PAKISTAN- AN INTRODUCTION Pakistan is strategically located in South Asia connected to Central Asian republics through Afghanistan, China via

Korakoram highway and South East Asian countries through sea. It is spread over a landmass of 796,095 square kilometers. It is a land of opportunities for investment due to well-developed infrastructure, skilled manpower and open Government policy. 1. PHARMACEUTICAL SECTOR IN PAKISTAN

Pakistan meets 80% of its domestic demand of medicines from local production and 20% through imports. The pharmaceuticals market size is Rs. 70 Billion (US $ 1.2 Billion), approximately. The market for pharmaceuticals in Pakistan has been expanding at a rate of around 10 to15% since last few years. Pakistan is also exporting its surplus drugs to a large number of countries particularly to the Asian and African regions with an expanding trade in the newly emerged Central Asian States. About a hundred million strong population of the Central Asian States, with almost no local manufacture of medicines, offers an attractive market for industries located in Pakistan. Pakistan's large population of more than 140 million people, expanding economy including health services, individual rise in purchasing power, general awareness regarding use of new molecules of drugs, etc. provides an ideal environment for investment in this field. Presently the pharmaceutical industry in Pakistan is producing all the major pharmaceutical dosage forms. Similarly, there are some special products e.g. immunologicals, anti-cancer drugs, certain anti-diabetics, antidotes and products manufactured from biotechnology, which are still being imported, in the finished form. These specific areas provide excellent opportunities for investment. Only few bulk pharmaceutical raw materials are being manufactured locally and most of the pharmaceutical raw materials are being imported in large quantities from different countries of the world. This sector also gives challenge to explore and avail the opportunities. The Drugs Act, 1976, regulates the pharmaceutical sector in Pakistan. 2. · THE DRUGS ACT 1976 (SALIENT FEATURES) An Act to regulate the import, export, manufacture, storage, distribution and sale of drugs. It extends to the whole of Pakistan and Federally Administered Tribal Areas (including Export Processing Zones).

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1976. 1976. 1978. 1978. adhesive plasters. 1976 is a Federal legislation with distribution of functions between the Federal Government and Provincial Governments as follows:Federal Government Manufacture Registrations Pricing Import Export Provincial Government Sale Ø For the purpose of this Act a drug is defined in section 3 (g) and includes allopathic drugs. bandages. surgical ligature. The Drugs (Labelling and Packing) Rules. 1986. promotion to the professionals and advertisement of drugs to the general public. .Provide procedures to import the finished drugs and the raw materials. procedures and conditions for grant of Drug Manufacturing Licenses. Under this Act. disinfectants. . . The Drugs (Import and Export) Rules.Every lincesee is required to pay 1% of his gross profit towards a Central Research Fund. etc. sutures. Registering and Advertising) Rules 1976. registration of drugs. the Federal Government has laid down the following rules to carry out various functions entrusted to it under this Act:Ø The Drugs (Licensing. Federal Drug Laboratory and Federal Government Analysts) Rules. as the case may be. The Drugs (Appellate Board) Rules 1976. Drugs Act.Ø The State of Azad Jammu and Kashmir has also adopted this Act and the jurisdiction of the Central Licensing and Registration Boards constituted under this Act is extended to the territory of A J & K.Provide order of specifications which shall be applied to a registered drug. .Specify duties of Federal Drug Inspectors and the procedures of the Government Analyst. . dcomoh. The Drugs (Specifications) Rules.Provide the rules.gov. The Drugs (Federal Inspectors. pk> Ø Ø Ø Ø Ø Ø 2 . absorbent cotton. The Drugs (Research) Rules. Detailed information may be had from the following website:<http:// www. . administered by the Federal Government. .Provide procedures for making appeals before the Appellate Board against the decisions of the Central Licensing and Registration Boards.Prescribe the manners in which a registered drug shall be labeled. The pharmaceutical raw materials can be imported by the holders of valid Drug Manufacturing Licenses and the registration of the respective drug.

