Department of Drug Administration (DDA)

Government of Nepal established Department of Drug Administration (DDA) in 1979 A.D (2036/07/01 B.S.) to prohibit the misuse or abuse of medicines and allied pharmaceutical materials as well as the false or misleading information relating to efficacy and use of medicines and to regulate and control the production, marketing, distribution, export-import, storage and utilization of those medicines which are not safe for the use of the people, efficacious and of standard quality.

Department of Drug Administration (DDA) is the government institution which implements and fulfill the aim of Drug Act 1978 and various regulations under the act, Government of Nepal established Department of Drug Administration (DDA) in 1979.

Objectives of Department of Drug Administration (DDA)

The main objective of DDA is to regulate all functions related to the modern, veterinary and traditional medicines, including misuse and abuse of medicines and its raw materials, to stop false and misleading advertisement and make available safe, efficacious and quality medicine to the general public by controlling the production, marketing, distribution, sale, export-import, storage and use of medicines.

Strategies of Department of Drug Administration (DDA)

• Selection of essential medicine to promote rational use of medicines.
• Establishment of regional offices at all five regions for effective decentralization.
• Strengthening of National Medicines Laboratory (NML) as National reference Laboratory on medicines.
• Medicine registration based on scientific facts.
• Promotion of rational use of medicines.
• Development of an efficient drug 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

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 healthcare 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)

Organogram of Department of Drug Administration (Organization structure, division and functions of Department of Drug Administration)

Drug Evaluation and Registration Division;
Medicine and Biological Evaluation Section

• Scientific evaluation of new medicine and allied products for manufacturing, import, export and marketing.
• Scientific evaluation of vaccines and biological for manufacturing, export, import and marketing.
• Research and Development of new medicine and Clinical trials.
• To coordinate with the related experts for the evaluation of new medicine
• To issue permission for research and development and clinical trials.

Import Section

• To approve foreign manufacturer for importation of medicine.
• To register products for export and import after evaluation.
• To issue the recommendation letter for import/export of medicines
• To renew the recommendation letter for import-export.
• To register vaccines and biological for export and import after evaluation.
• To issue recommendation letter for import/export of vaccines and biological.

Industry Section

• To issue recommendation letter for establishment of pharmaceutical industry and issue Product Manufacturing License and renew them.
• To approved layout of pharmaceutical industry.
• Register new products and issue marketing permission for the sale and distribution.
• Issue letter of recommendation for the import of raw materials and renew them.
• To register and issue registration certificates to open retail / wholesale pharmacy outlets and renew them.
• Issue and renew certificates for persons authorized to sale medicines.
• Update the record of pharmacies and approve variation in the licenses.

Planning, Coordination and Management Division;

Training and Drug Information Section

• Conduct the refresher training to medicine sellers.
• Disseminate information about medicines particularly side 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 personnels, pharmacist and other concerned person and institutions.
• Revise National List of Essential Medicines and Nepalese National Formulary periodically.
• Recommend for import of narcotic, psychotropic, precursors substances and liaise with International Narcotic Control Board.
• Conduct activities related to Pharmacovigilance and Adverse Drug Monitoring Reporting.
• Webpage development, updating and computer networking.

Planning and Coordination section

• Organization development, planning, budgeting, foreign aid.
• Central and provincial government coordination and foreign coordination.
• Prepare yearly planning for activities conduct by DDA and regional office.
• Coordinate with Ministry, Department and other government and non government organization for conducting activities and submit the report to Ministry of Health and Population {MoHP).
• Collect, prepare and forward monthly, quarterly and yearly report.

Pharmacovigilance section

• Post marketing surveillance of the Medicine and allied products.
• To act as a National pharmacovigilance center and coordinate and collaborate with regional centers and WHO Collaborating Centre for international Drug Monitoring (The Uppsala Monitoring Centre)
• To facilitate the policy development and design on Drug Use Evaluation.

Financial/Administration section

• Entry and Dispatch of letters.
• Management of human resources (recruitment, posting, promotion, transfer etc)
• Performance evaluation of employees and maintained harmony.
• Perform Procurement related activities
• Monitoring, evaluation and co-ordination of regional offices activities.
• Management of Premises, building, workplaces and Library.
• Internal financial management, revenue collection and audit.
• Plan and prepare budget expenditures.
• Procurement and expenditure management.
• Financial irregularities management (Beruju).

Inspection, Evaluation and Law Enforcement Division

• 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.
• Coordinate Good Manufacturing Practice Audit within and outside the country

Inspection and Evaluation Section

• Inspection for the effective implementation of Drug act 2035 and other regulations under Drug Act.
• Inspect drug industries, wholesale, retail and hospital pharmacies regularly.
• Prepare indicators for inspection and evaluation.
• Prepare national standards for inspection of Drug Industry and Pharmacies.
• Set an annual target for inspection and evaluation.
• Assist on periodically and annual review.

Law Enforcement Section

• Prepare necessary document for registering the case on court against Drug Act.
• Assist on legal aspect to Department.
• Training to Drug Inspectors on Inspection, Investigation and Case filing.
• Surveillance on legal aspects related to pharmacy practice.
• Assist on the amendment of Drug act, Regulation and Guidelines.
• GMP Audit and Certification Section
• Perform GMP certification and Recertification related activities.
• Inspection of pharmaceutical industry as per plan.
• Coordinate with regional offices for GMP related inspection.
• Prepare work plan for foreign industry Audit inspection
• Take action for noncompliance.

National Medicines Laboratory (NML)

National Medicines Laboratory is the principal body of Government of Nepal for testing and analysis of drugs. It has various sections like chemical analysis, microbiology, pharmacology and instrumental analysis.

The main functions of NML are to:

• Test and analyze the quality of medicines as empowered according to the Drug Act 1978.
• Issue Lot Release Certificate for vaccines.
• Conduct training on Good Laboratory Practices.
• Audit laboratories of Nepalese pharmaceutical industries.

For updated information, please visit official website of DDA

Contact

Bijulibazar, New Baneshwor, Kathmandu, Nepal
Tel: (977) 1 4780 227, 4780432
Fax: (977) 1 4780572
Email: [email protected]

Recommended

• The Ministry of Health and Population (MoHP), Nepal
• Department of Ayurveda and Alternative Medicine (DoAA)

Information was collected from various documents, reports and government publications. 

Recommended Citation: Public Health Update. Department of Drug Administration (DDA), Ministry of Health and Population [Internet]. [cited 2020 Jul 1]. Pokhara. Nepal. Available from: https://www.publichealthupdate.com/department-of-drug-administration-dda-ministry-of-health-and-population/

Related readings

• Department of Drug Administration (DDA)
• List of Domestic Industries listed in DDA DAMS
• WHO GMP Certified Pharmaceutical Companies in Nepal
• List of Narcotics and Psychotropic Substances identified for Import and Use in Nepal
• Pharmacovigilance Network in Nepal
• Drug and Medicine Related Act, Rules, Regulations, Policies, Guidelines & Directives in Nepal
• New Drug Registration Process & Format of Documents for Import in Nepal