tanks or stainless steel or of other suitable material sintered glass funnel. 16. Patila S. Filtration Equipment filling tank with tap/Liquid filling machine. Distillation plant. dust etc. puta.84 LEGAL STATUS OF AYURVEDIC. Aschyotan/Netra 100 sq. Liquid filling tank with tap/Gravity filter/Filter press. Kadahi/S. autoclave. 15. feet unit will have a separate area for Bhatti. Visual inspection box. prevention of files. SIDDHA AND UNANI MEDICINES Sl. Category of Minimum manufacturing Machinery/equipment No.S. Sura 100 sq. static control. Tail Ghrit Nev 100 sq. . feet Hot air oven electrically Malham Panir heated with thermo- Karn bindu. 13. seitz filter or filter candle. feet Same as mentioned above plus Distillation plant and Transfer pump. feet Bhatti. etc. tube filling equipment. boilers. feet Maceration tank. Ark Tinir 100 sq. liquid filling equipment. Each manufacturing 200 sq.S. The furnace section could have tin roof. This will have proper ventilation. furnaces. cattle gas Nasa bindu or electically heated with suitable mixing arrangement collation mill or ointment mill. Medicine Space required recommended 12.

Bottle Filling machine. Medicines are also Manufactured in same premises an additional area of 400 square feet will be required. majoon/Laooq/ Sieves. Sl. packing of liquids could also be shared for these items. Arq. S. List of Machinery. feet Distillation Plant (garembic) S. 2. Similarly some of the manufacturing area like powdering. 100 sq. Bhatti and other accessories. furnace. Equipment and Minimum Manufacturing Premises Required for the Manufacture of Various Categories of Unani System of Medicines One medicine indicated for one category of medicine could be used for the manufacturing of other category of medicine also. Bottle drier. SIDDHA AND UNANI MEDICINES 85 B. Mass Mixer Tablets Powder mixer Granulator drier. LEGAL STATUS OF AYURVEDIC. Planter mixer for Khamiras. Bottle washing machine. Gravity filter. Itrifal Tiryao 100 sq.S Storage Tank. partitions for each acti- vity. Habb (Pills) and 200 sq. Medicine Space required recommended 1200 square feet covered area with separate cabins. Category of Minimum manufacturing Machinery/equipment No. feet Ball Mill. If Ayurveda/Siddha. feet Grinder/Pulveriser.S Patilas. 3. Boiling Vessel. 1. Tablet compressing machine pill/vati cutting . powder mixer Jawarish Khamiras (if required).

S. Apparatus. Scoops. Zimad 100 sq. 5. Marham. Surma. S. Qurs (Tab) 100 sq. Trays. Vessel 7. Sil Batta. 4. polishing pan in case of sugar coated tablets. Medicine Space required recommended machine. Drier Tablet Compressing Machine. Powder mixer (Where required). feet Grinder/Pulveriser. feet End runner. Scoops. Shiyaf. SIDDHA AND UNANI MEDICINES Sl. End (Ointment) runner. Tripple Roller Mill (if needed) 8. Granulator. stainless steel trays/containers for storage and sugar coating. Gendna. O. Sufoof (Powder) 100 sq. feet Oil Expeller. feet Bhatti. 9. Raughan (oils) 100 sq. Kajal 100 sq. 6. Patilas (Crushing & boiling) oil Filter bottle.T.S. Sieves. Bhatti . feet Kharal. Pulveriser. Bhatti. polishing pan Heater. Balance with weights. Powder mixer (where needed). Die punches Trays. Filling machine. Earthen pots 10. Kushta 100 sq.86 LEGAL STATUS OF AYURVEDIC. Kharal. feet Grinder/Pulveriser. Sieves. Category of Minimum manufacturing Machinery/equipment No. Capacity. Bhatti. Bottle drier. feet Aluminium Vessels 50- 100 kgs. Sugar Coating Pan. Murabba 100 sq. mechanised chattoo (for mixing of guggul) where required. Grinder. mixing S.

dust etc. capsule filling machine. LEGAL STATUS OF AYURVEDIC. 13. Air Conditioner. glass. boilers. eye ointment) 14. Qutoor Chasm and 100 sq. Gravity filter. SIDDHA AND UNANI MEDICINES 87 Sl. Kettle. putta. Sharbat & Jushanda 100 sq. Liquid filling tank with tap/liquid filling machine. Bottle washing machine. Capsule 100 sq. Filter Press. Category of Minimum manufacturing Machinery/equipment No. furnaces. feet Pulveriser. . exhaust fan fitted. insects. Hot air oven eclectically heated with thermostatic control. Hot air oven electrically heated with thermostatic control. etc. De humidi- fier Balance with weights. Each manufacturing 200 sq. Medicine Space required recommended 11. feet unit will have a separate area for Bhatti. storage containers. removal or smoke. This will have proper ventilation. Bhatti section. feet Marham (Eye drops. 12. cettle. prevention of files. feet Tinctum Press. Powder mixer (where needed).

Tablet Disintegration Apparatus 8. Moisture Meter 10. List of Equipment Recommended for In-House Quality Control Section (Alternatively unit can get the testing done from the government approved laboratory) (A) Chemistry section (B) Pharmacognosy section 1. pH Meter 25. De-humidifier 24. Glass/Steel Distillation Apparatus 16. Chemicals. Boiling Point Determination Apparatus 3. Centrifuge machine 23. Water Bath (Temperature Controlled) 18. Limit Test Apparatus Note: The above requirement of machinery. Refrigerator 15. if he is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter then in the circumstances in a particular case. 9.Camera Lucida (Prism and Mirror Type) 8. Paper Chromatography apparatus with accessories 21. Microscope Binocular (complete set) 2. Melting Point Determination Apparatus 4. Polarimeter 6. qualifications are made subject to the modification at the discretion of the Licensing Authority.Dissecting Microscope 3. Heating Mantles/Hot Plates 19. Muffle Furnace 11. Hot Air Oven 14. TLC apparatus with all Accessories (Manual) 20. Glass-ware etc. equipments. . Volatile Oil Determination Apparatus 2.Aluminium Slide trays 6. Electronic Balance 12. Viscometer 7.Stage Micrometer 7. SIDDHA AND UNANI MEDICINES C. Alcohol Determination Apparatus 1. LPG Gas Cylinders with Burners 17.Microtome 4. Magnetic Stirrer 13.Physical balance 5. Refractometer 5. Sieve Size 10 to 120 with Sieve shaker 22. space.88 LEGAL STATUS OF AYURVEDIC.

1940 Government of on the label because of their large India in the Ministry of Health & Family number the same shall be indicated in Welfare. K-11020/5/97-DCC (AYUSH) Government of India Ministry of Health & Family Welfare (Department of Ayurveda. Yoga the leaflet to be inserted in the package. Red Cross Road.No. Order issued by Govt. 1945. ‘Caution to be taken under medical Unani and Siddha (ASU) drugs to ensure supervision’ if the list of ingredients full compliance by all ASU drug contains a substance specified in manufacturers of the provisions of Rule Schedule E (1) of the Drugs & 161 (1) and (2) relating to displaying Cosmetics Rules 1945. Siddha and Further that the container of a medicine Homoeopathy (AYUSH) directs the shall conspicuously display the words state Licensing Authorities of Ayurveda. Unani. and Unani drug. Department of Ayurveda. Yoga & Naturopathy. New Delhi-110001 Dated: October 10. 1. Unani. Siddha. 2005 ORDER In exercise of the powers conferred ingredients incorporated therein. with the quantity of each of the Sd/- Shiv Basant Joint Secretary to Govt. The State ASU on the label of the container or package Drug Licensing Authorities shall of an Ayurveda. & Naturopathy. In case under Section 33P of the Drugs & all the ingredients can not be mentioned Cosmetics Act. of India . forthwith cancel or suspend the licenses the true list of all the ingredients (official of the defaulting ASU Drug and botanical names) used in the Manufactures under Rule 159 of the manufacture of the preparation together Drugs & Cosmetics Rules. Siddha and Homoeopathy) (AYUSH) Red Cross Building. of India. ORDERS Deptt. of Ayush F.

1945. Unani. in pursuance of the Government of India in the Ministry Section 33P of the Drugs and Cosmetics of Health & Family Welfare. Yoga & of India in the Ministry of Health and Naturopathy. New Delhi-110001 Dated: October 13. Yoga & Naturopathy. Unani and Siddha (ASU) manufactures for revocation of their drugs under Rule 157 of the Drugs & licenses under Rules 157. 1945 thereto are not being followed by a very for failure to comply with the Good large number of Ayurveda. Sd/- Shiv Basant Joint Secretary to Govt. K-11020/5/97-DCC (AYUSH) Government of India Ministry of Health & Family Welfare (Department of Ayurveda. Homoeopathy (AYUSH) that the Good hereby directs that all the State ASU Manufacturing Practices (GMP) as Drug Licensing Authorities take action prescribed for the preparation of against the defaulting ASU drug Ayurveda. Department of AYUSH. financial assistance being provided to the ASU drug manufactures to become GMP compliant.90 LEGAL STATUS OF AYURVEDIC. SIDDHA AND UNANI MEDICINES F. 1. Siddha and Homoeopathy) (AYUSH) Red Cross Building. 1940 (23 of 1940). 2005 ORDER Whereas it has come to the notice of Now. Siddha and Family Welfare. therefore.No. 158 and 159 Cosmetics Rules 1945 and Schedule T of the Drugs & Cosmetics Rules. Act. of India . Red Cross Road. Unani. the Government Department of Ayurveda. Siddha and Manufacturing Practices notified under Unani Drug Manufacturers in spite of Schedule ‘T’ of the Drugs and Cosmetics sufficient time being allowed and Rules.

Government of India in before self-certification. 2005 ORDER Whereas it has come to the notice of Homoeopathy (AYUSH) hereby makes the Government of India in the Ministry testing for heavy metals namely. of India . of Health & Family Welfare. This process of the Ministry of Health & Family Welfare. self-certification would be extended for Department of Ayurveda.No. if proper batch-wise testing is not done (23 of 1940). get their drugs tested by any approved Unani and Siddha drug manufactured drug testing laboratory. Siddha and Sd/- Shiv Basant Joint Secretary to Govt. SIDDHA AND UNANI MEDICINES 91 F. in pursuance of the export purposes and the ASU drug powers conferred under Section 33 EEB manufacturer will be held responsible of the Drugs and Cosmetics Act. unsatisfactor y Agricultural and the permissible limit will be one ppm. Unani. cultivation practices relating to the Conspicuous display on the medicinal plants used in preparation of container of purely herbal Ayurveda. Siddha and Homoeopathy) (AYUSH) Red Cross Building. Therefore. Yoga & recommended by WHO publication Naturopathy. Ayurveda. Yoga & sale within the country in due course. Naturopathy. Mercury and Cadmium will be as Department of Ayurveda. by all licensees. Unani. This is a process of self-certification for Now. Yoga & Naturopathy. in the interest of public health to ASU Drug manufactures who do not introduce mandatory testing for heavy have in-house laboratory facility shall metals for every batch of Ayurveda. 1940. therefore. out. 1. Red Cross Road. it has become expedient 2006. LEGAL STATUS OF AYURVEDIC. Unani. New Delhi-110001 Dated: October 14. K-11020/5/97-DCC (AYUSH) Government of India Ministry of Health & Family Welfare (Department of Ayurveda. Lead. Arsenic. Siddha and “Quality Control Methods For Medicinal Homoeopathy (AYUSH) that due to Plants Materials” In case of Mercury. the the words HEAVY METALS WITHIN presence of heavy metals above the PERMISSIBLE LIMTS” will be permissible limit therein cannot be ruled mandatory with effect from 1st January. Siddha & Unani (ASU) and Siddha and Unani drugs to be exported general environmental pollution.