The Drugs Control Organization also has its field offices in the Provincial Headquarters.3. including Good Manufacturing Practices. The Provincial Governments have their own Inspectorates for post-marketing surveillance.pk> 3 . 1976 and rules made there under. Drugs Controller is the technical head of this Organization and the Director General is the departmental head. MANUFACTURING OF DRUGS Under the Drugs Act. 4. DRUGS CONTROL ORGANIZATION The Drugs Control Organization is a wing in the Ministry of Health.gov. 1976 four types of Drugs Manufacturing Licenses are issued depending upon the nature of activity of pharmaceutical manufacture as under: a) b) c) d) Formulation Basic Manufacture Semi Basic Manufacture Repacking As such a pharmaceutical unit (facility) can possess more than one license depending upon the nature of activities being undertaken. The Provincial Quality Control Boards have jurisdictions in Quality Control cases in the respective provinces. The number of pharmaceutical units set up in different provinces of Pakistan are as under:- A list of licensed manufacturers is available at the website <http://www. All the imports of pharmaceuticals are conducted through these offices. They also monitor the compliance to conditions of Drug Manufacturing Licenses.dcomoh. It executes its work under the Drugs Act.

The guidelines to this affect are given in Schedule B-1. Approval of the layout plan. it takes about 3-4 weeks for its approval. public lavatory or any factory. transfer of dividends and profits and appointment of foreign staff. Deed / lease document of the land / plot. the following documents are requested: a. if they comply with the requirements for grant of a license. Information about the company/firm. 4. 1976 with a view to ensuring production of drugs of standard quality. as provided in the rules. b. A panel of experts of the Central Licensing Board inspects the facilities to evaluate. which produces a disagreeable. for its proper identification. its directors or partners. The applicant is required to furnish a layout plan giving details of the flow of operations. Once the requisite information is complete. and makes a report to the Board. 2. A copy of the National Identity Card of the applicant. Now the only requirement is to obtain a Drug Manufacturing License under the Drugs Act. The proposed site should not be located in a place adjacent to an open sewerage. Once the conditions laid under the rules have been met. 5. by complying with notified current Good Manufacturing Practices. Verification of the site. the representatives of the Federal and Provincial Governments and the experts in medical and pharmaceutical fields. As soon as the facilities are complete a formal application for grant of a Drug Manufacturing License is made on a prescribed Form-I. Once the layout plan is found in order. d. A Central Licensing Board. dust or smoke. by way of formulation a minimum plot size of not less than 2000 square yards is required. which were previously required have been dispensed with. for a license by way of formulation is as under:1. or obnoxious odor or fumes or large quantities of soot. There is no government requirement for joint venture projects. a Drug Manufacturing License is granted without delay. For a license. . When a proposal is made for establishment of the a pharmaceutical unit.To establish a pharmaceutical unit in Pakistan all permissions relating to investment. c. for evaluation of the production and quality control facilities. 4 3. drain. alongwith the requisite fee. comprising 21 members including. Sketch of the proposed site. grants the Drug Manufacturing License The out line of the procedure. and drawn in line with the current Good Manufacturing Practices. the site verification takes about 3-4 weeks.

17.000/Rs.20. THE DRUG MANUFACTURING LICENSE FEE SCHEDULE 'F' Ø Ø Ø Site verification Approval of the layout plan Revision/expansion of lay out plan Rs.000/Rs.10.10. 7. it is ascertained that the manufacturer possesses matching facilities. The Board.500/Rs. Ø Ø Ø Ø 5. A license is issued for a period of five years at a time.000/Rs. with some variations of conditions depending upon the type of the license.6. 5 . The Board also takes into consideration the public interest.If the application for renewal is made before the expiry of the period of validity of license.35. 8. set up by the Federal Government under the Drugs Act. passes its orders on the report and recommendations of the panel of inspectors. efficacy.5.10.000/- Renewal of License . before registering a drug. Once an application for renewal has been made in time.5.000/Rs. 1000/ per section Rs. after which it is renewable on an application. quality and economy. in respect of registration of a drug for local manufacture. The procedural requirements for other types of Drug Manufacturing Licenses are similar as that of the Formulation. This Board. Basic Semi basic Formulation Repacking Rs. 500/ per section Grant of License Ø Ø Ø Ø Basic Semi basic Formulation Repacking Rs. A license may be suspended or cancelled or renewal denied if the licensee fails to comply with the conditions of license. which comprises 21 experts in the field. satisfies itself of its safety. 1000/Rs.000/- REGISTRATION OF DRUGS Registration of a drug is granted by the Registration Board.000/Rs. In addition. the license continues to be in force till the decision on the application. which meets every 6-8 weeks. 1976.

