PAKISTAN DRUG ACT, 1976

The Pharmaceutical manufacture and trade in Pakistan is regulated through the Drug Act 1976, And the rules framed there under. This is a fairly comprehensive law. Pakistan was the first amongst the developing countries in the world to have introduced Good Manufacturing Practices as a mandatory requirement. Registrations are granted by the Central Licensing and Registration Boards.

The first legislation which was promulgated for regulating the import, export, manufacture, storage, distribution and sale of drugs was the Drugs Act, 1940. It was promulgated as a result of a resolution which the legislatures of all the provinces had passed in terms of Section 103 of the Government of India Act, 1935. In this act, essential powers were conferred on the federal government, which related to the constitution of a drugs technical board, a central drugs laboratory, an advisory committee and making rules to implement the provisions of the act. Other powers were conferred on the provincial governments including the power to amend standard quality schedule, prohibit manufacture and sale of certain drugs, appoint government analysts and inspectors and make relevant rules. In Pakistan, the Drugs Act, 1940 was then replaced with the Drugs Act, 1976. The purpose of this act is to regulate the import, export, manufacture, storage, distribution and sales of drugs. In this regard, vital powers are vested with the federal government, including the power to regulate the import and export of drugs, set up a central licensing board for granting licenses, a registration board for registering drugs, the Pakistan National Formulary, an appellate board for the disposal of appeals, committees of experts on evaluation of drugs, a federal drugs laboratory and other institutes and drugs testing and research laboratories as well as drugs courts. Under this law, the centre is also supposed to appoint federal government analysts and inspectors, fix the prices of medicines, and to make rules. The rest of the powers were conferred upon the provincial governments under this act including the power to regulate the sale of drugs, take steps to ensure compliance with the conditions for registration of drugs, set up a provincial quality control board, a provincial drugs testing laboratory, appoint government analysts and inspectors and to make the rules. Since the 18th Amendment has been passed and integrated into the constitution. The Drugs Act, 1976 was promulgated while exercising the powers conferred on the legislature under item 20 of the Concurrent Legislative List of the Fourth Schedule of the constitution of 1973. This item was omitted from the Fourth Schedule as a result of the 18th Amendment. Through this amendment the power to amend the Drugs Act, 1976 has been transferred to the provincial assemblies. Now, these assemblies will work on it according to their needs.

The Drugs Control Organization, Ministry of Health functions mainly as Secretariat of Central Licensing and Registration Boards under the Drugs Act, 1976. The Drugs Act, 1976 comprises Federal and Provincial subjects. The Federal Govt. regulates manufacture, registration, pricing, import and export of drugs. 80% of country’s requirement is being met from the drugs manufactured in Pakistan while 20% requirement is being met from import of drugs. The issues related to regulation of import and export of drugs, establishment of a central licensing board, registration board, a federal drugs laboratory and fixing the prices of medicines will be the provincial subject. However, import and export will be federal subject according to the provisions of the constitution.

Following are the committees which are involved in the registration and monitoring of drugs in Pakistan.

1.      Committee for Monitoring Drug.

2.      Expert Committee on Research & Development.

3.      Expert Committee on Advertising.

4.      Price Review Committee.

5.      Quality Control Committee.

6.      Committee on Biological Drugs.

7.      Veterinary Expert Committee.

8.      Drug Appellate Board.

9.      Central Licensing and Registration Board.