Role of DDA

The role of DDA is to regulate all functions relating drugs like misuse and abuse of drugs and its raw materials, to stop false and misleading advertisement and make available safe, efficacious and quality drugs to the general public by controlling the production, marketing, distribution, sale, export, import, storage and use of drugs. The overall activities are described in the table below:


Scope/Key functions


Ensuring safety, quality and efficacy of medicines

· Evaluation, Registration and licensing of medicines and health technology products,

· Issuance of permit to conduct clinical trial, licenses to open pharmacy and recommendation letter to establish manufacturing unit,

· Post marketing surveillance on medicines and health technology products,

· Inspection and monitoring of facilities engaged in manufacture, sales, store and distribution of medicines and health technology products,

· Testing of medicines and HTP before and after registration


Promotion of Rational Use of Medicines and health technology products

· Development and revision of national essential medicines list,

· Development and revision of antibiotic prescription protocol,

· Information dissemination to consumer on rational use of medicines


Ensuring access to medicines and health care technology products

· Formulate medicine policies to ensure access to medicines

· Price regulation and price transparency

· To issue permit for products in shortage (including orphan drugs)


Enforce provisions of drug law for regulatory compliances

· Conduct medicine law awareness activities

· Develop standards and guidelines on medicine registration, pharmacy operation (including hospital pharmacy)

· Train drug inspector to effectively enforce drug law


Institutional development including HR

· To review organizational status and develop institutional development plan

· Develop training material for regulatory and analytical staff at all level

· Conduct capacity development activities like building/construction, renovation and training of HR

· Develop capacity strengthening plan of professional in public as well as private sector engaged in medicines and health technology product manufacture, sales, storage and distribution.

· Develop transparent, responsive service delivery system (including online registration, webpage and communication)

Citizen Charter

Visit our citizen charter section for information on basic rules & regulation to acquire our service.

View Citizen Charter

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