Drugs (Federal Inspectors, Federal Drug Laboratory & Federal Government Analysts) Rules, 1976.

These Rules establish the Drugs (Research) regulation. In exercise of the powers conferred by Sec. 43 of the Drugs Act, 1976 (XXXI of 1976), the Federal Government makes the following rules, the same having been previously published as required by subsection (3) of the said section. They establish activities and responsibilities of the Federal Inspector being a person who­: (a) has a degree in Pharmacy; and (b) has not less than ten years' practical experience in (i) manufacture, testing or analysis of drugs, or (ii) drug administration. Subject to the instructions of the licensing authority, it shall be the duty of an inspector to­­: a) inspect all premises licensed for the manufacture of drugs including the plant and the process of manufacture, the means employed for standardizing and testing the drugs, methods and places of storage, location and administration of the establishment likely to affect the purity of products; b) inspect establishment licensed for drugs import, export or sale and control the conditions of the licence are being observed; c) send a report to the licensing authority after inspection indicating the conditions of the licence which are being observed; d) take samples of any suspected drugs being manufactured, stocked, sold in contravention of the provisions of the Act and send them for test; e) investigate any complaint in writing, etc.