The Pune-based independent toxicological contract research organisation (CRO), Intox has recently received a GLP (Good Laboratory Practice) certification from The Netherlands GLP Compliance Monitoring Programme, Food and Consumer Product Safety Authority Government of The Netherlands.
The GLP certification to Intox will prove to be a boon to Indian pharmaceutical and chemical/agro-chemical industries which are in desperate need for a toxicological laboratory offering affordable GLP compliant research and testing services within India, but with worldwide acceptability, so as to enable their products to get registered with marketing permission in regulated world markets.
Besides, in the face of the new European regulation 'REACH' (Registration, Evaluation, Authorisation and Restriction of Chemical Substances), enforced since June 2007, which would prevent export of chemicals to European markets if toxicity data generated in a GLP certified laboratory is not submitted, Intox's certification now offers a platform in India to generate such toxicity data.
Toxicological studies not only comprise of about 10-15 per cent of the total cost of new drug development, but they play a pivotal role in selection of a drug candidate. Elaborate toxicity studies are also required to be conducted before new pesticides and other potentially hazardous substances can be released for their intended use. Only that data which is generated in GLP certified laboratories is acceptable to the regulators. Inadequate availability of GLP certified CROs in India had compelled several Indian companies to outsource toxicity studies in European/US laboratories where costs have been prohibitively high.
This certification, which confirms that Intox Pvt. Ltd. is currently operating in compliance with the OECD Principles of Good laboratory Practice (GLP), follows similar certification of Intox by the National GLP Monitoring Authority, Department of Science and Technology, Government of India, earlier this year. The certifications have been offered to Intox, after rigorous inspections of its facilities and systems, for its operations in areas of its expertise in toxicity studies, mutagenicity studies, environmental toxicity studies on aquatic and terrestrial organisms, and clinical chemistry testing.
"Amongst three other Indian CROs which have been GLP certified by an OECD member country, Intox has been a unique example of an independent venture founded by scientists, without any external support and funding. This feat of procuring two GLP certifications in one year has been a culmination of years of hard work and dedication to highest standards of research by the staff of Intox," said .Dr. Prabhakar Y. Naik and Dr. Mukul P. Pore, who co-founded Intox Pvt. Ltd. in 1995.