2) 3) 4) 5) 6) The Federal Government has set up Expert Committees including a committee on Biologicals and a committee on Veterinary Drugs for furnishing opinion after drug's evaluation. For every potency/strength of a drug a separate application is required. An application for registration of a drug to be imported is made in a prescribed Form-5 (A) under the said rules.000/Rs. 8. A registration is issued for a period of five years at a time. THE REGISTRATION FEE SCHEDULE IS AS UNDER:For grant of Registration Type of Drug New Drug Molecule Any other drug for import Any other drug for local manufacture including Glenicals For renewal of Registration (i) If the application for renewal is made before the expiry of the validity of a certificate: Fee Rs. 15. Once an application for renewal has been made in time. Registering and Advertising) Rules. Once the application is complete and has been evaluated it is placed before the Registration Board for its orders. 1976. the registration continues to be in force till the decision on the application.1) An application for registration of a drug to be manufactured locally is made in a prescribed Form-5 under the Drugs (Licensing.15. A registration may be suspended or cancelled or renewal denied if the holder of the registration fails to comply with the conditions of registration.000/Rs. after which it is renewable on an application. It takes 3-6 months to process the applications for branded generic drugs and 6-12 months in respect of new molecules.000/- 6 . The respective offices evaluate the application. The Registration Board also considers these opinions.

regulates the import. 8. For substances having strong misuse potential. product specification.Type of Drug Drug for import Drug for local manufacture including galenicals (ii) Type of Drug Drug for import Drug for local manufacture including galenicals · Fee Rs. 1000/application i. export. 8. 7. The Secretary Health presides over this Board. 7. 4. THE DRUGS APPELLATE BOARD Any person aggrieved of any decision of the Central Licensing Board or the Registration Board may prefer an appeal to an Appellate Board constituted for that purpose. Psychotropic substances and against illicit traffic in Narcotic drugs and psychotropic substances. of controlled substances. QUALITY CONTROL The manufacturing of quality drugs is primarily the responsibility of the manufacturer and for that matter every pharmaceutical unit establishes its own quality control laboratory. packing materials including change of labeling specification. etc.000/- Variance to registration Rs. Pakistan being signatory to UN Conventions on Narcotic drugs. consumption of previous imports is certified by the officer of the Ministry before allowing fresh import. 6. change in inactive raw materials.500/Rs.000/Rs. Inspectors of Drugs at the Federal as well as Provincial 7 .000/- If the application for renewal is made within sixty days after the expiry of the validity of a certificate: Fee Rs. testing method / quality specification. SALIENT FEATURES OF POLICY OF ALLOCATION OF CONTROL SUBSTANCES.e. etc. manufacture. The Government regularly monitors the quality of drugs manufactured and marketed. etc. method of manufacture. The annual quota of such substances for import by a pharmaceutical manufacturer having a valid Drug Manufacturing License and registration of such drugs is fixed and consumption of these materials are monitored by authorized officer of the Health Ministry. 15.

In case a drug fails to comply with standards and/or conditions of registration it may result in the cancellation or suspension of a Drug Manufacturing License or registration or legal proceedings in a Drug Court. For that purpose Drug Testing laboratories are established at the Federal as well as Provincial levels. BULK RAW MATERIAL MANUFACTURE The pharmaceutical industry in Pakistan is presently importing a large number of pharmaceutical raw materials with a cost. as the case may be. both oral and sterile. 1978. etc. Ampicillin Anhydrous. etc. 10. It collects Central Research Fund and convenes the meetings of Expert Committee for fund allocation to individuals and/ or Institutions. which are engaged in research in the field of pharmacy and medicine. Presently the following raw materials are being manufactured locally.. Amoxycillin Trihydrate. before deduction of income tax. For these a transparent system of price revision has been developed allowing periodic across-the-board price increases on account of the general rate of inflation and changes in the exchange rate of the rupee. 9. as the case may be. RESEARCH AND DEVELOPMENT Every licensee is suppose to contribute 1% of his gross profit. towards a Central Research Fund maintained by the Federal Government. which is increasing rapidly. for commercial sale. a more liberal system is in operation through which higher price increases are allowed at regular intervals compared to the controlled category of drugs. Cephalosporins like Cephradine and Cephalexin. like Ampicillin Trihydrate. The Central Licensing/Registration Boards or the Provincial Quality Control Board. The applicant desirous of getting fund allocated applies on FormA or Form B. 8 .level conduct post-marketing surveillance. · · Penicillin and its derivatives for oral dosage forms. About 800 drugs that have been considered essential for this purpose have been placed on the controlled list. In case of decontrolled category. for taking further action evaluate reports of the Government Analysts. The Committee evaluates the projects and makes recommendations for funds allocation to the Government. DRUG PRICING The system of pricing of medicines has been liberalized. Research and Development section executes its work under the Drugs (Research) Rules. All drugs have been divided into two categories controlled and decontrolled drugs. The government's determination towards achieving self-sufficiency backed by a liberal policy is encouraging expansion of industrialization towards basic manufacture of pharmaceutical raw materials. 11.

