India has been designated the Vice-Chair of Good Laboratory Practice, GLP Working Group of the Organisation for Economic Co-operation and Development (OECD).
Good Laboratory Practice
- Good Laboratory Practice is a quality system, which has been evolved by OECD to ensure that safety data generated on various chemicals like industrial chemicals, pharmaceuticals, cosmetic products and medical devices can be relied upon by regulatory authorities.
- The Department of Science and Technology had established the National GLP Compliance Monitoring Authority (NGCMA) with the approval of the Union Cabinet on April, 2002.
- NGCMA is the National body which grants GLP certification to test facilities conducting safety studies on new chemicals of the mentioned categories in accordance with OECD Council norms.
- The spectrum of activities of Indian GLP TFs is wide, involving eight (8) types of chemicals/test items and nine (9) areas of expertise. The National GLP program has not only helped to build a network of GLP TFs in the country but also created a huge quantum of highly competent human resources.
Mutual Acceptance of Data (MAD)
- On March 3, 2011, India became full adherent to the Mutual Acceptance of Data (MAD) in the OECD.
- The MAD status has given global recognition to India’s non-clinical safety data by tremendously augmenting its credibility and acceptability across the globe.
- This has not only boosted the confidence of Indian GLP TFs but also led to removal of technical barriers to trade.
- The dedicated training of the inspectors and continued capacity building of Indian TFs in emerging areas by the ground team of NGCMA has resulted in upgrading Indian TFs to meet international standards.
(Source: PIB)
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