DDA Notice Record Keeping of the Production, Import, and Consumption of Pregabalin, Dicyclomine, and Promethazine
The Department of Drug Administration (DDA), Ministry of Health and Population, Government of Nepal, has issued a new regulatory notice requiring manufacturers, importers, distributors, and retail pharmacies to maintain and submit records related to the production, import, distribution, and consumption of Pregabalin, Dicyclomine, and Promethazine.
The decision, made on 22 Jestha 2083 B.S., aims to prevent the misuse of these medicines while strengthening market regulation, monitoring, and ensuring their appropriate availability throughout Nepal.
Key Regulatory Requirements
1. Manufacturers of Pregabalin
Manufacturers must submit records to the Department whenever there is a request to increase the approved production quantity. The submitted information should include:
- Import and consumption data
- Market supply details up to the Retail Pharmacy Level
2. Importers
Importers are required to submit consumption reports every six months, covering distribution and utilization of the medicines up to the Retail Level.
3. Retail Pharmacies
Retail pharmacies must ensure that:
- Pregabalin is dispensed only against a valid prescription issued by a registered medical practitioner.
- Prescription records must be maintained in either soft copy or hard copy.
- The records must include:
- Prescriber’s name
- Nepal Medical Council (NMC) registration number
4. Manufacturers, Importers, and Distributors of Dicyclomine and Promethazine
- Manufacturers and importers must maintain and submit sales and distribution records up to the Distributor Level.
- Distributors must maintain and submit sales and distribution records up to the Retail Pharmacy Level.
Purpose of the Notice
The Department of Drug Administration has introduced these measures to:
- Prevent misuse and abuse of Pregabalin, Dicyclomine, and Promethazine.
- Improve monitoring of the pharmaceutical supply chain.
- Enhance accountability among manufacturers, importers, distributors, and retail pharmacies.
- Strengthen regulatory oversight and ensure responsible dispensing practices.
Important Message for Pharmacists and Pharmaceutical Stakeholders
All pharmaceutical manufacturers, importers, distributors, wholesalers, and retail pharmacies in Nepal are advised to comply with these new documentation and reporting requirements. Retail pharmacies should pay particular attention to the mandatory prescription requirement for Pregabalin and maintain proper prescription records for regulatory inspection.
Source: Department of Drug Administration (DDA), Ministry of Health and Population, Government of Nepal
