ABOUT US

A number of countries require manufacturers of industrial chemicals, pharmaceuticals, veterinary drugs, pesticides, cosmetic products, food products, feed additives, etc., to establish through data that use of these products do not pose any hazards to human health and the environment. Non-hazardous nature needs to be established through studies and data, which will be examined by the regulatory authorities of the concerned countries. Good Laboratory Practice (GLP) is a system, which has been evolved by Organisation for Economic Co-operation and Development (OECD) used for achieving the above goals.

National GLP-compliance Monitoring Authority was established by the Department of Science & Technology, Government of India, with the approval of the Union Cabinet on April 24, 2002. Presently, India enjoys the status of a provisional member of the OECD for GLP. India is an Observer to the OECD’s Working Group on GLP and also a member of the OECD Test Guidelines Programme. Our aim would be to get the status of full membership in the near future so that the Indian industries do not have to get their test facility (products) certified from safety angle by other GLP monitoring authorities and do not lose on the trade front.

The National GLP Programme functions through an Apex Body, which has Secretaries of concerned Ministries/Departments, Director-General, CSIR and the Drugs Controller General of India as its members with Secretary-DST as its Chairman. This Apex Body is responsible to ensure that the National GLP Programme functions as per OECD norms and principles. The Apex Body is supported by Technical Committee on GLP, National Coordination Committee for OECD Test Guidelines Programme and Legislation Committee to enact a national legislation on GLP. The Authority has trained 33 experts in the country as GLP inspectors.

GLP-compliance certification is voluntary in nature. The test facilities/laboratories have to apply in the prescribed application form. After the application for GLP certification is received, a pre-inspection of the laboratory is carried out by the GLP inspectors, followed by a final inspection. The report, prepared by the inspection team, is put to the Technical Committee for recommendation to Chairman, National GLP- Compliance Monitoring Authority. GLP-compliance Certification is valid for a period of three years and the GLP Secretariat organizes annual surveillance and a re-assessment during third year for maintaining the certification.

Industries/test facilities/laboratories dealing with above chemicals and looking for approval from regulatory authorities before marketing them, may apply to the National GLP-compliance Monitoring Authority for obtaining GLP-compliance Certification for one or more of the following areas of expertise:

• physical-chemical testing
• toxicity studies
• mutagenicity studies
• environmental toxicity studies on aquatic and terrestrial organisms
• studies on behaviour in water, soil and air
• bio-accumulation, residue studies
• studies on effects on mesocosms and natural ecosystems
• analytical and clinical chemistry testing
• Others (please specify)