Drugs & Cosmetics

Act, 1940
DRUG

 A drug is any substance or product that is used or

intended to be used to modify or explore
physiological systems or pathological states for
the benefit of the recipient. – WHO

 It is defined as any substance used for the

purpose of diagnosis, prevention, relief or cure of
a disease or treatment in man or animals.
COSMETIC
Act

Rules
 History
1927 – Complaint regarding drug adulteration.

1930 – Forwarded to assembly, committee formed.

1937 – Report to form acts. Import of Drugs Bill

1940 – Act passed, Drugs act.

1945 – Drug rules.

1962 – Addition of cosmetics, D & C Act.

1964 – Addition of ISM (Indian system of medicine).

 Need of standardization
Globalization of Ayurveda.

65% population uses traditional medicines.

25% population uses traditional remedies.

Imbalance between demand & supply.

Adulteration or poor quality drug came into exist.

Issues regarding safety of ayurvedic medicine.

Need of standards for quality drug.

STANDARD

 The standard is numerical value which quantify

the parameter and thus denotes quality and
purity of a material.

Drug standardization is the method to evaluate a

drug for its purity, quality, safety and efficacy.
WHEN SCIENCE BECOMES INDUSTRY…..

 Indian market - estimated as Rs. 440 cr.

 Global market - Rs. 4205 cr.

 By 2020 – estimated as Rs. 7000 cr.

 Demand
Vs
Supply

65% population uses

Traditional Medicines

25% population uses

Traditional Remedies
 Mercury
BAN

Herbal Drugs
BAN
 RAJ-AASHRAY – IGNORANCE TOWARDS
AYURVEDA

 Govt. is not promoting Ayurved?????.

 Question on opportunities for ayurvedic graduates.

 Even Ayurvedic persons do not have faith in their science.

 (MIS)BELIEFS ABOUT AYURVEDIC DRUGS

 No effect, No side-effect.

 100% safe ***

 Acting slowly

 Have limitations***
 Anatomy

D & C Act D & C Rules

• 5 chapters • 19 parts
• 38 sections • 170 rules
• 2 schedules • A – Z schedules
•CHAPTER I (sections 1-4, including 3A thus 5 in number)– INTRODUCTORY

•CHAPTER II (sections 5-7A, 4 in number)- THE DRUGS TECHNICAL ADVISORY BOARD, THE
CENTRAL DRUGS LABORTORY AND THE DRUGS CONSULTATIVE COMMITTEE

•CHAPTER III (sections 8-15, including 9 A-B-C-D & 10A, thus 13 in number)- IMPORT OF
DRUGS AND COSMETICS

•CHAPTER IV (sections 16-33A, including 17 A-B-C-D, 18 A-B, 26A, 27A, 28 A-B, 31A, 32A,
33A thus 31 in number)- MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND
COSMETICS

•CHAPTER IVA (sections 33B-33O, 19 in number)- PROVISIONS RELATING TO AYURVEDIC

SIDDHA AND UNANI DRUGS

•CHAPTER V (sections 33P-38, - including 34A-AA, 36A, thus 9 in number)- MISCELLANEOUS

 Our concern
 Act

Chapter 4 A
Sections (acts) 33 B – O
Schedule 1 – Books (54 of Ayu. addition of API,
AFI,
Ayu. sara samgraha)
Schedule 2 - Standards to be complied with different class of drugs.
33B. Application of Chapter IVA.

33C. Ayurvedic, Siddha and Unani Drugs Technical Advisory Board.

33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee.

33E. Misbranded drugs.

33EE. Adulterated drugs.

33EEA. Spurious drugs.

33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs.

33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drugs.

33EED. Power of Central Government to prohibit manufacture etc., of Ayurvedic, Siddha or Unani drugs in public interest.

33F. Government Analysts.

33G. Inspectors .

33H. Application of provisions of sections 22, 23, 24 and 25.

