DIVISIONS OF DDA
Division of DDA
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.
- 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.
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.
- 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.
- 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.
- 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.
- Inspection for the effective implementation of Drug Act 2035 and other regulations under Drug Act.
Audit section :WHO GMP certification and Recertification related activities.