Department of Drug Administration Nepal (DDA): 10 secrets That Will Amaze You

Department of Drug Administration (DDA)

In 1979 A.D. (2036/07/01 B.S.), the Nepali government established the Department of Drug Administration (DDA). It was previously under the Ministry of Forest & Soil Conservation, but after Poush in 2041 B.S., it became part of the Ministry of Health and Population. Under the Ministry of Health & Population, DDA is one of the three departments. 

Role of DDA

The role of the DDA is to regulate all functions relating to drugs, like misuse and abuse of drugs and their raw materials, to stop false and misleading advertisements, and to ensure the public has access to safe, effective, and high-quality medications by managing their manufacture, marketing, distribution, sale, import, export, storage, and use.

Regional Offices

DDA has three regional offices in Biratnagar, Birgunj, and Nepalgunj. These offices carry out the functions of regular inspection, registration, and renewal of pharmacies. They also act as coordinating centers to work according to other functions mentioned in the Drugs Act 2035 and directions given by DDA.

DIVISIONS OF DDA

A. Registration Division

1: Import and Export:

• To register the foreign pharmaceutical manufacturing business and its scientifically approved products for import.
• To provide a letter of recommendation for the import or export of pharmaceuticals
• to extend the import-export recommendation letter.

2. Industry Section:

• To issue recommendation letters for establishing the pharmaceutical industry and issuing and renewing Product Manufacturing licenses.
• The pharmaceutical manufacturing plant layout should be reviewed and approved. 
• After evaluating them, the sales and distribution of the new products are approved.
• Issue a letter of recommendation for the import and renewal of raw materials.

3. Pharmacy Registration Section:

• To certify, issue, and renew registration certificates for pharmacies that sell retail and wholesale.
• Certificates for individuals permitted to sell medications are issued and renewed (Vyabashahi).
• Update the record of pharmacies.

B. Management Division

1. Training and Drug Information Section:

• Conduct the refresher training for medicine sellers.
• Disseminate information about medicines, particularly adverse effects, contraindications, drug Interaction and storage conditions, and other necessary information regarding medicines.
• Publish the Drug Bulletin of Nepal (DBN) to health institutions, industries, medical doctors, health personnel, pharmacists, and other concerned persons and institutions.
• Recommend for import of narcotic, psychotropic, and precursor substances and liaise with the International Narcotic Control Board (INCB). with
• Conduct activities related to Pharmacovigilance and Adverse Drug Monitoring Reporting.

2. Planning section:

Prepare yearly planning for activities conducted by DDA and the regional office.

Coordinate with the Ministry, other departments, and other government and non-government organizations for conducting activities and submit the report to МОН.

Collect, prepare, and forward monthly, quarterly, and yearly reports.

3. Administration section

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

C. Inspection Division

1. Inspect drug industries and wholesale and retail pharmacies regularly.

2. Take legal and administrative action on non-compliance cases as per the Drug Act and its Regulations provision.

3. Regulate sales and distribution of psychotropic and narcotic drugs.

4. Coordinate Good Manufacturing Practice Audits within and outside the country.

Industry inspection section:

Inspection of the pharmaceutical industry is as per the yearly plan.

Take action for non-compliance related to the Drug Act 2035.

Law section

Prepare necessary medicine-related documents for registering the case in court against pharmacy and industry or order issues regulated by DDA.

Give legal suggestions to the department.

Import/export section: Inspection for the effective implementation of the Drug Act 2035 and other regulations under the Drug Act.

Audit section: WHO GMP certification and Recertification related activities.