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 medicines
  • 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 :

  1. Inspect drug industries, wholesale and retail pharmacies regularly.
  2. Take legal and administrative action on cases of non-compliance as per the provision of Drug Act and its Regulations.
  3. Regulate sales and distribution of psychotropic and narcotic drugs.
  4. Co-ordinate Good Manufacturing Practice Audit within and outside the country.
  5. 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

  • Inspection for the effective implementation of Drug Act 2035 and other regulations under Drug Act.

Audit section :WHO GMP certification and Recertification related activities.