Pre-Clinical Toxicology Centre

Pre-Clinical Toxicology

Objectives of the Division

  1. To evaluate the preclinical safety and efficacy of innovative bio-pharmaceuticals (recombinants), GMOS , Stem cell therapy, Nano-Medicine, traditional preparation as per national / international guidelines.

  2. To evolve the procedures   to determine the preclinical safety profile for the products which are new and facilitate regulators to develop guideline  in the country.


Since its establishment in 1999 the centre has screened recombinant products (viz. rDNA Anti rabies vaccine, interferon, tetravalent vaccine , HPV oral vaccine), peptides which were developed indigenously for the first time, traditional preparations like Bhasmas (herbo-mineral preparations, auyrvedic formulations), food additives etc. Approximately 80%of the reported products are in clinical trails and few are in clinical use.

In the recent past, the safety profile of another innovative therapy by Stem cells has  also been completed.

After being supported by ICMR, initially for a period of five years, the center has grown and is self sufficient. The centre has developed collaboration with intra/inter  governmental  as well as private agencies under the Public Private Partnership (PPP)  programme. The Department of Science and Technology (DST), Governemnt of India, has identified the potential of this centre and supported with a grant to make it a centre of excellence in Good Lab Practices (GLP) standards and to carry out safety, efficacy evaluation of new molecules.

The centre has not only contributed in evolving the guidelines but also generated financial resources and developed human resources who are now employed in industry and other research organizations.

Present Research Activities

In current year the bio-safety specially preclinical toxicity / allergencity of genetically modified foods ( bt brinjal, bt. Okra), and crops like bt. Cotton are being carried out. The appropriate animal models in assessing the efficacy, anti-inflammatory, anti-atherosclerotic, anti diabetic, anti obesity, immune modulatory profile, is being undertaken.

Thrust areas for future

Establishing pre-clinical evaluations in transgenic animals are essential in view of new category of products.

Strengthening the reverse pharmacology base for rapid screening and validation of traditional preparations and foods having therapeutic potential. This approach would be an essential part of translational research.

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