in. 2005 ORDER Central Government vide its Order of be an essential part of the consignment even number dated 14. Health and Family Welfare.e.2005 has papers to be submitted by any exported made testing for heavy metals.2005 as modified hereby hereby partially modified as follows: shall come into force from 1st January. Siddha and Homoeopathy) (AYUSH) Red Cross Building. of India www. Siddha and Unani medicines medicines finds it difficult to display on are hereby directed to either container of purley herbal Ayurveda. Siddha and Unani Government vide the order of even medicines comply with this Order w. Representations have medicines shall be responsible for the been received from Ayurveda Drugs genuineness of the test report of the Manufacturers Association (ADMA) that approved laboratory submitted along the exporters may find it difficult to with other consignment papers at the print the certificate “Heavy metals Airport/Port of Shipment. Red Cross Road. Government 2006. Ministry of of the importing countries by 1st January. The regulatory authorities of the importing list of approved laboratories and the countries and it may not be possible to permissible limits of heavy metals have get revised containers and labels been posted on the website of the approved by the regulatory authorities Department of AYUSH. The test 1st January 2006. 2006 which will be Arsenic. Siddha and Unani medicines herbal Ayurveda. New Delhi-110001 Dated: October 14. K-11020/5/97-DCC (AYUSH) Government of India Ministry of Health & Family Welfare (Department of Ayurveda.10. Unani.No.f number dated 14. Siddha and Unani Ayurveda.10. of India . report of an approved laboratory will Sd/- Shiv Basant Joint Secretary to Govt. All GLP/ within permissible limit” on the NABL accredited laboratories are container of the medicines as container approved by the Central Government and label are to be approved by the for the above mandatory testing. indianmedicine. All exporters of purely herbal herbal Ayurveda. Siddha and Unani by every licensee.92 LEGAL STATUS OF AYURVEDIC. Lead.nic. conspicuously display on the container Siddha and Unani medicines to be of purely herbal Ayurveda. Yoga & Naturopathy. the above mentioned order the Drugs and Cosmetics Act. respect of every batch of purely herbal The manufacturers/exporters of purely Ayurveda. the manufacturer limit” or furnish the above mentioned shall submit batch wise testing reports certificate from an approved laboratory in respect of every purely herbal along with other consignment papers. Siddha and exported the words “Heavy metals Unani medicines to be exported the within regulatory requirements of the words “Heavy metals within permissible importing country.2005 is dated 14. Ayurveda. Mercury and Cadmium examined by the representative of the mandatory for export purposes in DCG (I) at the Airport/port of shipment.10. Siddha and Unani medicine It will be the responsibility of the to be expor ted from approved representative of DCG (I) deployed at laboratories certifying that the medicine the Airport/port of shipment to examine contains heavy metals within permissible and ensure that all exporters of purely limits as laid down by the Central herbal Ayurveda. In case any manufacturer of purely 2006. namely. from 1st January. 1940 of even number dated 14. 1.10.2005. SIDDHA AND UNANI MEDICINES F. In view of the above difficulties The order issued by the Central brought to the notice of the Central Government under Section 33 EEB of Govermnet.

or . (iii)any article. other than food. and applies also to persons domiciled c) ‘magic remedy’ includes a talisman. unless the function of the body of human context otherwise requires. to possess miraculous powers for or (3) It shall come into force on such in the diagnosis. cure. referred to except the State of Jammu and Kashmir. in the territories to which this Act mantra. or for affecting or influencing in any way the structure or any organic 2. (Objectionable Advertisements) Act. (ii) and (iii). and any announcement (i) who holds a qualification made orally or by any means of granted by an authority specified producing or transmitting light. cure. component of any medicine.– (1) This Act may organic function of the body of be called the Drugs and Magic Remedies human beings or animals. (2) It extends to the whole of India substance or article. disease in human beings or animals appoint.– beings or animals. and any other extends who are outside the said charm of any kind which is alleged territories. or animals. Short Title. date as the Central Government may. treatment or remedies alleged to possess magic prevention of disease in human qualities and to provide for matters beings or animals. label. in. 1916 (7 of 1916) or (i) a medicine for the internal or specified in the Schedules to the external use of human beings Indian Medical Council Act. connected therewith. of the Indian Medical Degrees b) ‘drug’ includes. Act. in sub-clauses (i).– document. Definitions. treatment or prevention of any by notification in the Official Gazette. a) ‘advertisement’ includes any notice. to prohibit the used for or in the diagnosis. [(cc) ‘registered medical practitioner’ circular. Extent And in any way the structure or any Commencement. intended to affect or influence 1. 1954 (21 OF 1954) [30th April. or notified under. kavacha. advertisement for certain purposes of mitigation. wrapper.– In this Act. or other means any person. mitigation. The Drugs and Magic Remedies (Objectionable Advertisements) Act. section 3 sound or smoke. (iv) any article intended for use as a 1954. 1956 (102 of 1956). 1954] An Act to control the advertisement (ii) any substance intended to be of drugs in certain cases.

or use of that drug for – c) is otherwise false or misleading in a) the procurement of miscarriage in any material particular. persons having special knowledge (ii) the publication of any or practical experience in respect of advertisement outside the Ayurvedic or Unani systems of territories to which this Act medicines as that Government extends by or at the instance of deems fit. disorder or condition specified in section 3. disorder or condition directly or indirectly claims to be specified in the Schedule. or export from. and. Prohibition of Advertisement of person shall take any part in the Certain Drugs for Treatment of publication of any advertisement relating Certain Diseases and Disorders.– No person shall made except. India of Certain Provided that no such rule shall be Advertisements. 1940 (23 of 1940) of any advertisement’ includes.– Subject to the provisions of this Act.94 LEGAL STATUS OF AYURVEDIC. women or prevention of conception in women. or person carrying on or purporting to c) the correction of menstrual disorder carry on the profession of administering in women. or suggest or are calculated to lead to the b) makes a false claim for the drug. if the Central Government (i) the printing of the considers necessary. disorder territories to which this Act extends any or condition which requires timely document containing an advertisement . (by whatsoever name called) which may be specified in the rules made 6.] constituted under the Drugs and d) ‘taking any part in the publication Cosmetics Act. the (i) in respect of any disease. Prohibition of Advertisement of b) the maintenance or improvement of Magic Remedies for Treatment of the capacity of human beings for Certain Diseases and Disorders. or magic remedies shall take any part in d) the diagnosis. and under this Act: Export from. or 5. the publication of any advertisement treatment or prevention of any referring to any magic remedy which disease. Prohibition of Misleading territories.– to a drug if the advertisement contains Subject to the provisions of this Act. Prohibition of Import into.– No sexual pleasure. SIDDHA AND UNANI MEDICINES (ii) who is entitled to be registered treatment in consultation with a as a medical practitioner under registered medical practitioner or for any law for the time being in which there are normally no force in any State to which this accepted remedies.] a person residing within the said 4. mitigation. no 3.– import into. Advertisements Relating to Drugs. or any efficacious for any of the purposes other disease. with such other advertisement. and Act extends relating to the (ii) after consultation with the Drugs registration of medical Technical Advisor y Board practitioners. cure. no any matter which- person shall take any part in the a) directly or indirectly gives a false publication of any adver tisement impression regarding the true referring to any drug in terms which character of the drug.

if any. from such document. Penalty. Powers of Entry. inform a Magistrate and take 8. apply to any imprisonment which may extend to search or seizure under this Act as they six months. every for which he is so authorized. shall have effect accordingly. was in charge of. with shall. article or thing which knowledge or that he exercised all due contains any such advertisement. on (2) The provisions of the Code of conviction. if any. utility or saleable value of the Sea Customs Act. under the authority of a warrant issued b) in the case of a subsequent under section 98 of the said Code. diligence to prevent the commission of including the contents. with imprisonment (3) Where any person seizes which may extend to one year. and was times. 1898 (5 of 1898) a) in the case of a first conviction. conviction. or anything under clause (b) or clause (c) with fine. at the time the offence was a) enter and search at all reasonable committed. Offences By Companies. as responsible to. within the local limits of the area provisions of this Act is a company. register. or with apply to any search or seizure made both. Search. or with both. 1878 (8 of thereof. or with fine. rules made there under] shall.– Whoever contravenes any of an offence punishable under this of the provisions of this Act [or the Act. 1878) and all the provisions of that Act c) examine any record. SIDDHA AND UNANI MEDICINES 95 of the nature referred to in section 3. .– (1) his orders as to the custody thereof. etc. of sub-section (1). he shall. and any advertisement cannot be separated documents containing any such by reason of its being embossed or advertisement shall be deemed to be otherwise. of such such offence. LEGAL STATUS OF AYURVEDIC. the company for the he considers necessary. be punishable – Criminal Procedure.– person who. except that document or any other material section 183 thereof shall have effect as object found in any place mentioned if for the word ‘shall’ therein the word in clause (a) and seize the same if ‘may’ were substituted. as soon as may be. goods of which the import or export article or thing without affecting the has been prohibited under section 19 integrity. or document.– (1) If authorised by the State Government the person contravening any of the may. any Gazetted Officer 9. any place in conduct of the business of the company which he has reason to believe that as well as the company shall be deemed an offence under this Act has been to be guilty of the contravention and or is being committed. so far as may be. article or thing. shall be liable to be proceeded against b) seize any advertisement which he and punished accordingly: has reason to believe contravenes Provided that nothing contained in any of the provisions of this Act: this sub-section shall render any such Provided that the power of person liable to any punishment seizure under this clause may be provided in this Act if he proves that exercised in respect of any the offence was committed without his document. with such assistants. if the section 4. or section 5. he has reason to believe that it may furnish evidence of the commission 7.] Subject to the provisions of any rules made in this behalf.

– Ever y person may. Explanation. Saving. manager. committed by a company and it is proved 12.– the Schedule or the rules made Notwithstanding anything contained in under this Act is undertaken in those the Code of Criminal Procedure. or the officer of the company. article or thing. such director. in printed or published by any person respect of which the contravention is with the previous sanction of the made. secretary this Act. force.– No or social standpoint. Forfeiture. an offence punishable b) any treatise or book dealing with under this Act shall be cognizable. or court inferior to that of a Presidency c) any advertisement relating to any Magistrate or a Magistrate of the first drug sent confidentially in the class shall try any offence punishable manner prescribed under section 16 under this Act. prosecution that the offence was committed with or other legal proceeding shall lie against the consent or connivance of. and on his premises indicating that b) ‘director’ in relation to a firm means treatment for any disease. Indemnity.– For the purposes of 14.– The officer of the company shall also be provisions of this Act are in addition to. secretary or other 13. Jurisdiction To Try Offences.– apply to – a) ‘company’ means any body a) any signboard or notice displayed corporate and includes a firm or by a registered medical practitioner other association of individuals. 1898 premises. or is any person for anything which is in good attributable to any neglect on the part faith done or intended to be done under of. only to a registered medical [10A. or been convicted by any cour t for d) any advertisement relating to a drug contravening any provision of this Act printed or published by the or any rule made thereunder. Officers to be Deemed to be Provided that the Government Public Servants. any director or manager.– Nothing in this Act shall this section. [9a.] Advertisements) Amendment Act.] any of the matters specified in section 3 from a bona fide scientific 10. deemed to be guilty of that offence and and not in derogation of the provisions shall be liable to be proceeded against of any other law for the time being in and punished accordingly.– Where a person has practitioner.– No suit. or (5 of 1898). or may direct that any document (including e) any advertisement relating to a drug all copies thereof). Other Laws Not Affected. Offences to be Cognizable. 1963 (42 of 1963): 11. or condition specified in section 3. disorder a partner in the firm. including the contents thereof Government granted prior to the where such contents are seized under commencement of the Drugs and clause (b) of sub-section (1) of section Magic Remedies (Objectionable 8.96 LEGAL STATUS OF AYURVEDIC. the court Government. for reasons to be recorded in authorized under section 8 shall be . SIDDHA AND UNANI MEDICINES (2) Notwithstanding anything deemed to be a public servant within contained in sub-section (1) where an the meaning of section 21 of the Indian offence under this Act has been Penal Code (45 of 1860). shall be forfeited to the Government.

4. both Houses agree in making relation to the advertisement of any such any modification in the rule or both drug or class of drugs [or any such class Houses agree that the rule should not of advertisements relating to drugs]. so notification in the Official Gazette. SIDDHA AND UNANI MEDICINES 97 writing.– (1) The effect only in such modified form or be Central Government may. Power to Exempt from advertisements of articles or things Application of Act. by of no effect. withdraw the sanction after foregoing power. as soon as may be after it [or any specified class of advertisements is made. disorder or showing cause against such condition] to which the provisions withdrawal.] of section 3 shall apply. 5 and 6 or any one of more successive sessions and if before such provisions shall not apply or shall the expiry of the session in which it is apply subject to such conditions as may so laid or the successive sessions be specified in the notification to or in aforesaid. such rules may- giving the person an opportunity of a) specify any [disease.] prejudice to the generality of the . that any such modification or rules for carrying out the purposes of annulment shall be without prejudice this Act. be made. make however. b) prescribe the manner in which 15. as the case may be. before each of House of relating to drugs] should be permitted. Parliament while it is in session for a it may.– If in the opinion referred to in clause (c) of section of the Central Government public 14 may be sent confidentially. direct that the provisions of comprised in one session or in two or sections 3. LEGAL STATUS OF AYURVEDIC. interest requires that the advertisement [(3) Every rule made under this Act of any specified drug or class of drugs shall be laid. Power to Make Rules. to the validity of anything previously (2) In particular and without done under that rule. by notification in the Official total period of thirty days which be Gazette. the rule shall thereafter have 16.