33I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drugs in contravention of this Chapter.

33J. Penalty for subsequent offences.

33K. Confiscation .

33L. Application of provisions to Government departments.

33M. Cognizance of offences.

33N. Power of Central Government to make rules.

33O. Power to amend First Schedule.

Rules
Parts 16 – 19, Rules 151 – 170

Schedule Subject

A Forms

E1 Toxic drugs

S Standards for cosmetics

T GMP

V Standards for patent or proprietary medicines

Y Requirements and guidelines for permission to import and

/ or manufacture of new drugs for sale or to undertake
clinical trials
 Cont…..
Appendix I - Data required to be submitted with application for
permission to market a New Drug.

Appendix II - Format for submission of clinical Trial Reports.

Appendix V - Patient consent form for participation in a

Phase I Clinical Trial.

Appendix IX – Stability study.

Appendix XI – ADR.
Act 33 E – Misbranded drugs

If colored, coated, powdered or polished to

conceal the damage or
made to appear of better or greater
therapeutic value than it really is

If it is not labeled in the prescribed manner

If its label or container bears any statement,

design or device which makes false or
misleading claim for the drug
Act 33 EE – Adulterated drugs

If it consists of any filthy, putrid or

decomposed substance

If it has been prepared, packed or stored

under insanitary conditions

If its container is composed of any poisonous

or deleterious substance which may injurious
to health
Cont…..

If it contains, for purposes of coloring only, a

color other than prescribed

If it contains any harmful or toxic substance

which may injurious to health

If any substance has been mixed therewith to

reduce its quality or strength.
Act 33 EEA – Spurious drugs

If it is imported under a name which belongs

to another drug.

If it is an imitation of or resembles another

drug in a manner to deceive or
bears upon it or upon its label or container the
name of another drug.

If the label or the container bears the name of

an individual or company which is fictitious
or does not exist
Cont…..

If it has been substituted wholly or in part

by another drug or substance

If it has been shown to be the product of a

manufacturer of whom it is not truly a
product.
Rule 161 – Labeling, Packing and Limit of Alcohol in
Ayurvedic (including Siddha) or Unani Drugs
 Name of the drug (classical),
 Ingredients with quantity*,
 Reference with Adhikaran,
 If it contains drugs under Schedule E (1), Caution: To be taken under medical
supervision,
 Name and address of the manufacturer,
 Manufacturing License Number,
 Batch number or Lot number,
 The date of manufacture - completion of the final product or the date packing,
 The words “Ayurvedic medicine” ,
 The words “FOR EXTERNAL USE ONLY” if in case,
 Physicians sample. Not to be sold.

Expiry date, Dose ???????

 Cont…
Preparations with high content of alcohol as base

Name of the drug Maximum size of packing

Karpur Asava 15 ml
Ahiphenasava 15 ml
Mrgamadasava 15 ml

Preparations containing self-generated alcohol

Name of the drug Maximum content of Maximum size
Alcohol (ethyl alcohol of packing
v/v)
Mritsanjivani Sura 16 % 30 ml
Mahadrakshasava 16 % 120 ml
Rule 161 A– Exemption in labeling and packing provisions
for export

 Name of the Ayurvedic, Siddha and Unani drug - Single or

compound formulations,

 Name, address of the manufacturer and the number of license

under which the drug has been manufactured,

 Batch or lot number,

 Date of manufacture, along with the date for “Best for use
before”,

 Main ingredients, if required by the import country.

Rule 161 B– Shelf-life of ASU drugs

Shelf life Formulations

Infinite Kupipakva Rasayana, Parpati, Pishti, Asava-Arishta, Bhasma of

swarna-rajata-lauha-mandura-abhraka-godanti-shankha.

One year Arka, netra-bindu.

Two years Ghrita, Churna, Kwatha Churna, Manjana, Varti, Shweta

Parpati, Karna-bindu, Nasa-bindu, Dhoopana Dravya, Paste.

