Policy Update
Manya Marwah
Background
The National GLP Compliance Monitoring Authority (NGCMA) was established on April 24, 2002, by the Department of Science and Technology (DST) under the Government of India. The body is aimed at ensuring that Good Laboratory Practices (GLPs), as put forth by the Organisation for Economic Co-operation and Development (OECD), are enforced on non-clinical laboratory studies. This largely includes research on chemicals, such as pharmaceuticals, cosmetics, and agrochemicals. It is the official regulatory authority that has the jurisdiction to provide GLP certification to industries, test facilities, and laboratories that deal with such chemicals.
The Principles of GLP by OECD describe the responsibilities of various personnel working within a system, such as those of the test facility management, study director, and the quality assurance team. It also sets minimum standards regarding the suitability of equipment required for a particular study, as well as the requirement of standard operating procedures (SOPs), raw data documentation, and creating and archiving records.
India was granted the status of Mutual Acceptance of Data (MAD) in the OECD in March 2011, which implies that data from Indian GLP Test Facilities (TFs) automatically becomes acceptable to the OECD member states and those that are fully adherent to MAD.
Functioning
The NGCMA functions via an Apex Body, which is further supported by a Technical Committee. The Apex Body consists of Secretaries of concerned Ministries and Departments. The Secretary of the Department of Science and Technology is the chairman of the Apex Body by default. The recommending body of NGCMA, i.e. the Technical Committee on GLP, comprises 17 trained GLP Inspectors from Government laboratories, universities and publicly funded institutions. While the Apex Body ensures the functioning of the National GLP Programme according to the OECD principles, the Technical Committee evaluates the technical compliance of the applicant test facility with the principles.
To obtain a GLP certification, test facilities are required to submit the prescribed NGCMA application form and fee. The NCGMA will conduct a pre-inspection of the laboratory, followed by a final inspection. The final decision is taken by the Chairman of the GLP Authority on the recommendation of the Technical Committee. The certification is valid for 3 years.
A GLP Certification can be provided to TFs dealing with chemicals like:
- Physical-chemical Testing
- Toxicity Studies
- Mutagenicity Studies
- Environmental Toxicity
- Studies on Aquatic and Terrestrial Organisms
- Studies on Behaviour in Water, Soil and Air, Bio-accumulation
- Residue Studies
- Studies on Effects on Mesocosms and Natural Ecosystems
- Analytical and Clinical Chemistry Testing
Performance
- At present, more than 50 Indian test facilities across at least 15 states have been GLP certified by the NCGMA, including NIPER (Mohali) and Indian Institute of Toxicology Research (Lucknow), among others. This is up from only 4 TFs in 2004, where the first GLP certification was provided to the International Institute of Biotechnology and Toxicology (IIBAT), Padappai, Tamil Nadu.
- The data produced by GLP-certified Indian test facilities are currently acceptable in 36 OECD member countries and 6 non-member MAD adherent countries. In addition to research acceptability, this status removes technological trade barriers and facilitates the export of chemicals, drugs, and pesticides, among others, to various markets worldwide, including those of the USA, UK, and Japan.
- While there are several, the top three growth drivers of the National GLP Programme include:
1. Mutual acceptance of data in all OECD countries
2. NGCMA’s strong hosting and monitoring of the GLP program
3. High quality and robustness of OECD guidelines - Indian TFs conduct studies specialising in the non-clinical health and environmental safety areas. Studies have noticed that indigenous test facilities focus on pharmaceuticals, pesticides, or agrochemical testing. 86% of Indian TFs test Pharmaceuticals, 78% test Pesticides, and 64% test Industrial chemicals, among others.
Impact
- Studies have estimated approximately 3000 professionals, including scientists, doctors, and students, to be employed in the Indian GLP industry. This workforce is more than double the number of people involved in the industry before India became fully adherent to MAD status in the OECD.
- GLP-certified TFs work towards continuous capacity building and training of its workforce, for which the NGCMA organises training workshops and conferences by in-house experienced employees, in addition to external qualified inspectors and consultants. Between 2013 and 2019, 41 sessions with 2,268 participants were conducted by the NCGMA.