Glaucoma 53. Ruptures 17. Sexual impotence 18. including 26. kidney stones and 50. gonorrhoea. Tuberculosis bladder stones 51. Deafness 35. Form and structure of the female bust 49. Trachoma 22. Epilepsy 45. Rheumatism 16. Appendicitis 28. Blindness 30. Disorders of the nervous system 42. Diseases and Disorders of the 38. High/Low Blood Pressure chancre. Diseases and Disorders of the uterus 40. Disorders of menstrual flow 41. Infantile paralysis 4. Pneumonia 15. Diseases and Disorders of brain 37. Hysteria 3. Sterility in women 21. Female diseases (in general) 46. Arteriosclerosis 29. Goitre 54. Venereal diseases. Cancer 33.SCHEDULE Diseases and Ailments (by whatever Name described) which a Drug may not Purport to Prevent or Cure or Make Claims to Prevent or Cure 1. Bright’s disease 32. Fevers (in general) 47. Pleurisy 14. Cataract 34. Dropsy 44. soft 27. Stature of persons 20. Diabetes 36. Paralysis 12.] . Hydrocele 2. Gangrene 52. Gall stones. Disorders of the prostatic gland 43. Lockjaw 8. Tumours 23. Nervous debility 11. Lupus 10. Leucoderma 7. Heart diseases syphilis. venereal granuloma and lympho granuloma. Typhoid fever 24. Fits 48. Leprosy 6. Insanity 5. Plague 13. Obesity optical system 39. Locomotor ataxia 9. Ulcers of the gastro-intestinal tract 25. Smallpox 19. Blood poisoning 31.

namely:.– (1) If the Customs such further time as may be allowed in Collector has reasons to believe that any this behalf by the person so authorized consignment contains documents of the . within such from India of Certain time as may be specified in the order or Advertisements. the that drug as he deems necessary for Central Government hereby makes the holding the scrutiny of the advertisement following rules. name and address of the manufacturer. unless relating to a drug shall be deemed to the context otherwise requires. Short Title and packer. distributor or prohibiting Import into. 1955 In exercise of the powers conferred by information regarding the composition section 16 of the Drugs and Magic of the drug or the ingredients thereof Remedies (Objectionable Advertise. unless such Advertisements) Act. seller or advertising person authorized by the State agency. if caused such adver tisement to be satisfied. comply with such order shall.– [Any packer. packer. The Drugs and Magic Remedies (Objectionable Advertisements) Rules. and Export seller of the drug to furnish. the authorized person in this behalf calling upon him or it to furnish the [3] Scrutiny of Misleading Advertise.– In these rules. to a drug contravenes the provisions of section 4]. Definitions. be deemed to be (2) They shall come into force on a contravention of the provisions of such date as the Central Government section 4: may. by order. Any failure to (Objectionable Advertisements) Rules. advertising agency of any medium for the dissemination of any advertisement 2 . or any other information in regard to ments) Act. by notification in the Official Provided that no publisher or Gazette. distributor.– have made any contravention merely by (1) the “Act” means the Drugs and reason of the dissemination by him or Magic Remedies Objectionable if any such advertisement. distributor or seller of the drug Commencement. that an advertisement relating disseminated. purposes of section 7. ments Relating to Drugs. 1954 (21 of publisher or advertising agency has failed 1954). 1. appoint. require the [4] Procedure to be followed in manufacturer. and where any such order is made.– (1) These rules may to which the advertisement relates to be called the Drugs and Magic Remedies comply with the order. as the case may be. it shall be the duty of the manufacturer. 1954 (21 of 1954). who or which Government in this behalf may. and to comply with any discretion made by (2) “section” means a section of the Act. for the 1955.

100 LEGAL STATUS OF AYURVEDIC. Asthma 2. cure.– All also inform the importer or exporter of documents containing advertisements the order so passed: relating to drugs referred to in clause Provided that if the importer or (c) of sub-section (1) of section 14.– Provided further that before passing No person shall also take part in the any order under this sub-rule or under publication of any adver tisement the first proviso thereto. shall detain the thereof within ten days of the receipt of consignment and dispose it of in the notice. he for the purpose by the Central shall return the consignment or portion Government. the address of such to him within one week of the date of registered medical practitioner or the order and has given an undertaking wholesale or retail chemist being given. as the case may be: Drugs for Treatment of Disease. in writing not to dispose of the Such document shall bear at the top. SIDDHA AND UNANI MEDICINES nature referred to in section 6. accordance with the provisions of the Sea Customs Act. 1878 (VIII of 1878). AIDS . the Customs hospital or a laboratory”]. “For the use only of consignment when so required to do by registered medical practitioners or a the Customs Collector. or condition has given an undertaking under the first specified in the Schedule annexed to proviso to sub-rule (1) is required by these rules. he may the Customs Collector to return the and if requested by an officer appointed consignment or any portion thereof. mitigation. the words. treatment or prevention of (2) If the importer or exporter who any disease. shall exporter feels aggrieve by an order be sent by post to a registered medical passed by the Customs Collector under practitioner by name or to a wholesale this sub-rule and makes a representation or retail chemist. etc. and shall may be sent Confidentially. [5] [Manner in which Advertisements and the rules made thereunder. the Customs referring to any drug in terms which Collector shall consult the officer suggest or are calculated to lead to the appointed for the purpose by Central use of that drug for the diagnosis. consignment without the consent of the printed in indelible ink in a conspicuous Customs Collector and to return the manner. SCHEDULE (See Rule 6) 1. Government. disorder. Collector shall pass an order making over the consignment to the importer or [6] Prohibition of Advertisement of exporter.

I 1. Frt. Dhanyaka (Frt. Goksura (Rt. Bibhitaka (Frt. Asvattha (Bk. 23.) Cassia fistula Linn. Goksura (Frt. Haritaki (Frt. Atasi (Sd. 4.) Coriandrum sativum Linn.) Terminalia chebula Retz. 12.) Gmelina arborea Roxb 25. Monographs Published in MONOGRAPHS Ayurvedic Pharmacopoeia of India PART-I. Ativisa (Rt. 8.) Aconitum heterophyllum Wall. Kampilla (Frt. 33. 31. Guggulu (Exudate) Commiphora wightii (Arn. 35. Kancanara (St.) Myristica fragrans Houtt.) R. Bk. Amalaki (Drd. Asana (Ht.) Kurz. ex Del.Bk.) Sw.-Arg.) Ficus religiosa Linn.) Tinospora cordifolia (Willd.) Miers. Bk.) Bhand. Guduci (St.) Terminalia belerica Roxb.) DC. 5.) Lepidium sativum Linn. 19.) Abutilon indicum (Linn. 7. Bk. Jatiphala (Sd.) R. 22. 26. Amalaki (Fr. 36. Atibala (Rt. Arka (Rt. Dhataki (Fl. 13.) Woodfordia fruticosa (Linn. 18. ex Royle 15. 6. 9. 21. Candrasura (Sd.) F.) Apium leptophyllum (Pers. Bakuci (Frt. Hingu (Oleo-Gum-Resin) Ferula foetida Regel.) Withania somnifera Dunal.) Linum usitatissimum Linn. Br. Pulp. Babbula (St. 30. 28. 17. Eranda (Rt. Asvagandha (Rt.M.) Cleome gynandra Linn.) Pterocarpus marsupium Roxb. Jatamansi (Rz.) Acacia nilotica (Linn.) Plumbago zeylanica Linn. 2. Br.) Willd. Gunja (Sd. 32. Pulp) Aegle marmelos Corr. 11. 24. 20. Bilva (Frt. sp. Ajamoda (Frt. indica (Benth.) Ricinus communis Linn. Haridra (Rz.Wd. 3.) Saraca asoca (Rosc.) Tribulus terrestris Linn.) Calotropis procera (Ait.) Emblica officinalis Gaertn. Gambhari (Rt.) Abrus precatorius Linn. Ajagandha (Sd.) Curcuma longa Linn.) Brenan 16.) Bauhinia variegata Blume .) Nardostachys jatamansi DC. Citraka (Rt. 29. 34. ex Benth. Pulp)Emblica officinalis Gaertn. VOL. Ashoka (St.) Mallotus philippinensis Muell. Frt.) Tribulus terrestris Linn. Willd. Arka (Lf.) Psoralea corylifolia Linn. 14. 27.V.) Calotropis procera (Ait. 10. Aragvadha (Frt.

) Ficus racemosa Linn. Kustha (Rt.) Boerhaavia diffusa Linn.) Phyllanthus fraternus Webst.) Bergenia ciliata (Haw. 80.) Solanum surattense Burm. Karanja (Sd. Ketaki (Rt. Tvak (Bk.) Nees & Eberm. 38.) Adhatoda vasica Nees 77. 70. 41. Karkatasrngi (Gall) Pistacia chinensis Burgo 43. Krsnajiraka (Frt. 50. SIDDHA AND UNANI MEDICINES 37. ex Parkinson 46.) Hedychium spicatum Ham. Nyagrodha (St. Svetajiraka (Frt. 59. & M. 54.P. 40.-Ham.Perry 53. 44.) Walp. f.P.P.) Acacia catechu (Linn.) Sprague ex Turril . 48. Vijaya (Lf.) Euphorbia neriifolia Linn. Pasanabheda (Rz. Misreya (Frt. 64.) Holarrhena antidysenterica (Roth) A.) Cissampelos pareira Linn.) Keay 55. 78.) Ficus bengalensis Linn. 75. 52. Puga (Sd. Varuna (St.-Ham. f.-Ham.) Trachyspermum ammi (Linn. 58.) Merr. & Rt.) Glycyrrhiza glabra Linn. Tamalaki (Rt.) Valeriana wallichii DC.) Saussurea lappa C. Kantakari (W. Kutaja (St.) Maton 65. Karavira (Lf. 71. Kankola (Frt.) R. Kaseru (Rz.) Aloe barbadensis Mill.B.) Crataeva nurvala Buch. 60. Sunthi (Rz. 68. Kulattha (Sd.) Hemidesmus indicus (Linn.) Cassia angustifolia Vahl. 76. Clarke 51. Upakuncika (Sd. 57.) Elettaria cardamomum (Linn. Bud) Syzygium aromaticum (Linn. 62. St. Snuhi (St.. Saptaparna (St. 49. Madana (Frt. Punarnava (Rakta) (W. & Lf. 73.) Vigna unquiculata (Linn.) Carum carvi Linn. Sati (Rz. 79. 56. Bk. Vasa (Lf.102 LEGAL STATUS OF AYURVEDIC.) Swertia chirata Buch. 39. Suksmaila (Frt. 67. Patha (Rt. Yasti (St. Vidanga (Frt.) Cannabis sativa Linn. 66.) Alstonia scholaris (Linn. Khadira (Ht.) Cuminum cyminum Linn.f. 42. 61.) Willd. 74.) Nigella sativa Linn. Bk.) Cinnamomum zeylanicum Blume 72.) Pandanus tectorius Soland. Svarnapatri (Lf. Bk.) Foeniculum vulgare Mill.) Scirpus kysoor Roxb. Kanyasara (Lf. DC.) Nerium indicum Mill. Br.) Pongamia pinnata (Linn.) Piper cubeba Linn. 47. Udumbara (Bk.) Symplocos racemosa Roxb. f.) Sternb. 45. Tagara (Rz. Lodhra (St. 69.) Zingiber officinale Roxb.) Xeromphis spinosa (Thunb.) R.) Gossypium herbaceum Linn. Sveta Sariva (Rt.) Embelia ribes Burm. Kiratatikta (W. Br. Tvakapatra (Lf. ex Smith 63.Wd. Lavanga (Fl. Bk. Bk. Karpasa (Sd.) Merr. Yavani (Frt.) Areca catechu Linn.) Cinnamomum tamala (Buch.

