Drugs Act, 2035 (Act No. 21 of 1978).

This Act provides for the establishment of drugs administration, regulation of manufacture, sale, distribution, export and import of drugs and related matters. Chapter 2 constitutes the Drugs Advisory Council, to advise the government on theoretical and administrative matters, and the Drugs Advisory Committee, to advise the Department of Drugs Administration on technical matters. Chapter 3 establishes the Department of Drugs Administration (Department) for implementation of the Act and the Drug Research Laboratory to perform scientific research, testing and analysis of drugs.
Chapter 4 contains provisions relating to manufacture, sale, distribution, export and import of drugs. It requires a licence to be obtained before manufacture of a drug and registration of such drug. Chapter 5 regulates the quality standard of drugs and prohibits manufacture, sale, distribution, export, import, storage or consumption of drug not conforming to prescribed standards. Chapter 6 provides for powers of inspector and qualifications of inspectors and analysts. Chapter 7 prohibits adulteration of drugs and sale of date expired drugs. It requires licence to be obtained from Department for clinical trial of new drug. It states that narcotic and poisonous drugs must be kept safely and requires that the records of sale or distribution must be maintained by the person selling or distributing.