- More than three times the number of GLP studies were undertaken in the country after India’s full adherence to MAD. To elucidate this, 2,961 test studies were conducted in 2010, before India gained MAD status in 2011, as compared to 12,808 studies in 2018. In addition to the number of studies performed every year, the impact of the GLP industry can be studied by analysing the business value of studies conducted. A total INR 7,800 crores (USD 1.3 billion) business value is estimated to be derived from Indian GLP TFs, as of a study dated December 2019.
- The National GLP Program supports the development of allied services, including the supply of equipment, test systems, software, and other services, complementing the ‘Make in India’ scheme to some extent. While approximately 20-25% of TFs suggest complete self-reliance with regard to these services in India, 60-65% of TFs express import dependency for advanced scientific equipment.
Emerging Issues
- The GLP-certified test facilities are concentrated in specific states, such as Maharashtra, Gujarat, and Karnataka. This is predictable due to the existence of pharmaceutical industries and national laboratories in these states. However, Madhya Pradesh, Jammu and Kashmir, Kerala, Sikkim, and many more do not have any GLP-certified laboratories.
- The biggest challenge in performing GLP studies in India is reportedly the non-availability of quality non-rodent test systems. This issue persists for the procurement of large animals to be used for testing. There is also a substantial delay in obtaining resources such as critical reagents and chemicals.
- The processes regarding the import of test systems are complicated and tend to result in loss of potential opportunities and business. Obtaining test licenses and customs clearance for biological samples such as skin and tissues, as well as larger test systems such as dogs, acts as an obstacle for efficient GLP-certified studies.
Way forward
- India is a vast country with a perpetually increasing population. To ensure regionally equitable growth and innovation in this sector, it is recommended that more laboratories be encouraged to obtain GLP certification, especially in those states where there are none. This would ensure accessibility with regard to ethical research and equitable distribution of benefits.
- The scope of GLP certification can be increased by adding more types of test items to be included under GLP. This can include cell therapy products, stem cell research, biotech products, and nanomaterials.
- The NCGMA can be brought into collaboration with other existing certifying agencies under the Government of India for non-clinical testing, such as the CIB, the National Accreditation Board for Testing and Calibration Laboratories (NABL), the ISO, and others. This would include various benefits, such as more efficient communication within these various departments to streamline business for Indian test facilities, as well as the universal acceptance of data generated from facilities and laboratories under these agencies.
References
- Department of Science & Technology. (n.d.). About NGCMA. Government of India. Retrieved from https://dst.gov.in/about-ngcma
- Department of Science & Technology. (2022). Impact analysis report: National GLP programme [PDF]. Government of India. Retrieved from https://dst.gov.in/sites/default/files/Impact%20Analysis%20Report.pdf#page=2.22
- India Science & Technology Portal. (n.d.). National Good Laboratory Practice Compliance Monitoring Authority (NGCMA). Retrieved from https://www.indiascienceandtechnology.gov.in/programme-schemes/research-and-development/national-good-laboratory-practice-compliance-monitoring-authority-ngcma
- Organisation for Economic Co-operation and Development. (n.d.). Good Laboratory Practice and Compliance Monitoring. OECD. Retrieved from https://www.oecd.org/en/topics/sub-issues/testing-of-chemicals/good-laboratory-practice-and-compliance-monitoring.html
- Press Information Bureau. (2022, September 16). India’s GLP program completes 20 years: A global success story. Government of India. Retrieved from https://www.pib.gov.in/PressReleasePage.aspx?PRID=1844717
About the Contributor
Manya Marwah is a Research Intern at IMPRI and is currently in her second year of undergraduate Economics honours at Miranda House.
Acknowledgement
The author would like to thank Ms Aasthaba Jadeja, the IMPRI team, and her fellow interns for their valuable contributions.
Disclaimer
All views expressed in the article belong solely to the author and not necessarily to the organisation.
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