) Abrus precatorius Linn. Katuka (Rz. SIDDHA AND UNANI MEDICINES 103 PART-I. Apamarga (W.Bk.) Achyranthes aspera Linn.) Leucas cephalotes Spreng. Iksu (St.) Clitoria ternatea Linn. Gajapippali (Frt. 9. 22. 32. Kozuppa (W.P. 12.) Anthocephalus cadamba Miq. Kokilaksa (W. Jambu (Sd.) Citrullus colocynthis Schrad.) Solanum nigrum Linn. Kokilaksa (Rt.) Merr.P.) Celastrus paniculatus Willd. Brahmi (W.) Portulaca oleracea Linn. 3. f.) Merr.) Kurz.) Picrorhiza kurroa Royle ex Benth. 14. Gunja (Rt. Brhati (Rt. 24.& A. 33.) Pongamia pinnata (Linn. 5.Pulp) Feronia limonia (Linn.) Merr. LEGAL STATUS OF AYURVEDIC.P. 15. Indravaruni (Rt. 41. 2. Daruharidra (St. Kokilaksa (Sd.Bk.) Piper retrofractum Vahl.) Pongamia pinnata (Linn.Bk.) Swingle 34.Bk. 11. Indravaruni (Lf.) Syzygium cuminii (Linn. Arjuna (St.) Semecarpus anacardium Linn.) Croton tiglium Linn.) Wettst.) Eclipta alba Hassk.) Merr.P.) Anacyclus pyrethrum DC. Dronapuspi (W.) Zingiber officinale Rosc.) Cucumis melo var. Aparajita (Rt. Kadamba (St. Gangeru (St. 19.) Skeels 26. Amrata (St. 23.P.) Pongamia pinnata (Linn. Jayanti (Lf.) Syzygium cuminii (Linn. Bhrngaraja (W. Frt. VOL.) Momordica charantia Linn. 35. 31. Gambhari (Frt. 8. 30.) Grewia tenax (Forsk.) Nelumbo nucifera Gaertn. 39. Dadima (Sd. 28. 25.) Saccharum officinarum Linn. 21. 16.Bk. Karanja (Lf.) Juglans regia Linn.) Gmelina arborea Roxb.) Sesbania sesban (Linn.) Scindapsus officinalis Schoott. 40.) Carissa carandas Linn. Ervaru (Sd. 36.Bk. Bhallataka (Frt.P.) Citrullus colocynthis Schrad.) Berberis aristata DC. 20.) Merr. Kapittha (Frt. 10. utilissimus Duthie & Fuller 18.) Bacopa monnieri (Linn. Karanja (Rt. Bk. Karavallaka (Fr. Jyotismati (Sd. 38.) Asteracantha longifolia Nees 42. Karanja (St. Karanja (Rt.) Spondias pinnata (Linn. Karamarda (St. Cavya (St. II 1. 6.) Punica granatum Linn. 7. Akarakarabha (Rt.) Terminalia arjuna W.) Aschers & Schwf. 13.Bk. 37.) Pongamia pinnata (Linn. Aksoda (Cotldn. Jambu (St.) Asteracantha longifolia Nees 44.) Acacia leucophloea Willd.) Solanum indicum Linn. 4. Jayapala (Sd. Arimeda (St. Ardraka (Rz.) Asteracantha longifolia Nees 43.) Skeels 27. 29. 17. Kamala (Fl. Kakamaci (W.Bk.P. .

Paribhadra (St. Methi (Sd.) Amomum subulatum Roxb.P. 7.) R.) Acorus calamus Linn.) Marsdenia tenacissima Wight. Priyangu (Infl.) Indigofera tinctoria Linn. III 1.) Kurz. Tulasi (Lf.) Alternanthera sessilis (Linn. Mura (Rt. PART-I. Saptala (W. 77. Yava (Frt. 75. 4. Bk.) Erythrina indica Lam. Tejovati (St.) Calotropis procera (Ait.) Kuntze 59. Arka (St. Vaca (Rz.) Ocimum sanctum Linn. 52. Sankhapuspi (W. Br.) Indigofera tinctoria Linn.Bk. SIDDHA AND UNANI MEDICINES 45. Sigru (Lf. 60. Adhaki (Rt.) Clerodendrum phlomidis Linn. & Arn. 61.f.) Anethum sowa Roxb. Plaksa (St. Tulasi (W. 66.) Raphanus sativus Linn.) Euphorbia dracunculoides Lam. Juss. Nagakesar (Stmn.) Callicarpa macrophylla Vahl.) Spondias pinnata (Linn. 48.P. 64.P.) Pueraria tuberosa DC. Nimba (Lf. 9.) R. Pippalimula (St. Juss. 62.) Desv.) Mesua ferrea Linn.Bk. 51.) Piper longum Linn. 70. 72. Sthulaela (Sd.Bk.) Hibiscus sabdariffa Linn. Murva (Rt.) Zanthoxylum armatum DC. Lajjalu (W.) Cajanus cajan (Linn. 46. Yavasaka (W. Bk. 47. Agnimantha (Rt.) Madhuca indica J. Sali (Rt.) Mangifera indica Linn.) Butea monosperma (Lam. VOL. 54. ex Flem.P) Alhagi pseudalhagi (Bieb. Mulaka (W.) Selinium candollei DC. Nili (Rt.) Azadirachta indica A. 6. Prasarini (W.P. 55. Amra (St. 3. 68.) Paederia foetida Linn.) Mangifera indica Linn. 49. Ambasthaki (Rt. Priyala (Sd.P. f.) Mimosa pudica Linn. Vatsanabha (Rt.) Ocimum sanctum Linn. Palasa (St. Bk. Apamarga (Rt.F.) Achyranthes aspera Linn.) Trigonella foenum-graecum Linn.) Moringa oleifera Lam.) Millsp.) Raphanus sativus Linn.-Ham. 2. Amrata (St. . 8.) Ficus lacor Buch.P. 71.P. 63.Bk. 57. Vidari (Tub. 69. 5.) Aconitum chasmanthum Stapf ex Holmes 76. Araluka (St. 56.) Oryza sativa Linn. Gmel.) Buchanania lanzan Spreng. 58. Mulaka (Rt. 78. 73. Madhuka (Fl.Rt.) Convolvulus pluricaulis Choisy 67.Bk.) Azadirachta indica A.104 LEGAL STATUS OF AYURVEDIC. Amra (Sd. 53. Matsyaksi (W. 74. Satahva (Frt. 50. Br. Nili (Lf. Nimba (St.) Ailanthus excelsa Roxb. 65.) Hordeum vulgare Linn.

Kola (Frt. Masaparni (W. Jati (Lf.) Luffa acutangula (Linn.) Gloriosa superba Linn. Masura (Sd.) Mucuna prurita Hook. 18.) Gmelina arborea Roxb. Don 38. 34.) Holoptelea integrifolia Planch 19.) Teramnus labialis Spreng. 21. 51. 52.) Vitis vinifera Linn. 50. Dhattura (Sd. Bharangi (Rt.) Coccinia indica W.P. Kusa (Rt.) Zizypus jujuba Lam.) Pers. 35. 22. 42. 17.) Oxalis corniculata Linn. 20. SIDDHA AND UNANI MEDICINES 105 10. 53.) Lens culinaris Medic. 28.) Ricinus communis Linn.) Juniperus communis Linn. Mahabala (Rt.) Rubia cordifolia Linn. & A.) Ricinus communis Linn. ex D. Kadali (Rz. 33. Kamala (Rz. Cirabilva (Frt. 24. Cangeri (W. 36.P. Pt. Bijapura (Frt. Hamsapadi (W.) Musa paradisiaca Linn.) Nymphaea alba Linn. Marica (Frt. Stock) Saccharum spontaneum Linn. Bilva (Rt. 32. 49.) Baliospermum montanum Muell-Arg. Karavira (Rt.) Nelumbo nucifera Gaertn. 45. Eranda (Lf. 40. Draksa (Frt. Katphala (Frt.) Carissa carandas Linn. Kakoli (Tub.P. Kakajangha (Rt.) Lilium polyphyllum D. Don 44. Karinkara (Rt. 16. Kumuda (Fl. . Durva (Rt. Br. 54. 23. Danti (Rt. Manjistha (St. LEGAL STATUS OF AYURVEDIC. Bk. Asthisamhrta (St.) Aristolochia indica Linn. Kola (St.) Datura metel Linn. Hapusa (Frt. 39. Kasa (Rt. 47. Kosataki (W.-Ham.) Cynodon dactylon (Linn.) Nerium indicum Mill. 55. 27. Atmagupta (Sd.) Cissus quadrangularis Linn.P. Gambhari (St.) Desmostachya bipinnata Stapf. 15. Eranda (Sd. Bimbi (W. 48. Pulp) Zizypus jujuba Lam. Granthiparni (Rt. 13.) Sida rhombifolia Linn.) Adiantum lunulatum Burm 29.P. Rt.) Holarrhena antidysenterica Wall. 30. 31. Don 43.) Clerodendrum serratum Linn. 37. Bk.) Citrus medica Linn. 26.) Myrica esculenta Buch.) Myrica esculenta Buch.) Roxb. St. Katphala (St.) Pterocarpus marsupium Roxb.-Ham. Indrayava (Sd.) Jasminum officinale Linn. Asana (St. ex D.) Aegle marmelos Corr. Indravaruni (Frt.) Martynia annua Linn. 14. Isvari (Rt. 11.) Citrullus colocynthis Schrad. 12.) Peristrophe bicalyculata Linn.) Onosma bracteatum Wall. Kakanasika (Sd. Langali (Rz. 25. 46.) Leonotis nepetaefolia R.) Piper nigrum Linn. Bk. Lasuna (Bulb) Allium sativum Linn. 41. Gojihva (Aer.

) Desmodium gangeticum DC. Nirgundi (Lf. Simsapa (St.) Pterocarpus santalinus Linn. Musta (Rz. Munditika (Lf. Satapatrika (Fl. Padmaka (Ht.) Prunus cerasoides D.) Cyperus rotundus Linn.) Ficus hispida Linn. Sarala (Ht. 90.) Ach.) Cocos nucifera Linn. 84. 63. Salaparni (Rt.) Barleria prionitis Linn.) Ficus hispida Linn. Sthauneya (Lf. 60.) Pinus roxburghii Sargent 85. Tala (Infl. Sana (Sd. 99.106 LEGAL STATUS OF AYURVEDIC. Saileya (Lichen-‘Thallus’) Parmelia perlata (Huds. 88.) Oroxylum indicum Vent.) Pluchea lanceolata Oliver & Hiem. 87.) Piper betle Linn.) Brassica campestris Linn.) Vitex negundo Linn. Mudga (Sd. Wd.) Cassia tora Linn. Svetacandana (Ht. Don 66. 74. SIDDHA AND UNANI MEDICINES 56.) Amorphophallus campanulatus (Roxb. P. Ramasitalika (W.) Standl. Wd.P. Salmali (St. 78.Wd. Phalgu (Rt. Prapunnada (Sd.) Oryza sativa Linn. Nagavalli (Lf.) Pinus roxburghii Sargent 86. Surana (Corm.) Phaseolus radiatus Linn.) Rosa centifolia Linn. Narikela (Endo. Nili (W. 71. Sahacara (W. 69.) Indigofera tinctoria Linn.) Vetiveria zizanioides (Linn. 58. 70. Simsapa (Ht. 89. 76. 79. Sara (Rt. Trivrta (Rt.) Bl. 73.) Raphanus sativus Linn. 83.Bk. Sali (Frt. 72.) Amaranthus tricolor Linn.) Taxus baccata Linn.Wd. 91. 98. Sarala (Rt.) Dalbergia sissoo Roxb. Utpala (Fl. 96. 61. 59. 93. Syonaka (Rt. Raktacandana (Ht. Wd. 65.P. Sarsapa (Sd.) Lagenaria siceraria (Mol. Patalai (Rt. 57. Sakhotaka (St.) Streblus asper Lour. Nicula (Frt. Udambara (Frt.) Nymphaea stellata Willd . 62. Phalgu (Frt.) Operculina turpethum (Linn. Rasna (Lf. 95.) Ficus glomerata Roxb. Bk. Wd.) Santalum album Linn. 80.) Stereospermum suaveolens DC. 77.) Crotolaria juncea Linn.) Saccharum bengalense Retz.) Borassus flabellifer Linn. Raktapunarnava (Rt. 82. Sahadevi (W. Saka (Ht.P.) Gaertn. Bk.) Albizzia lebbeck Benth. Sirisa (St. Bk. 92. 75.) Silva Manso 97. Usira (Rt.) Boerhaavia diffusa Linn.) Sphaeranthus indicus Linn. 94. 81.) Nash 100. 68.) Dalbergia sissoo Roxb. Mulaka (Sd.) Barringtonia acutangula (Linn. Tumbini (Frt.) Vernonia cinerea Lees. 67.) Bombax ceiba Linn. 64.) Tectona grandis Linn.

