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.
Good Laboratory Practice (GLP) is a quality system, which has been evolved by Organisation for Economic Co-operation and Development (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.
The Department of Science and Technology (DST), Government of India, 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.
The non-hazardous nature of chemicals needs to be established through studies and data, which is examined by the regulators of the concerned countries to certify that the use of these chemicals does not pose any hazards to human health and the environment.
On March 3, 2011, India became 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. 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.
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.
Prof. Ashutosh Sharma, Chairman-GLP Authority & Secretary, DST commented, “India’s leadership in GLP brings a greater recognition of our certification of quality for global businesses. This is also a link in the chain to Atamnirbharta, which is to have structures and processes that are adhered to global standards.”
The OECD has acknowledged the contribution of the Indian GLP program and designated Dr. Ekta Kapoor, Scientist E, NGCMA, DST, as the Vice-Chair of the OECD Working Group on GLP for 2021 and 2022. With continued Government commitment and emphasis on further capacity building on GLP in the country, India is destined to be a global leader.