is importable at 5% customs duty. he may be granted a tariff protection on the recommendations of the National Tariff Commission. Other products like Pyrazinamide. pk> Ü 9 . In many cases the statutory rate of duty is only 5%. (SRO 372 (I)/ 2002 dated 15. ntc. the chemical raw material are exempted from custom duty in excess of 5% ad valorem and sales tax. Rifampicin and Sulphamethoxazole This sector is wide open with tremendous opportunities for investment. Ephedrine HCl. < www. Steroids like Betamethasone.gov. both the active and the inactive are exempted from custom duty in excess of 10% ad valorem and sales tax. Hyoscine. sales tax is levy-able on the packing material.6. BULK RAW MATERIAL MANUFACTURE Ü Ü Ü The machinery and equipment. not manufactured locally. Furazolidone. Dexamethasone and their salts. INCENTIVES FORMULATION: Ü For Formulation of dosage forms the pharmaceutical raw materials. 12. 2002) The packing materials also enjoys this benefit however. For bulk manufacturing of pharmaceutical raw materials. (SRO 372 (I)/ 2002 dated 15.6. 2002) Once a local manufacturer of bulk pharmaceutical raw material is capable of meeting the required standards of quality and the domestic requirement. Paracetamol and Ibuprofen. Pseudo-ephedrine HCL. Quinolones like Norfloxacin and Ciprofloxacin.· · · · Analgesics like Aspirin.

13 -I Drugs Controller-II Dr. Faqeer Muhammad Sheikh 10 . Mr.

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KARACHI Phone: 92-21-5060221-35 Fax: 92-21-5060360 E.A. M. Sector 22. KARACHI Phone: Fax: 92-21-5211773 92-21-5675608 Pharma Bureau (A group of multinationals operating in Pakistan) Head Office: Rooms 16 & 17. Plot 23. Club Road. Korangi Industrial Area. Jinnah Road. ORGANIZATIONS OF TRADE AND INDUSTRY Pakistan Pharmaceutical Manufacturers Association Head Office: 130-131 Hotel Metropol.14. 2438091 92-21-2443784 PAKISTAN ZINDABAD 13 .net Pakistan Chemists and Druggists Association Head Office: 18-Shaikh Chambers. (Ground Floor). Near Light House Cinema. KARACHI Phone: Fax: 92-21-2435606.mail: zhmpbk@attglobal.

Contents Page PHARMACEUTICAL SECTOR IN PAKISTAN THE DRUGS ACT 1976 (SALIENT FEATURES) DRUGS CONTROL ORGANIZATION MANUFACTURING OF DRUGS REGISTRATION OF DRUGS SALIENT FEATURES OF POLICY OF ALLOCATION OF CONTROL SUBSTANCES THE DRUGS APPELLATE BOARD QUALITY CONTROL DRUG PRICING RESEARCH AND DEVELOPMENT BULK RAW MATERIAL MANUFACTURE INCENTIVES DRUGS CONTROL ORGANIZATION-CONTACTS ORGANIZATIONS OF TRADE AND INDUSTRY 1 1 3 3 5 7 7 7 8 8 8 9 10 13 .

.*The encircled area indicates the area of concentration of Pharma industry.

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