National Medicines Laboratory (NML), was established in 1964 A.D. as “Royal Drug Research Laboratory” under Department of Plant Resources, Ministry of Forest, Soil and Conservation. In 1993 A.D., NML was kept as separate organization under Department of Drug Administration, Ministry of Health & Population. Royal Drug Research Laboratory (RDRL) was named as “National Medicines Laboratory” in 2006 A.D. headed by Director. Drug Act 1978: Chapter 3(Research and control of Drugs), Clause 6 states RDRL established by Government of Nepal shall be the principal body of Government of Nepal to perform scientific research, testing and analysis of drugs.
The main activity of NML is to carry out the testing, analysis of regulatory drug, pre-marketing and post market surveillance drug and drug from other organizations (Government institutions, hospital and other organization) in order to deliver safe, effective, and quality medicines to the public as per the provisions of the Drugs Act 2035. NML also perform Lot Release Certification and Lot Verification of the vaccines and Biological Products. Besides monitoring of the quality of marketed products, NML extends its role to the audit of different independent private analytical laboratories and quality control laboratories of domestic pharmaceutical manufacturers. NML also facilitates different Pharmaceutical sciences academic institutions for observation and interaction.
For the analysis of the non pharmacopoeial drug, DDA has constituted “Analytical Method Validation Committee for Non Pharmacopoeial Product” in NML according to Drug Standard Regulation, 1986. The committee has prepared Guideline on Analytical Method Validation on Non-Pharmacopoeial Products for Regulatory Approval in order to recommend a non pharmacopoeial test method to DDA for approval from Drug Advisory Committee. The main role of committee is to strengthen the national quality assurance system regarding the non pharmacopoeial drugs.
Due to lack of availability of adequate human resource, physical infrastructure and adequate budget, the scope of NML is limited to human Allopathic drugs only. NML should expand its scope of activities to the quality assurance of Ayurveda, Veterinary & traditional medicines. Establishment of the biological testing facilities and competent human resources development should be done to monitor the marketed biological product. The hidden activities of NML according to Drug Act, 2035 i.e. Scientific Research of drugs should be emphasized to develop and validate the non pharmacopoeial methods regarding the adulteration of drugs and also the development of Nepal compedial method i.e. Nepal Pharmacopoeia. NML should also magnify its role and responsibility in the analysis of the Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products. Policy & Programme of Fiscal Year 2077/78 state the concept of Department of Drug Administration (DDA) to Food and Drug Administration (FDA). In this regard, NML should be prepared for the strengthening of the testing facilities and competent human resources for the medical devices, diagnostic products and safety issues related to food. Now the country is in the state of federalism, so it’s time to do expansion of NML in federal concept to assure the quality of medicines all over the country.
Since NML is the only National Control Laboratory of the country, its reliability and accuracy of test results has the greatest impact on the quality of local, imported and exported medicines. NML has initiated the necessary preparation for accreditation. ISO 17025:2017 accreditation is huge milestone for NML to deliver quality services to ensure quality medicines and thus to safe guard the health of the Nepalese citizen.