Three years Taila, Avaleha, Gutika Of Kashthaushadhi, Ghana Vati, Lepa

Churna, Malahara, Lepa Guti, Pravahi Kwatha, Soft Gelatin
Capsules, Liquid Orals.

Five years Gutika Of Rasaushadhi, Guggulu, Dravaka, Lavana, Kshara,

Bhasma Of Naaga – Vanga – Taamra, Hard Gelatin Capsules.

Ten years Lauha and Mandura kalpa.

Rule 168– Standards of ASU drugs (applicable from 26th June 1995)

Class of Drugs Standards to be complied with

Single drugs included The standards for identity, purity and

in Ayurvedic Strength as mentioned in Ayurvedic
Pharmacopoeia. Pharmacopoeia of India (API).

Asavas and Arishtas The upper limit of alcohol as self

generated alcohol should not exceed
12% v/v.

Rule 169– Permitted additives etc.

Rule 170 - Guidelines for clinical evaluation of ASU drugs.

 D & C Rules, Schedule E1
1) Toxic Drugs of vegetable origin
Sanskrit name Latin name
Ahipena Papaver somniferum Linn.
Arka Calotropis gigantea Linn.
Bhallataka Semicarpus anacardium Linn.
Bhanga Cannabis sativa Linn.
Danti Baliospermum monatanum Mull. Arg
Dhattura Datura metal Linn.
Gunja Abrus precatorius Linn.
Jaipala Croton tiglium Linn.
Karaveera Nerium indicum Mill.
Langali Gloriosa superba Linn.
Parasika Yavani Hyoscyamus nigar Linn.
Snuhi Euphorbia neriifolia Linn
Vatsanabha Acontium Chasmanthum Stapfex Holm.
Shringivisha Acontium Chasmanthum Stapfex Holm.
Vishamushti Strychnox nuxvomica Linn.
 Cont…
2) Toxin of animal origin – Sarpa Visha

3) Toxic Drugs of Mineral origin

Sanskrit name Latin name
Gauripashana Arsenic
Hartala Arseno sulphide
Manahashila Arseno sulphide
Paarada Mercury
Rasa Karpura Hydrargyri subchloridum
Tuttha Copper sulphate
Hingula Cinnabar
Sindura Red oxide of lead
Girisindura Red oxide of mercury
Note:
Seeds of Ahiphena & Bhanga are not considered as poisonous.

Only the seeds of Gunja & Jaypala are considered as poisonous.

Vatsanabha & Shrungivisha both are grouped under one.

Snuhi is omitted from the list.

Sindura & Girisindura are omitted from the list.

Category Previous Present

Herbal 15 13
Animal 1 1
Mineral 9 7
Total 25 21
 Schedule T
GMP for ASU medicines - enforced : 23rd June, 2000.
Aims & Objectives :

≠ Raw materials used are authentic, of prescribed quality and are free
from contamination,

≠ The manufacturing process is as prescribed to maintain the

standards,

≠ Adequate quality control measures are adopted,

≠ The manufactured drug which is released for sale is of acceptable

quality.
Part 1 : Good Manufacturing Practices.

Part 2 : List Of Machinery, Equipment and Minimum Manufacturing

Premises required for the manufacture of various categories of
medicines & list of equipment recommended for in house Quality-
Control section.

 Under IMCC Act 1970 registered Vaidyas, Siddhas and Hakeems who
prepare medicines on their own to dispense to their patients and not
selling such drugs in the market are exempted from the purview of Good
Manufacturing Practices (GMP).
 GMP – Good Manufacturing Practices
Premises

Location and surroundings - Such as to avoid contamination from Open Sewerage,

Drain, Public Lavatory, any factory which produces Disagreeable/ Obnoxious Odor,
Fumes, Excessive Soot, Dust and Smoke.

