Regulatory Toxicology


Safety of human health and environment is the primary concern of the world and also the motto of this Institute. Generation of analytical and safety evaluation data on chemicals and products helps the regulatory agencies to take decisions for the production, marketing, transport, storage, categorization/labelling and usage of these chemicals/products used in day to day life that have an overriding influence on the sustainment and quality of our life and environment. In the pursuit of this goal, a state of the art facility for regulatory toxicology studies has been established and the existing facilities are being upgraded following the National/International guidelines to provide scientific knowledge for service to society, service to industry and sustainable development around the world.

In the fast developing industrial era, newer products viz. NCE (new chemical entities), genetically modified/engineered organisms, pesticides, finished or semi-finished products, crops and drugs, nano-materials, etc are being introduced in the market. As per the guidelines of the regulatory agencies, it is mandatory for the industries to have these finished products or raw materials evaluated for their cost benefit/ safety vs potentially hazardous ratio as many of these products or substances are liable to come in contact with humans and environment.

One of the major aims of the Regulatory toxicology is to assure the wellbeing of our populace by validating the product specifications and helping the regulatory agencies to take decisions for supporting the Indian industry in global positioning of their equally credible products. The expertise of scientific and technical personnel along with the data base on standard reference materials and model test substances, will serve as "Referral Centre" for other R&D institutions, industry, etc. venturing in designing, formulation, production and/or marketing their products. A whole new cadre of scientific and technical manpower in the country shall emerge from this effort because of unique analytical and biological approaches applicable to the safety evaluation of bio-technologically-derived products, gene-therapy, stem-cell therapy, nano-materials, etc. as against conventional toxicology for synthetic drugs and chemicals.

Compliance to Good Laboratory Practices (GLPs) is the key to international acceptance of safety data/reports on industrial and consumable products. Harmonized protocols and test procedures with compliance to Good Laboratory Practices (GLPs) improve mutual acceptance of data/reports and avoid technical barriers to the international trade. It eliminates the ground for expensive repetitions and expedites regulatory decisions which in-turn benefits both the society and the industry. Untiring efforts of the Regulatory Toxicology group in close coordination with the other groups in the institute have resulted in acquiring the GLP certification for selected studies at CSIR-IITR. At present GLP certification has been given in the field of acute and subacute oral/ dermal toxicity and genotoxicity studies and efforts are going on to widen the scope of studies under GLP. CSIR-IITR is the first CSIR laboratory and second in the Government Sector to achieve this distinction.

Mission and goals
Method development and analysis of xenobiotics in varied matrices. Safety evaluation of chemicals/ products following OECD guidelines.

Infrastructure facilities and expertise for the development of microextraction based sensitive analytical methods for xenobiotics in varied biological and environmental matrices. Safety evaluation of chemicals/ products using a battery of tests in rodent models under GLP.

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