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DDA-Manufacturers interaction to strengthen the Pharmaceutical Quality System

Kathmandu, September 9, 2023

In the valued presence of Advisor to Honorable Health and Population Minister Mr. Bishworup Khadka, the department proudly announces that it conducted an interaction program with the technical Personnel’s (Quality Assurance division) of Domestic Pharmaceutical Industries to help strengthen the Overall Pharmaceutical Quality System.

The major objective of the interaction program was to update the manufacturers mainly Quality Assurance personnel on the amended provisions of the codes on National GMP updated provisions on product registration and marketing authorization.

The interaction was first of its kind and it was preceded by total five sessions where the Senior Drug Administrators from DDA and National Medicine Laboratory gave an insight on amended codes on National GMP, Updates and provisions on registration and marketing authorization, common deficiencies from regulatory inspection, NML-industry activities, method validation and findings from GLP audit, DAMS: issues and challenges. The annexures of amended codes on National GMP was disseminated to the manufacturers for review and to send the department if there are any relevant comments within 15 days via DDA’s official email info@dda.gov.np so that the department can proceed for finalizing the annexes.

The interaction was participatory and there was fruitful discussion after each session and the DDA officials addressed most of the queries of the participants. The issues faced by the manufacturers while using DAMS were noted with the department being committed to solve the issues after internal discussion. The closing remarks were delivered by Director General Narayan Prasad Dhakal. He emphasized on a much wider role of Quality Assurance personnel’s not limiting to the industry only but also to the supply chain part like Storage, transportation to ensure medicines quality remains intact when it reaches its consumers. He also planned ahead activity to conduct Continual Regulatory Education (CRE) on an e-learning platform whereby the manufacturer’s queries can be addressed by experts via online webinar/meeting.

We would also like to express our sincere gratitude to Advisor to Honorable Health and Population Minister Mr. Bishworup Khadka for his encouraging words along with senior drug administrators and officers from DDA, NML, all the technical representatives from the manufacturers, USAID PQM+ for their assistance in making this event a success.