) Citrus limon (Linn.P. Nirgundi (Rt.P. Bk.) Michelia champaca Linn. 21. f. LEGAL STATUS OF AYURVEDIC. Nayagrodha Jata (Ar. 43. 40. 11. Palasa (Sd. 33.) Sphaeranthus indicus Linn. VOL. Mudgaparni (W. 8.) Lodoicea maldivica Pers. Aklari (Endm. 2. 25. 12.) Lawsonia inermis Linn. Kasturilatika (Sd. 18.) Crocus sativus Linn. Atmagupta (Rt. Bilva (St. 28. 20.F. 24. Krsnasariva (Rt. Kunkuma (Sty.P. 19.) Strychnos potatorum Linn.) Urban 30. Nimbu (Fr. .) Musa paradisiaca Linn. 27.) Ficus lacor Buch. 16.) Aegle marmelos Corr.P. Durva (W.) Burm. Aparajita (Lf. & Schult. Palasa (Fl.) Stereospermum chelonoides (L. 4.) Caesaplinia sappan Linn.P. Mandukaparni (W. 26. Dadima (Ft. Cinca (Ft.) Clitoria ternatea Linn.) Vigna trilobata (Linn. Bk.) Gmelina arborea Linn. Bk.) Punica granatum Linn. Dhattura (W. 22. Mayakku (Gall) Quercus infectoria Oliv. Plaksa (Ft. 37. Dadima (Lf.) Curcuma zedoaria Rosc.) 15.) Vitex negundo Linn. Iksu (Rt. Wd. Pl. Dadima (Fr.) Cynodon dactylon (Linn. Ft. Devadaru (Ht. 10. Mahanimba (St.) Verdc. Bk.) Cryptolepis buchanani Roem. Wd. Kunduru (Exud.) Aquilaria agallocha Roxb. IV 1. 41. Ft. Pattanga (Ht. Kataka (Sd. Rt. 42.) Hibiscus abelmoschus Linn. 38.) Boswellia serrata Roxb.) Melia azedarach Linn.) Phoenix dactylifera Linn.) Cajanus cajan Linn. 44. Priyala (St. & Stg. 39.) Piper longum Linn. Fruit) Punica granatum Linn. Rind) Punica granatum Linn.) Benincasa hispida (Thunb. 5. f.) Butea monosperma (Lam. Kharjura (Fr.) Cogn. 29. 32. Wd. Stock) Saccharum officinarum Linn.) Centella asiatica (Linn. Pippali (Ft. Madayanti (Lf. 6. Ft. Adhaki (Sd.) Tamarindus indica Linn. 7. Gambhari (St.) Datura metel Linn.) Mucuna prurita Hook. 17.)DC. Patalai (St. 14. 9. Kharjura (Drd.) Kuntze. 13. 34.) Phoenix dactylifera Linn.) Loud.P. Kadali (Fl. 23. 36. 31. Parpata (W.) Kuntze. Champaka (Fl. 3. Munditika (W.) Buchanania lanzan Spreng. SIDDHA AND UNANI MEDICINES 107 PART-I.) Fumaria parviflora Lam. 35. – Ham. Kusmanda (Ft. Karcura (Rz. Palasa (Gum) Butea monosperma (Lam. Bk. Agaru (Ht.) Ficus bengalensis Linn.) Butea monosperma (Lam.) Cedrus deodara (Roxb.) Kuntze.

Srngataka (Drd. 7.) Imperata cylindrica (Linn. Satavari (Rt.) Ocimum sanctum Linn.) Sesamum indicum Linn. 15. Aragvadha (St. Sruvavrksa (Lf. 67.) Cassia fistula Linn. Sigru (St. Bk) Flacourtia indica Merr. 66. 64. 3. Talisa (Drd.f.) Strychnos nux-vomica Linn.) Vallaris solanacea Kuntze 6.) Blepharis persica (Burm. Tila (Sd. K.) Moringa oleifera Lam. Ankola (Lf.) Fagonia cretica Linn. 56. 65. Amra Haridra (Rz. Gavedhuka (Rt. Tulasi (Sd.Bk. Utingana (Sd. 50. 57.) Zanthoxylum armatum DC.) O. 13. 54.) Beauv. 46. Ghonta (Fr. 58.f.Bk.) Tragia involucrata Linn.) Coix lachryma-jobi Linn. Bk.Pl. VOL.) Moringa oleifera Lam. 16. Varahi (Rz. Dhanvayasa (Wh.) Coleus forskohlii Briq. Darbha (Rt. Yava (W.) Inula racemosa Hook. Vasa (Rt. 51. Sigru (Sd.) Angelica archangelica Linn. 19. Stock) Angelica glauca Edgw. Prsniparni (W. Gandira (Rt. 17. Vrscikalli (W.) Flacourtia indica Merr. Talamuli (Rz. 5.) Jatropha glandulifera Roxb. & Rt.) Abies webbiana Lindl. 68.108 LEGAL STATUS OF AYURVEDIC.) Hordeum vulgare Linn.) Adhatoda zeylanica Medic.) Asparagus recemosus Willd.f.) Elaeocarpus sphaericus Gaertn. Dugdhika (Wh. Lf. Saraja (Exud. 4. 12. Sigru (Rt.) Uraria picta Desv. Tumburu (Ft. 11.P. f. 62. 48.) Trianthema portulacastrum Linn.) Alangium salviifolium (Linn. Canda (Rt.P.f. Anisoon (Fr.) Capparis spinosa Linn. Priyangu (Fruit) Callicarpa macrophylla Vahl.) Boj. 47. 10.P. Rudraksa (Sd.) Prunus avium Linn. Bhurja (St.) Vateria indica Linn. Dravanti (Sd. SIDDHA AND UNANI MEDICINES 45.Pl.) Curculigo orchioides Gaertn. Gundrah (Rz. Visamusti (Sd.) Typha australis Schum. Bk) Moringa oleifera Lam. . 9. Bastantri (Rt.Don 8. Sruvavrksa (St. Coraka (Rt. Ait. V 1. Kuntze. 53. and Thonn. & Rt. 63.) Pimpinelia anisum Linn. 60. PART-I. 52. Varsabhu (Rt. Asphota (Rt. 2.) Curcuma amada Roxb.Sd) Trapa natans Linn. Schum 49.) Betula utilis D. 18. Himsra (Rt. 59.) Euphorbia prostrata W.) Ziziphus xylopyrus Willd.) Dioscorea bulbifera Linn.) Wang. 55. Elavaluka (Sd. 61. 14. Puskara (Rt.) Argyreia nervosa (Burm.

) Cardiospermum halicacabum Linn.) Typha elephantina Roxb.) Ficus arnottiana Miq. Palas (Fl. 48. 55.) Alpinia galanga Willd. Mesasrngi (Rt.) Polygonatum cirrhifolium Royle 47.) Butea monosperma (Lam. 40. Kodrava (Grain) Paspalum scrobiculatum Linn. Kakajangha (Sd. 31.) Butea monosperma (Lam. 30.Br. Nimba (Fr.) Papaver somniferum Linn.) Sesbania bispinosa W. 65.-Ham.) Gaertn. 62.) Smith.Pl. 35.) Kuntze 59. Karnasphota (Rt. Nandi (Rt.) Gymnema sylvestre R.) Salvadora persica Linn. Pattura (Wh. Jivak (Pseudo-bulb) Malaxis acuminata D. Pilu (Fr.Bk.Rt.) Thespesia populnea (L. Wd. Palas (Sd. Itkata (Rt. 32. 56. Kshiravidari (Rt. 54.) Hyoscyamus niger Linn.) Gymnema sylvestre R.Bk. Karnasphota (Sd. Kakanaja (Fr.) Careya arborea Roxb. Mahameda (Rz. Latakaranja (Sd. 41.Br. Khaskhas (Sd.Juss. Lavaliphala (Fr. Khubkalan (Sd.) Peristrophe bicalyculata (Retz. Medasakah (St. 50. 44. Khatmi (Sd. Kapitan (St.Bk.F.&Rt.) Kuntze 60.) Ferula jaeschkeana Vatke 21. 43. Kadara (Ht. 61.) Ipomoea digitata Linn.Pl.) Skeels 45. Medasakah (Wd. Pilu (Rt.) Althaea officinalis Linn. Khatmi (Rt.Pl. 57. 53. Maramanjal (Rt.) Eleusine corocana (L. Nimba (Rt.) Stapf 33.) Althaea officinalis Linn. 26. 49. SIDDHA AND UNANI MEDICINES 109 20. Ksirakakoli (Bulb) Fritillaria roylei Hook.) Coscinium fenestratum (Gaertn. Madhulika (Rt. Karkash (Rt.) Phyla nodiflora Greene 24.) Caesalpinia bonduc (Linn.) Sisymbrium irio Linn. Parasikayavani (Sd. 63. Nimba (Fl. ex Willd.) Phyllanthus acidus (Linn. 38.) Cardiospermum halicacabum Linn. 42. 39.) Colebr. ex Correa 29.) Azadirachta indica A.F. & St.) Salvadora persica Linn.Juss.) Barleria strigosa Willd. 58.Wight 22.) Azadirachta indica A.) Cymbopogon citratus (DC.) Azadirachta indica A. Hingupatri (Lf. 51. 34. Pilu (Lf.) Juss. Jalpippalika (Wh. Kumbhikah (Sd.) Smilax china Linn.) Costus speciosus (Koerning ex Retz.) Acacia suma Buch.Don 25.) Sesbania bispinosa W.) Litsea chinensis Lam. Potagala (Rt.Wight 23. 28. Mahdusnuhi (Tub.) Nees 27. 46. Kattrna (Wh.) Physalis alkekengi Linn. 36. 37. Itkata (St.) Salvadora persica Linn.) Aerva lanata (Linn. LEGAL STATUS OF AYURVEDIC.Juss. Kulanjan (Rz. .) Soland.) Momordica dioica Roxb. Mesasrngi (Lf. Kebuka (Rz.) Roxb. 64.Bk.) Litsea chinensis Lam. 52. Nilajhintika (Rt.

83. Tuni (St.) Centratherum anthelminticum (L.) Cucumis sativus Linn. Pullani (Lf. Rumimustagi (Resin) Pistacia lentiscus Linn.) Dendrophthoe falcata (Linn. Pudina (Aerial Part) Mentha viridis Linn.) Ettingsh. Vanda (Fr. 86.) Capparis horrida Linn.) Trichosanthes bracteata (Lam.f. 68.Bk.) Caesalpinia crista Linn. Putikaranjah (St. 72. 85. Vanda (Aerial Rt. Sarala (Exudate) Pinus roxburghii Sargent 76.) Voigt 92. 70. ex Kurz 77. Riddhi (Tuber) Habenaria intermedia D. Visala (Rt.f.) Ettingsh.f.110 LEGAL STATUS OF AYURVEDIC. 80.) Wats 74. Vidarikand (Tuber) Pueraria tuberosa DC. Vanda (Lf. Sarpagandha (Rt. Vyaghranakhi (Fr.Bk.) Benth.) Calycopteris floribunda Lam.) Boerhaavia verticillata Poir. 71.) Rauwolfia serpentina (Linn.) Cedrela toona Roxb. Pullani (St.) Dendrophthoe falcata (Linn.) Ettingsh. 88.) Kuntze 89. Pullani (Rt. Virala (St. 69.) Diospyros exsculpta Buch. Tailaparna (Lf. Tintidika (Aerial Part) Rhus parviflora Roxb. 82.Don 73.) Eucalyptus globulus Labill.) Cymbopogon martinii (Roxb.) Calycopteris floribunda Lam.) Dendrophthoe falcata (Linn. Rohisa (Wh. 75.) Hochr.) Calycopteris floribunda Lam. 78.f. 87.Pl.f.) Dendrophthoe falcata (Linn.) Ettingsh. 91.-Ham. Tinisha (Wd.) Ougeinia oojeinensis (Roxb. Vanda (St. SIDDHA AND UNANI MEDICINES 66. 81. 90.) Vitex negundo Linn.) Dendrophthoe falcata (Linn. 67. Renuka (Fr. Svetapunarnava (Rt. Trapusa (Sd. Vanyajiraka (Fr.Bk.) Ettingsh. . 84. Vanda (Fl. 79.