Buildings –
 Such as to permit production of drugs under hygienic conditions.
 Should be free from cobwebs and insects/rodents.
 The floor and the walls should not be damp or moist.
 Interior surface shall be smooth and permit easy cleaning and disinfection.
 It should have adequate provision of light and ventilation,
 Fire safety measures and proper exits.
 Proper and safe sanitary fittings & electrical fixtures in the manufacturing area.
 Provided with proper drainage system in the processing area.
Area – The manufacturing plant should have adequate space for –
 Receiving and Storing raw material;
 Manufacturing process areas;
 Quality control section;
 Finished goods store;
 Office;
 Rejected goods/drugs store.

• Storage should have proper ventilation and shall be free from dampness.

• Adequate space for storage of different types of materials

i.e. Raw material, Packaging material and Finished products.

• Clean, dry and maintained within acceptable temperature

limits. Where special storage conditions are required (e.g. temperature,
humidity) these shall be provided, controlled, monitored and recorded
where appropriate.
• Rest and refreshment rooms, separate from manufacturing and control areas.

• Maintenance workshops should separated from production areas. Whenever

parts and tools are stored in the production area, they should be kept in
rooms or lockers reserved for that use.

• Animal houses should be well isolated from other areas, with separate
entrance (animal access) and air-handling facilities.

• Drains should be of adequate size and designed and equipped to prevent

back-flow.

• Open channels should be avoided where possible, but if they are necessary
they shall be shallow to facilitate cleaning and disinfection.
Production area

 To allow orderly and logical placement of equipment and materials.

 To control the possibility of cross contamination by other drugs.

 Separate space for drying of materials of various stages i.e. raw material,
in process etc.

 Must be protected from flies/ insects/ dust etc. by proper flooring, wire
mesh window, glass panels or other material.

 Furnace/Bhatti section could be covered with tin roof and proper

ventilation, but sufficient care should be taken to prevent flies and dust.

Water supply - Pure and potable water. Adequate provision of water for
washing.
Hygiene - Most important because use of herbal origin raw material in
manufacturing and maximum chances of microbial contamination is there.

 Personal hygiene for workers and other staff – should be free from
infectious disease and skin disorders.

 Direct contact shall be avoided between the operator’s hands and starting
materials, primary packaging materials and intermediate or bulk product.

 Waste disposal

 Validated methods for cleaning equipments & premises – vacuum / wet

cleaning. Cleaning by brushes & compressed air should be avoided.

 Health clothing (according to nature of work), mask / gloves when

necessary.

 Sanitation – separate provision and away from production area.

Medical services – Facilities of first-aid. Periodical medical examination.

Materials – Raw materials must be of expected quality.

 Proper storage with labeling includes

 Name of the raw material,
 Source of supply
 Status of material - ‘UNDER TEST’ or ‘APPROVED’ or ‘REJECTED’.
 Batch No. or Lot No.
 Date of receipt of the consignment.

 Stored in appropriate containers which would prevent it from damage due

to dampness, microbiological contamination etc.

 Separate cabins and compartments for different degree of materials i.e.

 Metallic Origin.
 Mineral Origin
 Animal Origin
 Fresh Herbs
 Dry Herbs Or Plant Parts
 Excipients etc.
 Volatile Oils/Perfumes And Flavors
Plant Concentrates/ Extracts And Exudates/Resins.
 Only permitted substances must be used for fumigation, preservation etc.

 Excepients etc should be comply with national / international regulations.

 All the raw materials shall be sampled and got tested either by the in-
house Quality control technical person or by the Government approved
laboratories .

 The rejected raw material should be removed from other raw material
store and should be kept in separate room.

 Packing Materials such as bottles, jars, capsules etc. shall be stored

properly and adequately cleaned and dried before packing the products.

 No materials used for operations such as cleaning, lubrication of

equipment and pest control, should come into direct contact with the
starting material, packing material, work in process or finished product.

