India is committed to a robust and transparent quality system in the critical area impacting human health and environment. Addressing an interactive meet on "India receiving Full Adherence Status on Good Lab Practice (GLP) from the Organization of Economic Cooperation and Development (OECD) Council, Shri Pawn Kumar Bansal, Minister of Science and Technology, Earth Sciences and Parliamentary Affairs said here today that high standards maintained by Indian Test Facilities in terms of infrastructure, conduct of tests, reliability of results and robustness of internal audit systems already helped to obtain and retain GLP certificates from OECD countries such as Germany, Netherlands, Belgium and Switzerland for more than two decades. Congratulating all those involved in achieving the OECD GLP full adherent status, the Minister emphasized that with this recognition comes a very great responsibility for the industry, the monitoring authority and the inspectors who play a critical role in on site monitoring. It is now imperative to build a strong GLP base in India by increasing the number of GLP certified test facilities. Presently, there is only one Government organization, viz NIPER, Mohali that has got a GLP certificate. There is, therefore need to enthuse and empower select Government institutions to come up to the standards of OECD GLP in order to encourage Indian trade in the sectors of Chemicals, Paints, Bio-tech & Food and allied areas.
Referring to open market economy and WTO regime, the Minister said India has opportunity to increase its size of exports, provided we conform to global quality standards to eliminate any technical barriers under the WTO regime. Indian Pharmaceutical products, pesticides products and industrial chemicals, veterinary drugs, medical equipments, food and feed additives have witnessed a substantial growth in exports in the last five years. Compliance with the OECD Principles of Good Laboratory Practices (GLP) will assure the regulatory bodies of the quality & integrity of data generated by the laboratories or Test Facilities.
With this recognition, data generated in GLP certified Indian Test Facilities, which is required for registration or licensing, will be acceptable in all 33 OECD member and adherent countries. This will help Indian industries save the expenses for getting their tested data generated outside the country in GLP compliant test facilities. Indian Test facilities will also save the expense of hosting multiple foreign inspection teams. Further, this will generate a large volume of work which would come to Indian GLP certified Test facilities.
India presently has 18 GLP certified facilities out of which six are pharma/agrochemical companies; eleven, contract research organizations and one, a government lab .This year we have seen an enhanced interest by institutions in getting a GLP certificate from the NGCMA and 10 new applications have been received from different parts of the country.
“To promote the export of Indian Food & Herbal products, the pesticide residue contents would have to be analyzed according to protocols of OECD GLP. For this, creation of GLP testing facilities in the food parks will be required. EU has now also come up with the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislation which necessitates GLP testing of chemicals exported to EU countries. Another recent legislation of EU mandates testing of all herbal products exported to EU in a GLP environment. GLP has to now move from an ad hoc concept to a legally enforceable code, designed to control and regulate the quality of laboratory-based operations. The Government plans to bring a suitable legislation on GLP, once a consensus amongst the various Ministries involved is worked out,” Shri Pawn Kumar added.
The full adherent status for India has been possible after several rounds of rigorous evaluation processes by OECD followed by multiple discussion and coordination by OECD Council with the OECD member countries. This development demonstrates the confidence of the OECD council in India’s compliance monitoring system and the transparent procedures and processes for monitoring and complaint redressal. The National GLP Compliance Monitoring Authority (NGCMA) was set up in 2002 through an act of Parliament to adopt OECD Principles of Good Laboratory Practices and Compliance Monitoring to ensure Mutual Acceptance of Data by the OECD Nations. Application of GLP principles & compliance monitoring assures quality and integrity of test data generated by Test Facilities and labs. Industries exporting products which require registration or licensing from regulatory authorities before marketing will be benefited greatly by GLP certification which will also eliminate technical barriers to trade.