Khar-e-Khasak Khurd Tribulus terrestris Linn . 23. Aak Calotropis Procera (Ait). 10. Katan Linum usitatissimum Linn.) Maton 17. Fufal Areca catechu Linn. Kamila Mallotus philippinensis Muell. Baobarang Embelia ribes Burm. Royle 6. Arg. Darchini Cinnamomum zeylanicum Blume 13. Ham. 21. 22. Halela Zard Terminalia chebula Retz 16. 24. Syn. 15. Badiyan Foeniculum vulgare Mill 8. Phyllanthus emblica Linn. 5. LEGAL STATUS OF AYURVEDIC. Balela Terminalia belerica Roxb 9.Br. Atees Shireen Aconitum heterophyllum Wall ex. Aamla Emblica officianalis Gaertn. Kaner Nerium indicum Mill. Asgand Withania somnifera Dunal. Gilo Tinospora cordifolia (Wild) Miers. Kababchini Piper cubeba Linn 20. R. Ferula narthex Boiss 18. Hilteet Ferula foetida Regel. 2. 12. 7. Asl-us-Soos Glycyrrhiza glabra Linn.f. 14. Kalonji Nigella sativa Linn. Karanj Pongamia pinnata (Linn) Merr. Belgiri Aegle marmelos Corr. I 1. 4. Jauzbuwa Myristica fragrans Houtt 19. Babchi Psoralea corylifolia Linn. Chiraita Swertia chirata Buch. 3. VOL. SIDDHA AND UNANI MEDICINES 111 Monographs Published in Unani Pharmacopoeia of India PART-I. 25. 11. Heel Khurd Elettaria cardamomum (Linn.

Post-e-Gular Ficus racemosa Linn. Syn. Muqil Commiphora wightii (Arn. Pambadana Gossypium herbaceum Linn. SIDDHA AND UNANI MEDICINES 26. 30. Tagar Valeriana wallichii DC 43. Sumbul-ut-Teeb Nardostachys jatamansi DC 42. Zeera Siyah Carum carvi Linn. Zard Chob Curcuma longa Linn. Kishneez Coriandrum sativum Linn 28. Sheetraj (Hindi) Plumbago zeylanica Linn. & L. Perry 35. Balsamodendron mukul Hook ex stocks 32. Zanjabeel Zingiber officinale Roxb 44. Kulthi Vigna unquiculata (Linn. 31. Mainphal Xeromphis spinosa (Thunb) Keay. Syn.) Bhand. Ham. .) Merr. Qaranful Syzygium aromaticum (Linn. Randia dumetorum Lam.M. 45. Qust Saussurea lappa C. 36. Sazaj Hindi Cinnamomum tamala (Buch. 27. 34. 29. ex Linn.) walp syn. Syn. 41. Aloe vera Tourn. Clarke 37. Sana Cassia angustifolia Vahl 38. Qinnab Cannahis sativa Linn.112 LEGAL STATUS OF AYURVEDIC. Dolichos biflorus Linn. Sibr Aloe barbadensis Mill. 33.) Nees & Eberm 39. Lodh Pathani Symplocos racemosa Roxb. Khiyar Shambar Cassia fistula Linn. 40.B.

Hengrabari. The Director. Dispur. Directorate of Health Services. 4. Panji-403001.M. Government of Assam. Dr. Naharlagun-791110 (Arunachal Pradesh). Directorate of Health Services. . 3. Directorate of Health Services. Secunderabad-500003 (Andhra Pradesh).C. Sector 7-C. 1st Floor. 5. Old G. The Drug Controller. Gandhinagar-382010. Madhya Marg. Food & Drugs Administration. Chandigarh-160007 (Haryana). Karol Bagh. SCO No. Guwahati-6 (Assam). Raipur. The Drug Controller. The Commissioner. Jivraj Mehta Bhawan. The Director (ISM&H). Chhatisgarh. 7. Government of Arunachal Pradesh. Block-8. The Drug Controller. 6. The Commissioner (ISM&H) & Licensing Authority. The Licensing Authority-cum-Director (Ayurveda). Building. New Secretariat. Vikas Bhawan. Clock Tower. Food & Drugs Administration. Addresses of State Drugs Controllers/Licensing Authorities under ISM&H 1. New Delhi-110005. Government of Haryana. 2. 9. Food & Drugs Control Administration. Government of NCT Delhi. 2-A. Government of Andhra Pradesh. The Drug Controller. Government of Goa. Patna-800015. Tibbia College. Government of Bihar. Gujarat. 4th Floor. Government of Gujarat. 8.

Kasumpati. 341. Government of Mizoram. Himachal Pradesh-171009. Public Health Laboratory Campus. Directorate of Health Services. SIDDHA AND UNANI MEDICINES 10. Deputy Drug Controller. Mumbai-400051. The Licensing Authority. Nepal House. Idgah Hills. Director of Health Services. Thiruvananthapuram-695037. Department of Health & Family Welfare. Ranchi (Jharkhand). Kohima-795001 (Nagaland). Government of Nagaland. Medical and Health Services. 26. Chaltlang. Bandra (East). Red Cross Road. . The Controller.O. Bangalore-560009 (Karnataka). Drug Controller & Licensing Authority. The Controller. Survey No. Government of Maharashtra. Shillong-793001 (Meghalaya). Government of Kerala. The Commissioner. 18. Government of Karnataka. 16. Dhanvantari Road. Janipur. P. Food & Drugs Administration. Drug Controller & Director. 20. Director (Ayurveda) & Licensing Authority. Doranda. Director of Health Services. 17. Aizawl-796012 (Mizoram). Directorate of ISM&H. 19. Assistant Director (Ayurveda).114 LEGAL STATUS OF AYURVEDIC. 13. Government of Manipur. Bhopal (Madhya Pradesh). 11. Jammu Tavi-180001. Government of Himachal Pradesh. Block No. Bandra Kurla Complex. Government of Jharkhand. Department of Health & Family Welfare. Food & Drugs Administration. Patoli Mangotrian. Imphal-795004 (Manipur). 12. Government of Meghalaya. Drugs & Food Control Organization. 15. 14.

A. Gangtok-737101 (Sikkim). Ayurveda & Unani Services. Government of Uttar Pradesh. Ajmer-305001 (Rajasthan). Bhubaneshwar-751001 (Orissa). Ashok Marg. Head of Department (Annexe Building). SIDDHA AND UNANI MEDICINES 115 21. Indira Bhawan. Lehgal Road. Drugs and Cosmetics Cell. Bose Road. Government of Rajasthan.C. Director (Ayurveda). Sector-34-A. 23. Director & Licensing Authority. Government of Tripura. Kunjaban. 29. Anna Salai. Chennai-600006. Tenampet. State Drug Controlling Authority. Directorate of Indian Medicine & Homoeopathy. Director. Director. 27. 258-261. 141. LEGAL STATUS OF AYURVEDIC. Government of Tamilnadu. Chandigarh-160015 (Punjab). Agartala-799006 (Tripura).J. The Licensing Authority. . 25. Sachivalaya. 9th Floor. Drugs Control. Government of Orissa. Directorate of Ayurveda. Government of Uttaranchal. 24. Assam Rifles Office Complex. Director of Ayurveda & Licensing Authority. Department of Health & Family Welfare. Dehradun (Uttaranchal). Controlling Authority & Deputy Drugs Controller. Department of Health & Family Welfare. Drug Controller. Government of West Bengal. Directorate of Health Services. Calcutta-700014 (West Bengal). Lucknow. Government of Punjab. 28. 22. 3rd Floor. 26.

Rishikul State Ayurvedic College. Ajmer. 10.. 5. Govt. Drug Testing Laboratory. Food & Drug Laboratory. Government Analyst Drug Testing Laboratory. Lucknow (UP). Supdt. Drug Standardization Unit. Government Ayurvedic & Unani Pharmacy. Uttaranchal.S. 32. Chief Supdt. Dy.R. Phone: 6216244. Maharashtra-431602. & Government Analyst. Drug Testing Laboratory. 9. . Principal/Supdt. Supdt. Haridwar. 7. Bhubaneshwar. P. S. Director. Phone: 0674-432347. Jayanagar. Govt. Arignar Anna Government Hospital of Indian Medicine Complex. List of Government Drug Testing Laboratories (Ayush) 1. Hyderabad-500077 (AP). Gujarat. Drug Testing Laboratory. Government Ayurvedic Pharmacy. 11.. 2. Sarojini Naidu Marg. 8. Government Central Pharmacy. Tamilnadu-106.. Pushkar Road. Nagarwartangi. Rajasthan. Chennai.O. Dean. 6214844. Poojappura. Karnataka. Ayurveda Drug Testing Laboratory. Kattedan. Government Ayurvedic Hospital. Indian Medicine Pharmacy (Ayu. Ayurvedic Research Institute. Incharge Drug Testing Laboratory. Distt. Arumbakkam. State Drug Testing Laboratory. Phone: 0133-427003. Orissa-751014. Phone: 01904-22048. Drug Testing Laboratory.). Manager. Dy. Thiruvananthpuram.O. Pharmacognosy Division. Ayurvedic & Unani Medicine. 3. Government Drug Testing Laboratory. Nanded. Joginder Nagar. Mandi-176120 (HP). 4. (Chemistry). Bangalore. 6. Kerala. BJB Nagar. Research Institute in ISM. Government Drug Testing Laborator y for ISM. Vadodara. S. Near Polytechnic. I-Block Near Ashoka Pillar. Vazirabad.O.

Central Medical Store. Assistant Director (ISM & H). Food & Drug Testing Laboratory. Health Ser vices. Haryana. Itanagar. Head. LEGAL STATUS OF AYURVEDIC. Director. Raipur. Kurukshetra. Old Press Road. Patiala. Drug Testing Laboratory (ISM). 22. Guwahati. Meghalaya-793001. Nodal Officer (ISM&H). Superintendent. SIDDHA AND UNANI MEDICINES 117 12.P. Supdt. Delhi. Pesteur Institute. Agartala. 16. 25. GE Road. Government Ayurvedic Pharmacy. Government Drug Testing Laboratory. NIPER. State Pharmacopoeial Laboratory & Pharmacy for Indian Medicine. Neheralagrum. Director (AYUSH). Central Pharmacy and Stores. Gwalior-474009. Principal and Incharge. Tripura-799006. Arunachal Pradesh. . Phone: 0361-2570455. Incharge. Government DTL (ISM). Drug Testing Laboratory (AYUSH). Government DTL (ISM). 18. Patoli. Lawrence Road Industrial Area. Government of Jharkhand. Controller. 19. 14.. Jammu-180007 (J&K). Shri Krishna Government Ayurveda College & Hospital. Government Ayurvedic Pharmacy Compound. Shillong. Phone: 50626281. Zamabawak. Director. 23. Kalyani. Government Drug Testing Laboratory for AYUSH. 26. Nehru Office Complex.) 15. Drug Testing Laborator y. Mangotrian. 20. Directorate of Health Services. Government of Nagaland. Incharge. Pt. Chhatisgarh. Drug Testing Laborator y of ASU Drugs. 13. A-20. Ranchi. Department of Natural Product. Incharge. Aizawl. Punjab. Government Ayurvedic College. Combined Food & Drug Laborator y. Health Ser vices. (M. Panjab-147001. Nadia West Bengal. Drug Controller. Aushadh Niyantran Bhawan. Nagaland. Drug Testing Laboratory of AYUSH. Director. Food & Drug Laboratory. Dy. State Drug Testing Laboratory (ISM). 21. 24. Kohima. Government Analyst. Mizoram. Mohali. State Drug Testing Laboratory for ISM Drugs. Amkho Lashkar. 17. Dy.

