India achieved full adherent status on Good Laboratory Practices (GLP) certified by Organization of Economic Co-operation and Development (OECD) on 3rd March 2011. This has come after the Government accepted the invitation of OECD Council to become full adherent to OECD Council Act related to Mutual Acceptance of Data (MAD) in assessment of chemicals and to join that part of chemicals programme related to Mutual Acceptance of Data, with all of the rights and obligations of OECD member countries.
As a result of India achieving full adherent status on GLP, the result of non-clinical chemical safety testing done by Indian test facilities will be accepted in all OECD member countries. India labs certified by the National GLP Compliance Monitoring Authority would not be required to be evaluated by foreign inspectors. The Indian manufacturers would be able to get their products tested in GLP certified Indian test facilities.
The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers is in the process of selecting a Consultant to assess the existing GLP compliant facilities vis-à-vis requirement of Pharma industry, gaps if any, and drawing up schemes for establishment/upgrading the existing testing facilities so as to make them GLP Compliant Labs. The Department of Science and Technology has put in place enabling mechanisms to encourage the test facilities in both Government and Private sector to come up to the standards of GLP including sensitizing programmes, training programmes for test facilities, quality assurance personnel and study directors to inculcate a GLP environment in the country and encourage test facilities to apply for a GLP Certification from the National GLP Compliance Monitoring Authority, Government of India.
The Minister of State for Science and Technology and Earth Sciences, Shri Ashwanikumar gave this information in a written reply to a question by Sh A Elavarasan in Rajya Sabha today.