 Toxic substances and flammable materials shall be stored in suitably

designed, separate, enclosures, as required by national legislation.
Equipments –

 Suitable equipment depending on the size of operation and the nature of

product .

 Either manually operated , semi-automatically, fully automatic machinery.

 If possible, equipment should be of non-wooden material and if

unavoidable, they should be used by taking specific measures as
wooden materials may retain odor, be easily discolored and are easily
contaminated.

 The parts of the production equipment that come into contact with the
product shall not be reactive, additive, or absorptive to an extent that would
affect the quality of the product.

 Regular and proper cleaning.

 Proper calibration.

 SOP for laboratory instruments.

Process validation –

Pre-process

In-process

Post-process

Personnel– Qualified staff for each division of pharmacy e.g. QC

Laboratory, production unit etc.

Rules of batch rejection – Labeled and stored separately. If reprocessed,

new batch number should be given and again tested for quality under
supervision of authorized personnel.
Quality Control – Quality control section will have a minimum of:

(i) One person with Ayurveda /Siddha/ Unani qualification recognized under
Schedule II of Indian Medicine Central Council Act, 1970 (84 of 1970).

(ii) Two other persons one each with Bachelor qualification in Botany/
Chemistry/ Pharmacy could be on part time or contractual basis.

• 150 sq. feet area for quality control section.

• Reference books and samples for identification of raw drugs.
• Manufacturing records for various processes.
• Controlled samples of finished products of each batch kept for 3 years.
• Keep record in establishing shelf life and storage requirements for the drugs.
Function of QC lab –

• To verify all the raw materials, monitor in process, quality checks and
control the quality of finished product.

• The standards for identity, purity and strength must be as given in

pharmacopoeia. Where tests are not available, the test should be
performed according to the manufacturers specification or other
information available.

• Manufacturers who are manufacturing patent / proprietary medicines shall

provide their own specification and control reference in respect of such
formulated drugs.

Limit of Heavy Metals for exports effective from 14th October, 2006

• Lead –10.0 ppm

• Arsenic –3.0 ppm
• Cadmium –0.3 ppm
• Mercury –1.0 ppm
Self inspection –

Complaints –

Product recalls –
Records – Each and every step of production, starting from raw
material to dispatched final product.

Raw material - Records of the receipt, storage, testing, approval/rejection

and use of raw material shall be maintained

Receipt – Date, Source, Form, Quantity, Cost etc.

Storage – Conditions, Container etc.
Testing - Date, Source, Parameters, Results, Approval/Rejection etc.
Usage - Date, Quantity, Primary Processing, Form etc.

Process - Reference, date, batch size, Materials, Principle, Procedure,

Equipments and their Specifications, Man power, Fuel/Electricity
Used, Precautions, Duration, Observations, CDC, Yield, % and
reason for Gain/Loss, Primary Analysis.

The record of specific method and procedure of preparations i.e. “Bhavana”,

“Mardana” and “Puta”.
Quality Control – Name of Product, Date, Parameters, Reference, Principle,
Procedure, Equipments and their Specifications,
Observations, Results, Approval/Rejection.

Packaging and Labeling – Packing & Labeling material, Quantity, Error if

any, transfer to finished good store.

Records of rejected batches, self inspection etc.

Final product – Name, Reference, Quantity, Ingredients with Ratio, Batch

Number, Date of Manufacturing, Quality Parameters.
Records of Dispatching,
Sale & Distribution - Duration is till expiry date,
for products having infinite shelf life – five years.
Market Complaints – Reason, Corrective Measures, Report at six month
interval.
ADR - Due to any defect in the product or such reactions are already reported
in the literature or it is a new observation.
Product Recalls etc.
 Schedule Y
Requirements and guidelines for permission to import and / or
manufacture of new drugs for sale or to undertake clinical trials

Application for permission should consist below information –

1) Chemical and pharmaceutical information.

