National Medicines Laboratory
The National Medicines Laboratory (NML) is Nepal's National Drug Control Laboratory. It functions under the Ministry of Health and Population. As per the Drug Act 1978, NML is the principal drug testing and analysis organization. Previously, the name of this institute was Royal Drug Research Laboratory (RDRL), which functioned under the Department of Plant Resources. The quality control of the drug samples submitted by the 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 government changed the Royal Drug Research Laboratory (RDRL) to the National Medicines Laboratory (NML) in 2006. It has various sections, such as the chemical, HPLC, and microbiology sections.
Activities of NML
- Test and analyze drug quality as empowered according to the Drug Act 1978.
- GLP Audit of laboratories of pharmaceutical industries.
- Investigate and assess the nation's drug testing lab standards.
- Conduct training on Good Laboratory Practices (GLP) for national pharmaceutical laboratories and industries.
- Participation in proficiency testing
- Vaccine lot release
- Research and Development
- Analysis of drug samples
The drugs that are to be analyzed are obtained from the following sources.
- Samples from the inspection section of DDA.
- Public complaint samples submitted by DDA.
- Samples from the import section of DDA.
- Non-pharmacopoeial drug samples are for analytical method validation before registration in DDA.
- Samples from government organizations, constitutional bodies, investigation authorities, research institutes, industries, etc.
- Samples were collected during post-market surveillance and submitted by DDA.
- Samples collected by NML during the market survey.
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