Welcome to National Medicine Laboratory Visit Nepal 2020

Mr. Shailesh Kumar Jha
Acting Director

Message from Director

The main duty of the National Medicine Laboratory is to carry out testing, analysis and scientific research of drugs in order to deliver safe, effective and quality medicines to the public for public consumption as per the provisions of the Drugs Act 2035 and the rules made there under, as well as National Drug Policy 2051 and the National Health Policy 2076. In order to ensure that the medicines are safe, effective and qualitative NML provides testing services from qualified and trained analysts and aims at providing transparency, accountability, impartiality and uniformity in its services.

National medicines laboratory established pursuant to section 6 of Drug Act 2035 is the principle organization to perform scientific research, testing and analysis of drugs. 

Ms. Saraswati Dangol

Quality Controller, Information Officer

About NML

National Medicines Laboratory (NML) established pursuant to section 6 of Drug Act 2035 is the National drug research/control laboratory of Nepal. It is the principal body of Government of Nepal to perform scientific research, testing and analysis of drugs. It functions under the Department of Drug Administration, Ministry of Health and Population. It was formerly known as Royal Drug Research Laboratory (RDRL) and established in 1964 AD under the Department of Plant Resources. The quality control of the drug samples submitted by Department of Drug Administration was performed by a quality control laboratory of RDRL. From the Fiscal Year 1993/94 RDRL was placed under the Department of Drug Administration. 

Latest News & Notices

सूची दर्ता गर्ने सम्बन्धी सूचना २०७८।०३।३१   3 months ago
यस प्रयोगशालाको आ.व.२०७८।०७९ को लागी सार्वजनिक खरीद ऐन २०६३ को दफा छ (क) बमोजिम मौजूदा सूची अध्यावधिक गर्नूपर्ने भएकोले इच्छूक आपूर्तिकर्ता फर्म।कम्पनी।संस्था आदिले सार्वजनिक खरीद नियमावली २०६४ को नियम १८ (१) बमोजिम तोकिएको ढाँचामा यस प्रयोगशालाको जिन्सी शाखामा ...

As per Drug Act 2035, Department of Drug Administration (DDA) can take advice from the drug advisory committee (DAC) to check the safety, efficacy and quality of the drug which are not mentioned in the pharmacopoeias recognized by Schedule 1 of Drug Standard Regulation 2040 and establish the method of analysis for the analysis of such drug products. For this provision of Drug Act, DDA has formed a committee to assist DDA in establishment of analytical method, product (quality control) specification for non pharmacopoeial products.

The committee has so far prepared SOP for study of documents on non pharmacopoeial products for regulatory approval, guidelines for analytical method validation, check lists for analytical method validation for submission of application for registration, check list for evaluation of document submitted by the industry and protocol for the establishment of some of methods of non pharmacopoeial products and quality control specifications. This step will help in development of Nepal Pharmacopoeia too. The standard of drugs then will be as per Nepal Pharmacopoeia.

Nepal Pharmacopoeia has not yet been prepared therefore the standard of drug will be as per the quality control specifications and analytical methods suggested by the committee after the method is approved by DDA/ DAC for non pharmacopoeial drug products.

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