Lucknow-based Central Drug Research Institute (CDRI), under the Council of Scientific and Industrial Research (CSIR), is one of the leading laboratories working in the field of drug research. This CSIR lab has got a certification for its Good Laboratory Practice (GLP) For drug discovery and research, CDRI became the first laboratory to have GLP-certified safety pharmacology facility and the third government laboratory to get this GLP certification.
GLP-compliance certification is voluntary in nature. Test facilities dealing with different chemicals and looking for approval from regulatory authorities before marketing them, prefer to obtain GLP Certification for easy acceptance of data by the regulatory bodies. It enhances the reliability and acceptability of data generated in such facility worldwide.
Therefore, the significance of CDRI getting GLP certification is that the drug development data generated by the Institute will now have acceptability in all countries of the Organisation for Economic Co-operation and Development (OECD), including USA.
CDRI became the first laboratory to have GLP-certified safety pharmacology facility and the third government laboratory to get this GLP certification.
CDRI is already a GLP-certified test facility for Acute Toxicity and Safety Pharmacology since October 2017. Now the institute has got certification for a few more facilities for Toxicity and Mutagenicity Studies such as Bacterial Reverse Mutation (AMES) test, Micronucleus assay and repeat dose Toxicity studies under GLP Certification of National GLP Compliance Monitoring Authority (NGCMA) under the Department of Science and Technology (DST).
A number of countries require robust data generated through GLP facilities about pharmaceutical products, food and feed additives, medical devices, etc. prior to licencing and manufacturing. “Data generated at a GLP facility establish that use of these chemicals does not pose any hazards to human health and the environment.
Regulatory authorities of the concerned countries including India recognise and accept data from the facilities having certification for GLP,” said Dr Tapas Kumar Kundu, Director, CDRI. India Science Wire