2) Animal pharmacology data

 Specific pharmacological actions such as therapeutic potential for
humans, dose-response relationships and ED 50s.
 Special studies conducted to evaluate mode of action.
 General pharmacological actions
 Pharmacokinetic data related to the ADME.
If possible, correlate to plasma drug concentrations;
3) Animal toxicology data

4) Human Clinical Pharmacology Data – According to phases

5) Regulatory status in other countries in respect of restrictions, dosage limits,

exclusion of certain age groups, warning about adverse drug reactions,
withdrawal along with the reasons and their relevance, if any, to India.

6) Complete testing protocols for quality control testing.

For drugs indicated in life threatening / serious diseases or diseases of special

relevance to the Indian health scenario, the toxicological and clinical data
requirements may be deferred or omitted, as deemed appropriate by the
Licensing Authority.
The full prescribing information including -
 Generic name;
 Composition;
 Dosage form,
 Indications;
 Dose and method of administration;
 Use in special populations (such as pregnant, lactating women etc.) ;
 Contra-indications;
 Warnings;
 Precautions;
 Drug interactions;
 Undesirable effects;
 Overdose;
 Pharmaco-dynamic and pharmacokinetic properties;
 Incompatibilities;
 Shelf-life;
 Packaging information;
 Storage and handling instructions.
Responsibilities of -
 Licensing Authority – Permission
 Institutional Ethics Committee – Approval and review
 Trial Investigator – Conduct
 Sponsor –Scrutiny
GCP, SOP, ADR, Protocol, Service to individual

Approval at various stage i.e. IEC, licensing authority etc.

 Informed Consent
 Site
 Protocol amendments

Good Laboratory Practices compliance Laboratories.

 Phase Aim

I - Human • Maximum tolerated dose

Pharmacology • Expected adverse reactions
in healthy volunteers/ • Pharmacokinetics: ADME
certain types of patients • Pharmaco-dynamics
• Early measurement of drug activity.

II - Therapeutic • Particular indication

exploratory trials • Common short-term side-effects
• To determine the dose and regimen for Phase III trials.

III - Therapeutic • Demonstration or confirmation of therapeutic benefits.

confirmatory trials • Dose-response relationships
• Safety and efficacy in combination with other drugs .

IV - Post Marketing • Drug-drug interaction

Trials • Mortality/morbidity studies,
• Epidemiological studies etc.
Studies in special populations –
Geriatrics – Phase 3, disease of ageing, number of patients, safety.
Pediatrics – Safety study in adults, prior to older children.
Pregnant /nursing women – Excretion of drug, metabolites into milk

Post Marketing Surveillance –

PSUR – Periodic Safety Update Reports – at six month for 2 years.

Special studies:
Bioavailability / Bioequivalence Studies
Ayurvedic Pharmacopoeia Committee – APC - Sept. 1962
 To prepare an official formulary in two parts :-
1) Single drugs - Identity and therapeutic value.
2) Compound preparations - used in Ayurvedic practice throughout country.

 To provide standards for drug and medicines, commonly used in practice.

 To lay down tests for identity, quality and purity.

 To ensure uniformity, physical properties and active constituents as far as

possible.

 To provide information regarding the Particular characteristics,

Methods of preparation,
Dosage,
Method of administration
Vehicles
Toxicity.
 Publications for standards
Pharmaceutical standards for Ayurvedic formulations – 431 formulations

PLIM at Ghaziabad - 1970

API (2 parts)
• 1st – 10 volumes, 666 single drugs,
• 2nd – 4 volumes, 203 formulations.

AFI (3 parts)
• 1st – 444 formulations,
• 2nd – 191 formulations,
• 3rd – 351 formulations.
 API Part 1
Volume 1-5 : Monograph of single drugs

 Botanical description,
 Synonyms,
 Macroscopic / Microscopic characters,
 Standards for identity, purity & strength;
 Chemical constituents,
 Formulations,
 Therapeutic uses,
 Dose.

