About

DIVISIONS OF DDA

Division of 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 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.

 

---