India has been designated the ‘Vice-Chair’ of Good Laboratory Practice (GLP) Working Group of the Organisation for Economic Co-operation and Development (OECD), recognising the contribution of the Indian GLP programme.
What is Good Laboratory Practice (GLP)?
GLP is a quality system, which has been evolved by OECD to ensure that safety data generated on various chemicals like industrial chemicals, pharmaceuticals (Human and Veterinary), agrochemicals, cosmetic products, food/ feed additives, and medical devices, etc., can be relied upon by regulatory authorities.
Various initiatives of India regarding GLP and OECD
- The Department of Science and Technology established the National GLP Compliance Monitoring Authority (NGCMA) with the approval of the Union Cabinet on April 24, 2002.
- NGCMA is the National body which grants GLP certification to test facilities (TFs) conducting safety studies on new chemicals of the above-mentioned categories in accordance with OECD Principles of GLP and OECD Council norms.
- The Grant of the first GLP certificate by NGCMA in 2004 was a milestone.
- In the year 2011, India became a full adherent to the Mutual Acceptance of Data (MAD) in the OECD, which was a historical event.
- The MAD status has given global recognition to India’s non-clinical safety data by tremendously augmenting its credibility and acceptability across the globe.
The Mutual Acceptance of Data (MAD) system
- The OECD Principles of Good Laboratory Practice (GLP) ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations.
- The principles have been created in the context of harmonising testing procedures for the Mutual Acceptance of Data (MAD).
- The MAD system helps to avoid conflicting or duplicative national requirements, provides a common basis for co-operation among national authorities and avoids creating non-tariff barriers to trade.
- OECD countries and full adherents have agreed that a safety test carried out in accordance with the OECD Test Guidelines and Principles of Good Laboratory Practice in one OECD country must be accepted by other OECD countries for assessment purposes. This is the concept of “tested once, accepted for assessment everywhere”.
- This saves the chemicals industry the expense of duplicate testing for products which are marketed in more than one country.