Government of Nepal established Department of Drug Administration (DDA) in 1979 A.D (2036/07/01 B.S.) erstwhile under Ministry of forest & soil conservation and went under Ministry of Health and population after Poush, 2041 B.S. DDA is one of the three departments under Ministry of Health & Population.

Nepal has promulgated the Drug Act 1978, to prohibit the misuse or abuse of medicines and allied pharmaceutical products as well as false or misleading information relating to efficacy and use of drugs and to regulate and control the production, marketing, distribution, export, import, storage and utilization of those drugs which are not safe for the public use, efficacious and of standard quality. To implement & fulfill the aim and objectives of Drug Act 1978 and various regulations are made under it.

In accordance with the objectives of the National Health Policy, 1991, to improve & manage by establishing co-ordination among governmental, non-governmental & private organizations involved in activities related to medicine production, import, export, storage, supply, sales, distribution, qualitya ssessment, regulatory control, rational use and information flow, the National Drug Policy, 1995 has been implemented. Achieving the aim & objectives of National drug policy is another important area for DDA.

Under the Drug Act 1978, the following rules/regulations & codes have been implemented as supporting tools for the active enforcement of Drugs Act, 1978.

• Drug advisory committee & consultative council regulation, 2037
• Drug registration regulation, 2038
• Inquiry & inspection regulation, 2040
• Drug standard regulation, 2043
• Drug donation guidelines have been implemented for the quality assurance of donated drugs
• Drug sales & distribution codes, 2071
• Good practice codes for drug production, 2072
• Medicine registration guidance, 2073