Department of Drug Administration (DDA)

Government of Nepal established Department of Drug Administration (DDA) in 1979 A.D (2036/07/01 B.S.) 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

Mission & Vision of Department of Drug Administration (DDA)

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

Under the Drug Act 1978, the following rules and regulation and codes have been implemented as supporting tools for the active enforcement of Drug Act 1978. Regulation on Constitution of Drug Consultative Council and Drug Advisory Committee, 2037 Drug Registration Regulation, 2038 Interrogation and Inspection Regulation, 2040 Codes on Drug Manufacturing, 2041 Drug Standard Regulation, 2043 Drug Donation guidelines have been implemented for the quality assurance of donated drugs.

Role of Department of Drug Administration (DDA)

The role of DDA is to regulate all functions relating drugs like misuse and abuse of drugs and its raw materials, to stop false and misleading advertisement and make available safe, efficacious and quality drugs to the general public by controlling the production, marketing, distribution, sale, export, import, storage and use of drugs. The overall activities are described in the table below:

Ensuring safety, quality and efficacy of medicines
- Evaluation, Registration and licensing of medicines and health technology products,
- Issuance of permit to conduct clinical trial, licenses to open pharmacy and recommendation letter to establish manufacturing unit,
- Post marketing surveillance on medicines and health technology products,
- Inspection and monitoring of facilities engaged in manufacture, sales, store and distribution of medicines and health technology products,
- Testing of medicines and HTP before and after registration
Promotion of Rational Use of Medicines and health technology products
- Development and revision of national essential medicines list,
- Development and revision of antibiotic prescription protocol,
- Information dissemination to consumer on rational use of medicines
Ensuring access to medicines and health care technology products
- Formulate medicine policies to ensure access to medicines
- Price regulation and price transparency
- To issue permit for products in shortage (including orphan drugs)
Enforce provisions of drug law for regulatory compliances
- Conduct medicine law awareness activities
- Develop standards and guidelines on medicine registration, pharmacy operation (including hospital pharmacy)
- Train drug inspector to effectively enforce drug law
Institutional development including HR
- To review organizational status and develop institutional development plan
- Develop training material for regulatory and analytical staff at all level
- Conduct capacity development activities like building/construction, renovation and training of HR
- Develop capacity strengthening plan of professional in public as well as private sector engaged in medicines and health technology product manufacture, sales, storage and distribution.
- Develop transparent, responsive service delivery system (including online registration, webpage and communication)

Strategies of Department of Drug Administration (DDA)

Selection of essential medicine to promote rational use of medicines.
Establishment of provinces offices for effective decentralization.
Strengthening of National Medicines Laboratory (NML) as an Independent National Medicine Control Laboratory.
Medicine registration based on scientific facts and evidence of safety, efficacy and quality of medicine.
Promotion of rational use of medicines.
Development of an efficient medicine information system to disseminate the relevant information.
Encouragement to promote and establish pharmaceutical industries to achieve self-reliance in the production of essential medicines.
Effective inspection to ensure the quality of marketed medicines.
Prevent misuse of antibiotic to combat antimicrobial resistance.
Strengthen national industry to comply with WHO-Good Manufacturing Practices (GMP)

Division of Department of Drug Administration (DDA)

Registration Division

Import and Export Section:

- To register the foreign medicine manufacturing company and products in a scientific manner for import.
- To issue the recommendation letter for import/export of medicine.
- To renew the recommendation letter for import-export.

Industry Section:

- To issue recommendation letter for the establishment of pharmaceutical industry and issue Product Manufacturing License and renew them.
- Check and approve the pharmaceutical manufacturing plant layout.
- Evaluate the new products and issue marketing permission for the sale & distribution.
- Issue letter of recommendation for the import of raw materials and renew them.

Pharmacy Registration Section:

- To register and issue registration certificates for retail / wholesale pharmacy outlet and renew them.
- Issue and renew certificates for persons authorized to sale medicines (Vyabashahi).
- Update the record of pharmacies.

Management Division

Training and Drug Information Section:

- Conduct the refresher training to medicine sellers.
- Disseminate information about medicines particularly adverse effects, contraindication, drug Interaction and storage condition and other necessary information regarding medicines.
- Publish Drug Bulletin of Nepal (DBN) and distribute to health institutions, industries, medical doctors, health personnel’s, pharmacists and others concerned person and institution.
- Recommend for import of narcotic, psychotropic, precursors substances and liaise with International Narcotic Control Board (INCB).
- Conduct activities related to Pharmacovigillance and Adverse Drug Monitoring Reporting.

Planning section:

- Prepare yearly planning for activities conduct by DDA and regional office.
- Coordinate with Ministry, other department and other government and non government organization for conducting activities and submit the report to MOH.
- Collect, prepare and forward monthly, quarterly and yearly report.

Administration section:

- Management of human resources (recruitment, posting, promotion, transfer etc)
- Perform Procurement related activities  Monitoring and evaluation of regional offices activities.

Inspection Division :
- Inspect drug industries, wholesale and retail pharmacies regularly.
- Take legal and administrative action on cases of non-compliance as per the provision of Drug Act and its Regulations.
- Regulate sales and distribution of psychotropic and narcotic drugs.
- Co-ordinate Good Manufacturing Practice Audit within and outside the country.
- Industry inspection section
- Inspection of pharmaceutical industry as per yearly plan.
- Take action for noncompliance related to Drug Act 2035.

Law section:

- Prepare necessary medicine related document for registering the case on court against pharmacy and industry or order issues regulated by DDA
- Give legal suggestion to department.

Import/export section: