National Medicines Laboratory (NML)

National Medicines Laboratory (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.

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.

Vision / Mission of National Medicine Laboratory(NML)

Vision

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.

Mission

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 National Medicines Laboratory (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

Testing Service provided by National Medicines Laboratory (NML)

Identification
- UV
- IR
- HPLC
Hardness Test
Friability Test
Optical rotation
Disintegration Test
Uniformity of content
Uniformity of Dispersion
Dissolution Test
- UV spectrophotometer
- HPLC
- AAS
Assay
- UV
- HPLC
- Titration
- AAS
- GC
Heavy metals
Water determination
Endotoxin testing
Sterility testing
Microbial limit test
Bioassay

National Medicines Laboratory (NML) provides its testing and analysis facilities through various sections such as:

Testing and Analysis Section (Chemical Unit, Ayurvedic and Alternate Chemical Unit, Instrumentation Laboratory)
Biological Section (Vaccine Unit, Pharmacology and Toxicology Unit)
Microbiology Section
Quality control and management section (Reference standard unit, GLP unit, Proficiency Testing unit)
Quality and Method Validation section

National Medicines Laboratory (NML) Organisational Structure