Volume 6 : Standards for rarely used drugs including TLC profile.

Standards for Jala, Sharkara, Guda, Ghee, Madhu, Tila Taila, Sarshap Taila,
Clove Oil, Camphor, Menthol, Eucalyptus Oil, Thymol.

Volume 7 : Minerals

Volume 8 – Monograph of a drug including standards of

Raw material, Powder, Hydro-alcoholic extract, Aqueous extract.
 Appendix Subject

Appendix 1 Apparatus for tests & assays.

Appendix 2 2.1 - Testing of drugs i.e. leaves, flowers, fruits, seeds, barks, roots, rhizomes.
2.2 – Quantitative data of vegetable drugs – Determination Of Foreign Matter,
Total Ash, Acid Insoluble Ash, Water/Alcohol Soluble Extractives, LOD,
Volatile Oil, Alkaloid Assay, TLC, Starch Content, Sugar Content, Fatty Oil
Estimation, Foaming Index, Protein Estimation.
2.3 – Limit tests for Arsenic, Lead, Iron, Heavy Metals, Chlorides, Sulphate etc.

Appendix 3 Physical tests & determination. Powder Fineness, Refractive Index, Specific
Gravity etc.

Appendix 4 Reagents & solutions.

Appendix 5 General information. Paribhasha, Shodhana process etc.

Appendix 6 Weights & Measures. Comparison with Maana-paribhasha.

 API Part 2

Volume 1: Monographs according to dosage forms i.e.

Avaleha, Churna, Ghrita, Guggulu, Vati-gutika, Kshara, Taila, Lepa.
 Definition,
 Composition with Latin name, part used and ratio,
 Method of preparation,
 Organo-leptic characters,
 Microscopy,
 TLC assay,
 Physico-chemical parameters,
 Storage,
 Therapeutic uses,
 Dose
 Anupana.
 Caution if any
Appendix 1-4 : same as of part 1

Appendix Subject

Appendix 5 Chemical tests & Assays.

Appendix 6 Ayurvedic definitions & methods. Paribhasha, Shodhana process etc.

Appendix 7 Weights & Measures. Comparison with Maana-paribhasha.

Appendix 8 Classical Ayurvedic references.

Appendix 9 List of single drugs of plant origin used in formulations, with

Latin nomenclature

Appendix 10 Bibliography
 Volume 2 : Monographs according to dosage forms i.e.
Asava-Arishta, Avaleha, Churna, Ghrita, Guggulu, Taila, Kshara-sutra.

Appendix 1-6 : Same as of volume 1

Appendix Subject

Appendix 7 Kshara-sutra.

Appendix 8 Weights & Measures. Comparison with Maana-paribhasha.

Appendix 9 Classical Ayurvedic references.

Appendix 10 List of single drugs used in formulations.

Appendix 11 Bibliography
 AFI Part 1
Part A: Monographs according to dosage forms including common
Definition, Method of preparation, Characteristic i.e.
Asava-arishta, Arka, Avaleha, Kvatha Churna, Ghrita, Guggulu, Churna, Taila,
Dravaka, Lavana-kshara, Lepa, Vati-gutika, Varti-Netrabindu-anjana, Satva,
Kupipakva, Parpati, Pisti, Bhasma, Mandura, Rasayoga, Lauha.

 Shloka with reference,

 composition with part used & ratio,
 Dose,
 Important therapeutic use.
Note : Ayaskruti is mentioned under Asava-arishta.

Part B: Appendices – Paribhasha,

Shodhana,
Therapeutic Indices : formula wise & disease wise.
 AFI Part 2
Same as part 1 except Dravaka, Lavana-kshara, Satva, Kupipakva.

Other : AFI Common

 Formulary of single drugs – Animal origin : 114

Mineral origin : 179
Plant origin : 1048

 Common Appendices

• List of diseases / technical terms and their Approximate English equivalents

• Metric equivalents of classical weights and Measures