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. The name Royal Drug Research Laboratory (RDRL) was changed to National Medicines Laboratory (NML) by the government in the year 2006. It has various sections like Quality Control & Management Section, Testing & Analysis Section, Biological Section, Microbiology Section, Administration and Documentation Unit, Quality & Method Validation Section. NML is constantly thriving to bring out transparency, accountability, impartiality and uniformity in its services in order to ensure safety, efficacy and quality of the medicines manufactured, imported and distributed in the country to help achieve the objectives of Drug Act 2035.
To protect and promote public health in Nepal by becoming an internationally recognized center of excellence for the quality control and research of medicines, cosmetics and medical devices.
To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. To carry out the required tests and analysis and conduct research to ensure that medicines and medical devices used in Nepal meet national and international quality requirements so as to ensure patient safety.
Activities of NML
- Test and analyze the quality of drug as empowered according to the Drug Act 1978.
- Analysis of regulatory drug samples submitted by DDA collected during the process of inspection and investigation by authorized inspectors and public complaint sample submitted by DDA.
- Analytical Method Validation of Non-Pharmacopoeial Products.
- Post market intervention and quality monitoring of drugs.
- Analysis of drug from Government, non-government and private organizations.
- Providing technical service in pharmaceutical field.
- Facilitates different institutions for observation cum interaction.
- GLP Audit of private analytical laboratory and quality control laboratories of pharmaceutical industries.
- Check and evaluate the standard of drug testing laboratories in the country as per “WHO good practices for pharmaceutical quality control laboratories” and “WHO good practices for pharmaceutical microbiology laboratories”
- Conduct training on Good Laboratory Practices (GLP) for national pharmaceutical industries and laboratories.
- Participation in the proficiency testing (PT)/Inter Laboratory Comparison (ILC).
- Biological products lot release certification.
- Research and Development
The main functions of NML are
- Test and analyze the quality of drug as empowered according to the Drugs Act, 1978.
- Check & evaluate the standard of drug testing laboratories in the country.
- Develop reference standard and make available to the pharmaceutical industries & laboratories.
- Conduct training on Good laboratory practices.
- Audit laboratories of National Pharmaceutical industries.
Testing Service Provided
- Hardness Test
- Friability Test
- Optical rotation
- Disintegration Test
- Uniformity of content
- Uniformity of Dispersion
- Dissolution Test
- UV spectrophotometer
- Heavy metals
- Water determination
- Endotoxin testing
- Sterility testing
- Microbial limit test
National Medicines Laboratory
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