India received the international recognition to be a full adherent to Organisation for Economic Co-operation and Development (OECD) Council Act related to Mutual Acceptance of Data (MAD) in the Assessment of Chemicals. Thus India joins the part of chemicals programme related to MAD, with all of the rights and obligations of OECD member countries.This international recognition was long and eagerly awaited by industry and related ministries of the government. The full adherent status for India came after several cycles of rigorous evaluation processes by OECD followed by multiple discussion and coordination by OECD Council with the OECD member countries. A full adherent status requires a consensus among all the OECD countries difficult to obtain in any circumstances especially when it impacts health and environment of countries involved. For OECD to extend this invitation to India shows the confidence of the OECD council in the compliance monitoring system developed by India and satisfaction in the transparent procedures and processes for monitoring and complaint reddressal.
An Interactive Meet on India Receiving Full Adherent Status on Good Laboratory Practice (GLP) from OECD & Obligations GLP in Indian Scenario has been organized tomorrow. Union Minister for Science and Technology, Shri Pawan Kumar Bansal will deliver inaugural address. Keynote Address will be delivered by Dr. Girdhar J. Gyani, Secretary General, Quality Council of India (QCI) Need for Harmonization of Quality System in India.
The day-long meet will discuss on GLP in Agro Chemical Sector, Government Institution – Challenges, Herbal Sector, Agri Biotech, Road to GLP Full Adherent Status of OECD, CRO Perspective on GLP, Pharma Perspective on GLP, REACH & GLP- Legal Implications of GLP in Export of Chemicals, Industry viewpoints on REACH & GLP etc.
The major implication of India's full adherence to the MAD system is that non-clinical health and environment safety data generated in India under the conditions of 1981 and 1989 Council Act will be accepted by 33 OECD member countries (all EU countries, USA and Japan) and other adhering countries for purposes of assessment and other uses related to protection of man and environment.
Several Ministries and Departments of the Government of India have been keenly awaiting this development. These are Department of Agriculture & Co-operation, Department of Commerce, Department of Chemical and Fertilizers Department of Chemical and Petrochemicals and the Department of Pharmaceuticals. This major achievement for the country opens up newer avenues of employment generation in contract research for evaluation of chemicals; it removes a potential trade barrier since the REACH Regulation of EU now stipulates that all chemicals exported beyond 1 tonne would need to be tested in GLP environment.
The Government of India accepted the invitation of the OECD Council On 3rd March, 2011 to be a full adherent to OECD Council Act .The National GLP Compliance Monitoring Authority (NGCMA) was set up by a Cabinet decision and Gazette notification in August, 2002 under the Department of Science & Technology. The Government of India committed to adhere to the Organization for Economic co-operation and Development (OECD) principles of Good Laboratory Practices (GLP) for environmental and health monitoring of chemical substances. Since then, efforts have been made to develop robust monitoring procedures and national guidelines for nonclinical health and environment safety data of Pharmaceuticals, Agrochemicals, Industrial Chemicals, Cosmetics & food & feed additives.