ARBRO Pharmaceuticals Ltd. 040-23202731 5-8-293/A. M/s. Fax: 080-28410189 8. Varun Herbals Pvt. Shriram Institute for Industrial Research. Ltd. Bangalore Test House. Bangalore. 5. M. Ltd. Jammu-180001.. 2. M. 040-23734720/ 407. (POST). Fax: 040-23202731 Hyderabad. Fax: 91-11-25463784 7. Name of the Laboratory Telephone & Fax 1. 4/9. Fax: 26214809 Arumbakkam.R. Fax: 040-23746871 3. Chirag Ali Lane. Vijayanagar.T. M. Ltd. 080-3336909.S.. Post Attur Via Yelahanka.. 9. Chennai-600098. Bangalore-560054.I. Bangalore-560048.S. Sowparnika Herbal Extracts & 26252590 Pharmaceuticals Pvt.No. . North Phase. Ramaiah Drugs and Allied Products Testing Laboratories. FRLHT. Captain Srinivasa Murti Drug Research Institute 040-26214823 for Ayurveda (CCRAS). 4. 080-28410172 Whitefield Road. 0191-2547850 6. M/s. 74/2 Jarakabande Kaval. 011-255457188. 65/20th Main Morenhalli. SIDCO Industrial Estate. Mahesh Nagar. Fax: 26521607 No. 0191-2547493 Canal Road. M/s. Ameetpet. Siddha & Unani Private Drug Testing Laboratories under Rule 160 A to J of the Drugs and Cosmetics Rules 1945 Sl. List of Approved Ayurveda. Jammu Tavi. 040-23746873 Hyderabad-500038. Regional Research Laboratory (CSIR). Chennai-600106. 0191-2544382.S. Adiya Enclave. Kirti Nagar Industrial Area. 011-25457923 New Delhi-110015. 31-A/2A. Sipra Labs Pvt. Ramaiah Nagar. 080-28410165 14 & 15 Sathyamangala Industrial Area. Fax: 0191-2543829. Nilgiri. Fax: 080-3334167 10. 080-3434465 Bangalore-560064..

Amol Pharmaceutical Pvt. Indore. Shriram Institute for Industrial Research. Arya Vaidyashala Kotakkal. 27667860 Fax: 9511-27667676 18.-485331. Sargam Metals Pvt. Research Laboratory Pvt. M/s. M. Rajwada.-452001. M/s.P. Shiv Vilas Place... 080-4020 9999. M/s. M/s. M. Anusandhan Analytical & Biochemical 0731-2534167. Ayurveda and Yoga Sciences.P. 0483-2742216. 86. SIDDHA AND UNANI MEDICINES 119 11. Indore. 69. Ltd. Ltd. Delhi. International Testing Centre 0172-2561543. 9511-27667267. 0172-2214695 Mohali. M/s. Functional Industrial Estate.. 25. Patparganj. 13. 0755-2573935.-452004. Rajasthan. 6/3. Plot No. NIPER. Ollur. 0487-2352398 19. Bangalore. M/s.) MIE. 265510 17. Indore. 435.-452004. Bahadurgarh. Ozone Pharmaceuticals Ltd.. Road. 01276-227137 Dist. Bhopal. 0141-2771132. LEGAL STATUS OF AYURVEDIC. Satna. M/s. Natural Remedies Pvt. Quality Control Laboratory. (Analytical Lab. 0172-256825 Panchkula Fax: 0172-2561543 24.P. 0141-2771150 Fax: 0141-2770744 . Jajjhar. 5054924 Indore. 4020 9703 Fax: 080-4020 9817 21. +91 731 2490592. Delhi-92.P. Sanganer Jaipur. J.. Industrial Estate. 01276-268037 12. 17. Chanidgarh. 16. 23. Chennai. 5070019 Fax:+91 731 2490593 15. 2493592/93. Malapuram. Ltd. 19 20. Standard Analytical Laboratory Pvt. Ltd. Choksi Laboratories Ltd. 14. Manoramganj. Ltd. University Road. Laboratories Service Division. Standard Analytical & Research Laboratories. Chitrakoot.P.D.. 0487-2352338. 01276-267792. 265623. Industrial Area.G. M. M. 265609.-462003. Laxmibai Nagar. M. Vaidya Rathnam. 0731-2412818 358/4. Thrissur. Aushadhshala. 0172-2214683 Fax: 0172-2214695 22. Drug Testing Laboratory. Fax: 0731-2410204 Kilamaidan. 5222448 M.R.. Tata Foundation for Research in 07670-265632. Malviya Nagar. 265353 Arogyadham (Deendayal Research Institute) Fax: 07670-265477. Haryana-124507. Phase-I.

NABL Accredited Laboratories

Delhi Test House, New Delhi
Address: Contact Details:
A62/3, G.T. Karnal Road Industrial Area Tel No. 011-27437327, 27435509
Opp. Hans Cinema, Azadpur, Fax No. 011-27435509, 27456917
New Delhi-110033, India. E-mail: deltest@bol.net.in
Nature of Lab: Open to others
Operations at: permanent facility
Central Quality Assurance Laboratory, Nastle India Limited, Moga
Address: Contact Details:
Post Box No. 11, Firozpur-Ludhiana Road, Tel No. 01636-236280, 290
Moga-142001, Punjab, India. Fax No. 01636-236279
Nature of Lab: In-house E-mail: vijendra_prakash.gupta@in.ne
Operations at: permanent facility
Central Laboratory, Bureau of Indian Standards, Sahibabad
Address: Contact Details:
Plot No. 20/9 Site-IV, Tel No. 0120-2770032, 2770821
Sahibabad Industrial Area, Fax No. 0120-2770219
Sahibabad-201010, Uttar Pradesh, India. E-mail: biscl@nda.vsnl.net.in
Nature of Lab: Open to others
Operations at: permanent facility
Spectro Analytical Labs (P) Ltd., New Delhi
Address: Contact Details:
C-55,Okhla Industrial Area Phase-I Tel No. 011-26817949/50/51
New Delhi-110020, India. Fax No. 011-26817954
Nature of Lab: Open to others E-mail: umesh@spectrolabindia.com
Operations at: permanent facility
Shriram Institute for Industrial Research, Delhi
Address: Contact Details:
19, University Road, Tel No. 011-27667267/27667860
Delhi-110007, India. Fax No. 011-27667676/27666013
Nature of Lab: Open to others E-mail: sridlhi@vsnl.com
Operations at: permanent facility
SGS India (P) Ltd, General Laboratory, Gurgaon
Address: Contact Details:
250, Udyog Vihar, Phase-IV, Tel No. 0124-2399990-98
Gurgaon, Haryana, India Fax No. 0124-2399765
Nature of Lab: Open to others E-mail: kurian_plus@sgs.com
Operations at: permanent facility

LEGAL STATUS OF AYURVEDIC, SIDDHA AND UNANI MEDICINES 121

Quality Control Laborator y for Processed Foods, Ludhiana
Address: Contact Details
Punjab Horticultural Post Harvest Tel No. 0161-2405257
Technology Centre, PAU Campus, Fax No. 0161-2405257
Ludhiana-141004, Punjab, India. E-mail: ptc@satyam.net.in
Nature of Lab: Open to others
Operations at: permanent facility
Food Research and Analysis Centre, New Delhi
Address: Contact Details
Plot 2A, Sector 8, Dwaraka, Tel No. 011-25360791-4
New Delhi-110045, India. Fax No. 011-25360802
Nature of Lab: Open to others E-mail: frac@del3.vsnl.net.in
Operations at: permanent facility
International Testing Centre, Panchkula
Address: Contact Details
86, Industrial Area, Phase-I Tel. No, 0172-2561543/2565825
Panchkula-134109, Haryana, India. Fax No. 0172-2561543
Nature of Lab: Open to others E-mail: kesho@mantraonline.com
Operations at: permanent facility
National Agriculture and Food Analysis and Research Institute, Pune
Address: Contact Details
3rd Floor, MCCIA Building, Tilak Road, Tel No. 020-24440079
Pune-411002, Maharashtra, India. Fax No. 020-24441776
Nature of Lab: Open to others E-mail: nafari@vsnl.net
Operations at: permanent facility
Reliable Analytical Laboratories
Address: Contact Details
A-I, 5 Acres, Kothari Compounds, Tel No. 022-25899490/25899491
Near Tikuji-ni-wadi, Manpada, Fax No. 022-25899492
Thane (W)-400605, Maharashtra, India. E-mail: reliablelabs@vsnl.net
Nature of Lab: Open to others
Operations at: permanent facility
Bureau of Indian Standards (WROL), Mumbai
Address: Contact Details
Manakalaya, E-9, MIDC, Tel No. 022-28327856/7891
Behind Marol Telephone Exchange, Fax No. 022-28262057
Andheri (E), Mumbai-400093, Maharashtra E-mail: wrol@bis.org.in
Nature of Lab: Open to others
Operations at: permanent facility
Ashco Analytical Services, Mumbai
Address: Contact Details
Lab House Plot No. F-13, Opp Seepz, Tel No. 022-28361002/28376701
MIDC, Andheri (E), Mumbai-400093 Fax No. 022-28350286
Nature of Lab: Open to others E-mail: mohite@ashcoindustries.com
Operations at: permanent facility

122 LEGAL STATUS OF AYURVEDIC, SIDDHA AND UNANI MEDICINES

SGS India Limited
Address: Contact Details
Behaia Industrial Complex, Phase-II, Tel No. 033-24463275
Ist Floor, 620, Diamond Harbour Road, Fax No. 033-24470267
Kolkota-700001, West Bengal, India. E-mail: nemai_ghosh@sgs.com
Nature of Lab: Open to others
Operations at: permanent facility
Choksi Laboratories Limited, Indore
Address: Contact Details
6/3, Manoramaganj, Indore-452001, M.P Tel No. 0731-2490592, 2493592-93
Nature of Lab: Open to others Fax No. 0731-2490593
Operations at: permanent facility E-mail: choksi@vsn.comcll@touchtell
Tea Research Institute (Upasi Tea Research Foundation)
Address: Contact Details
Plot No-2, S.P. Biotech Park, Tel No. 04253-255301/235303
Genome Valley, Hyderabad-500078, A.P. Fax No. 04253-235302
Nature of Lab: Open to others E-mail: upasi@vsnl.com
Operations at: permanent facility
Trace Analysis Lab of Vimta Specialities (P) Ltd., Hyderabad.
Address: Contact Details:
Plot No. 2, S.P. Biotech Park, Tel No. 040-27264400,093978786
Genome Valley, Hyderabad-500078, A.P. Fax No. 040-27263657
Nature of Lab: Open to others E-mail: vimtahq@vimta.com
Sipra Labs Private Ltd., Hyderabad
Address: Contact Details
4th Floor, Nilgiri, Adity Enclave, Amerpet, Tel No. 040-23776879/23734720
Hyderabad-500038, A.P., India. Fax No. 040- 23746871
Nature of Lab: Open to others E-mail: director@sipralabs.com
Operations at: permanent facility
Shiva Analytical (I) Ltd., Hoskote
Address: Contact Details:
Plot No. 24D (P) & 34 D, Tel No. 08079-71713/71322
KIADB Industrial Area, Fax No. 08079-71321
Bangalore Rural North, Hoskote-562114 E-mail: gupta@shivatecindia.com
Karnataka, India.
Nature of Lab: Open to others
Operations at: permanent facility
SGS India (P) Ltd, Cochin
Address: Contact Details
Aspinwall compound, Subramanian Rd. Tel No. 0484-2668913-14
Cochin-682003, Kerala, India. Fax No. 0484-2668912
Nature of Lab: Open to others E-mail: sunnykutty_abraham@sgs.com
Operations at: permanent facility

India. India. Vijaynagar. 044-22541087 Nature of Lab: Open to others E-mail: sro@bis. India.org Operations at: permanent facility Vimta Labs Ltd.com Operations at: permanent facility Laboratory Services Division. New Street. 011. E-mail: vimtalab@hd1vsnl.R). Fax No. Laboratory & Technical Division. E-mail: endesign@sancharnet. Tel No. New Delhi-110020.27263657 Andhra Pradesh. Fax No. New Delhi Address: Contact Details Sahid Capt.in Nature of Lab: Open to others Operations at: permanent facility . India. 011-26847973 Okhla. Fax No.in Operations at: permanent facility Bangalore Test House. Tel. Kottur. Kerala.net. LEGAL STATUS OF AYURVEDIC. 044-25541442 Chennai-600089.P. E-mail: rtcnr@nde. Tel No. Gaur Marg. Ramavaram Road. Tel No. 080-23385979 Nature of Lab: Open to others E-mail: testhouse@satyam. Ponnamma Chambers. Sargam Metals (P) Ltd.ingrove Nature of Lab: Open to others Operations at: permanent facility Regional Testing Centre (N.C. Manapakkam.II. 2761003 Kollam-691001. Cherlapally. 044-24470317 Nature of Lab: Open to others E-mail: mariappan_meena@sgs. Marenahalli. 044-24473929 Tamil Nadu. Kollam Address: Contact Details V-Floor. Okhla. Tamil Nadu. Tel No.net. 0474-2472704.net. . Fax No. SIDDHA AND UNANI MEDICINES 123 SGS India (P) Ltd.26847973/26312671 Opposite Modi Flour Mills. India. Bangalore Address: Contact Details 65. Kochi Address: Contact Details 44/150. Chennai-600085 Tel No. Karnataka. India. Hospital Rd Tel No. 0474-274704 Nature of Lab: Open to others E-mail: cepclab@cashewindia. Fax No. 080-23356415. 0484-2403154 Kochi-628018.E. Kerala. 040. Chennai Address: Contact Details 2. SRM Road Ernakulum. 2338988895 Bangalore-560046.in Operations at: permanent facility Chemieco Labs of Envirodesigns & Equipments. Chennai Address: Contact Details 21. Fax No. India. IDA Phase. No. 040-27264141 Hyderabad-500051. 20th Main.in Nature of Lab: Open to others Operations at: permanent facility C. Hyderabad Address: Contact Details 142.org.vsnl.

