नेपाल सरकार - स्वास्थ्य मन्त्रालय
(+९७७) ०१ ४२६२५४३, ४२६२८०२, ४२६२६९६, ४२६७३७६

अाैषधी व्यवस्था बिभाग

Department of Drug Administration (DDA), established in 1979, is the national drug regulatory authority mainly responsible for regulating production, import export, sale and distribution of medicines and other Health Technology Products (HTP) all across the country. DDA governs all the regulatory functions relating modern, veterinary and traditional medicines. It functions to prohibit misuse and abuses of medicines and its raw materials, to prohibit false and misleading information related to the efficacy and use of medicine, and make available safe, efficacious and quality medicine to the general public by regulating and controlling the production, marketing, distribution, sale, export-import, storage and use of medicines and HTP.

Overall scope of the DDA include regulation of manufacture, import/ export, sale and distribution of medicines and HTP, promotion of safety, efficacy and quality of medicines, prohibiting the misuse and abuse of medicines and promotion of rational use of medicines in accordance with Drug Act 1978 (2035BS). The following key regulatory instruments and codes are enforced by DDA for the regulations of the pharmaceutical production, import export and sales:

·        Constitution of Drug Consultative Council and Drug Advisory Committee rules 2037BS

·        Drug Registration Rules 2038 BS

·        Drug Enquiry and Inspection Rules 2040 BS

·        Drug Standard Rules 2043 BS

·        Codes on sales and distribution 2071 BS

·        Codes on good manufacturing practices 2072 BS

DDA has three Regional Offices and National Medicine Laboratory in addition to the central office in Kathmandu.

Programme Components

Scope/Key functions

1

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

2

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,

·        Training of prescriber, health care providers, pharmacist/vyabasayi and consumer on rational use of medicines

·        Monitoring medicine use and quantification of therapeutics

·        Communication through different mass media on rational use of medicines and health technology products

3

Ensuring access to medicines and health care technology products

·        Formulate medicine policies to ensure access to medicines

·        Price regulation and price transparency

·        Study of pharmacoepidemiology and pharmacoeconomic

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

4

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

5

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)

 

      Narayan Prasad Dhakal

       Director General

 Contact Details:

 Bijulbazar,

 New Baneshwor, kathmandu

 T: 4780 227, 4780432

 F: 4780572

 E: info@dda.gov.np

 W: dda.gov.np