India. India. 0172-2236218 Nature of Lab: Open to others E-mail: nrol@bis. 044-2432374/2431157 Tamil Nadu. Fax No. E-mail: lab@sunbeamauto. 044-2433158 Nature of Lab: Open to others E-mail: nthsr@tn.com Operations at: permanent facility Geological & Metallurgical Labs Address: Contact Details 105x. Phase VII. 088-23472020/2347065 Yeswasnthpur Ind. SIDDHA AND UNANI MEDICINES Anulab Industrial Testing & Analytical Laboratories.com Operations at: permanent facility Bureau of Indian Standards (NRL).355664 U. Ballabgarh Address: Contact Details 21.net Nature of Lab: Open to others Operations at: permanent facility National Test House Address: Contact Details Taramani. Stone. 0124-26371010 Haryana. Agra Address: Contact Details 33. (Diagnostic Centre). II Stage. 0172-2236218/722 S. Fax No. Agra-282003. Gurgaon-122001 Fax No. Tel No. Nagar-160051..124 LEGAL STATUS OF AYURVEDIC. 0124-26372580/26372980 Narsingpur.com Nature of Lab: Open to others Operations at: permanent facility VXL Technologies Ltd. Distt. Faridabad-121006. Tel No. 0562-382093. Fax No.P. Tel No. 3rd Main. 3rd Cross. (Metallurgical lab) Address: Contact Details 20/3. India. Mohali Address: Contact Details: B-69. 0129-2241265 Nature of Lab: Open to others E-mail: starwire@giasdl01.net. India. No.in Operations at: permanent facility Sunbeam Auto Ltd. Industrial Focal Point Tel No. 0129-2305600/1/2 Haryana. K. Ropar (Punjab) Fax No. Fax No. Delhi-Jaipur Highway. (Testing R&D Centre) Address: Contact Details 38/6.vsnl. Goranguntepalya.nic. 0129-2305608 Nature of Lab: Open to others E-mail: vtl@vxltechno.in Operations at: permanent facility Star Wire (I) Ltd. Mathura Rd. Chennai-600058.org. Tel. Tel No.S. Fax No. Sub. 088-23471011 India. 0129-2241263/64 Haryana. Gandhi Nagar. Ballabgarh-121004.M. India. 0562-358826 Nature of Lab: Open to others E-mail: anulab@agraonline. Pin 560022 E-mail: gml980@vsnl. Mathura Rd.A. Tel No.in Operations at: permanent facility .

080-26521894 Basaranagadi. Chennai-682005 E-mail: ail@interfieldlaboratories. 040-230000361 Nature of Lab: Open to others E-mail: bnmurty@eptri. 0761-2330433/2331495 Jabalpur-482011. Vanagaram Rd.. Fax No. Madhya Pradesh. Ramavaram Rd. 033-25771353 Nature of Lab: Open to others E-mail: rtc-cal@wb. A. SIDDHA AND UNANI MEDICINES 125 Microlab. No. 044-26531514. Tel No. LEGAL STATUS OF AYURVEDIC. India. Kolkata-700108. Chennai Address: Contact Details 170/2. Gachi Bowli.cor Nature of Lab: Open to others Operations at: permanent facility .P. Nature of Lab: Open to others Operations at: permanent facility Interfield Laboratories. Kochi. Fax No. Chennai Address: Contact Details 2. B. Interprint House. Fax No. Tel No. India.com Operations at: permanent facility Regional Food Research & Analysis Centre Address: Contact Details 155/1.R). Bangalore-560004 E-mail: rfrac@vsnl. 0761-2330016-19 Indian Ordnance Factories. Tamil Nadu. 0484-2210915/2211838 First Floor. Sargam Metals (P) Ltd. Road. Tel No. Kolkata Address: Contact Details 111 & 112. Fax. Jyothi.com Nature of Lab: Open to others Operations at: permanent facility Regional Testing Centre (E.nic.co. Manapakkam. Serllingampally (M). Tel No. 044-22491117/6736 Chennai-600089. E-mail: lab@sargammetals.T. 033-25774055/0686 West Bengal. Nature of Lab: in-house Operations at: permanent facility Environment Protection Training & Research Institute (EPTRI Laboratory) Address: Contact Details 91/4. 044-26530589 Nature of Lab: Open to others E-mail: balajialloys@yahoo. Cochin Address: Contact Details XIII/1208-A. 26530205 Chennai-600058. Fax No.inmicro Operations at: permanent facility Laboratory Services Division. Athipet. India.in Operations at: permanent facility Gun Carriage Factory Address: Contact Details Metallurgical Laboratory. India. Tel No. 044-22491651 Tamil Nadu. India. 040-23000489/01241 Hyderabad-500032. Tel No.net. Subbarama Chetty Circle Tel No.

.P.. India. E-mail: namasivayam. 0172-2791144 Chandigarh-160019. Tel No. Estate. 0129-2242100/2246175 Nature of Lab: Open to others E-mail: nccbm@giasbi01.M. India.in Operations at: permanent facility IDMA Laboratories Ltd.net.28391593 Peenya. Synthite Indu. 022-55974999 Purushottam Kheraj Marg.co. Mumbai Address: Contact Details 36/37. Kerala. 0484-2761181-82 Kolenchery-682311.com Operations at: permanent facility Geo-Chem Laboratories (P) Ltd. Delhi-Mathura Road Tel No. Tel No. Fax No. Ltd. 080-28394354.com Nature of Lab: Open to others Operations at: permanent facility Quality Assurance Laboratory.net. 080-28394352 Karnakaka.Gautam Budh Nagar. Madhya Marg Tel No. Noida Address: Contact Details A-8A. Tel No. Mulund (W) Fax No. Fax No. Kadayiruppu.in Nature of Lab: Open to others Operations at: permanent facility National Thermal Power Corpn. 011-27392997 Nature of Lab: Open to others E-mail: info@avonagro. Sector 26. U. Bangalore Address: Contact Details st 3. Tel No. Ist Floor. Research & Development Centre.. 0120-259128. Panchkula Address: Contact Details SCO 12. Fax No. K. Peenya Industrial Area. Bangalore-560058. 0484-3051351 Nature of Lab: Partly open to others E-mail: synthite@synthite.in Operations at: permanent facility AVON Food Lab. E-mail: laboratory@gechemgroup. 02255974616 Mumbai-400080. Delhi Address: Contact Details C-35/23. Fax No. India. 1 Phase.Stone.vsnl. 0172-2793041 Nature of Lab: Open to others E-mail: idmalabs@satyam. 0129-2242051-56 (NH-2). Ballabgarh-121004. India. palani@itc. Haryana. Fax No.in Operations at: permanent facility . 0120-2410311 Nature of Lab: Open to others E-mail: goel@ntpcrd.ernet. SIDDHA AND UNANI MEDICINES ITC Group Research and Development Centre. Chemical Lte. India Fax No. Sec-24. India. Tel No.2410576 Noida-201301. Kolenchery Address: Contact Details Synthite valley.com Operations at: permanent facility National Council of Cement & Building Material Address: Contact Details 34. Lawrence Road Industrial Area. India.126 LEGAL STATUS OF AYURVEDIC. Raja Indu. Dist. 011-27391116 Delhi-110035.

com Nature of Lab: Open to others Operations at: permanent facility Eskaps (I) Private Ltd. India. Tel No. Indu. India. Jawaharlal Nehru Rd. Tel No. Ground Floor.in Nature of Lab: Open to others Operations at: permanent facility . Kirti Nagar. E-mail: aqcl@rediffmail. 080-23341230. 011-25463784 New Delhi-110015. Tel.com Nature of Lab: Open to others Operations at: permanent facility ARBRO Pharmaceuticals Ltd. Vishakapatnam-530001 2502089. Kolkata Address: Contact Details 38. Area Fax No. E-mail: arbor@vsnl. 011-25467228.. Sec-8. Fax No. New Delhi Address: Contact Details (Analytical Division) Tel No. SIDDHA AND UNANI MEDICINES 127 Essen and Company.Main Road. 033-22298957/9682 Kolkata-700016. E-mail: sgs_india@sgs. India. 18th Cross. Post Box 82. Kabir Road. Bangalore-560055 Fax No. Off. 040-23000344. 27 Andhra Pradesh. Fax No. Tel No. Address: Contact Details Plot No. India.in Operations at: permanent facility SGS India (P) Ltd. 080-23312659 Nature of Lab: Open to others E-mail: essenblr@vsnl. 02836-21857/30185 Near Osla Theatre. 033-24658305 West Bengal. Bangalore Address: Contact Details 106. 23000861 Hyderabad-500008. Tel No. 033-22495917 Nature of Lab: Open to others E-mail: eskaps@vsnl. 0891-2566964. Andhra Pradesh. 040-23000343 Nature of Lab: Open to others E-mail: hyd2_ncbhyd@sancharnet.com Operations at: permanent facility SGS India (P) Ltd.com Nature of Lab: Open to others Operations at: permanent facility Aglow Quality Control Laboratory (P) Ltd. Gandhidham Fax No. India. Kolkata Address: Contact Details 30. Kolkata-700026. LEGAL STATUS OF AYURVEDIC. 130.23341567 Malleswaram West. Old Bombay Road. Haroon Manzil. Tel No. 25457922 4/9. Gujarat. Visakhapatnam Address: Contact Details 24-01-30. 02836-232883/230645 Kutch-370201. National Council for Cement & Building Materials Address: Contact Details NCB Bhavan. Thompson Street. E-mail: rajesh_chanpura@sgs. West Bengal. India.net Operations at: permanent facility Independent Testing Lab. No.

0120-2534025. 011-26810444/2681555 New Delhi-110020 Fax No. 2543829 Jammu-180001 Fax No. 022-24937942. 0191-2543829. 0191-2573064. Lucknow-226015. E-mail: beepharma@vsnl. U. Okhla Industrial Area. (P) Ltd. SIDDHA AND UNANI MEDICINES ASHCO Analytical Services.O. 0522-2342666 Nature of Lab: Open to others E-mail: cimap@flashmail. New Delhi Address: Contact Details C-95. (CSIR). 0522-2717434 India. Phase-I. E-mail: aasnoida@rediffmail. Fax No. Jammu Address: Contact Details : Canal Road. Tel No.2533784 India. CIMAP. E-mail: agarwalsg@yahoo.com Nature of Lab: Open to others Operations at: permanent facility . Delhi (NCR)-201301 Tel No. E-mail: cmecc@vsnal.com Nature of Lab: Open to others Operations at: permanent facility Sophisticated Industrial Materials Analytical Labs. Tel No. Sec-2. 022-24932874 India. Tel No. Kakad Estate.com Operations at: permanent facility Regional Research Laboratory.com Nature of Lab: Open to others Operations at: permanent facility Central Institute of Medical & Aromatic Plants. 2548607 J & K.128 LEGAL STATUS OF AYURVEDIC. R.com Nature of Lab: Open to others Operations at: permanent facility Bee Pharmo Labs (P) Ltd. Fax No. Tel No. Mumbai-400018. 24963022 Worli. Noida Address: Contact Details D-70. Lucknow Address: Contact Details P. 011-26811777 India.P. Jammu Tawi. Maharashtra. Noida. Mumbai Address: Contact Details 5-6-7. Thadani Marg. India.G.

Govt. of India Department of AYUSH Ministry of Health and Family Welfare Pharmacopoeial Laboratory for Indian Medicines GHAZIABAD .