The Centre for Advanced Research for Pre-clinical Toxicology at National Institute of Nutrition (NIN) has developed a common protocol for a multi-centric trial of Ayurvedic Bhasmas, having potential therapeutic use. The studies may be carried on this till 2007.

The Centre, set up in the year 2000, is also planning to undertake safety evaluation of nutraceuticals, designer foods and GM foods. Efforts are being made to obtain GLP accreditation from the National GLP Authority of Department of Science and Technology (DST) for the Centre, establish immuno-toxicology testing facility and strengthen the scientific component.

During the last six years the Centre has carried out safety evaluation of Chlorella for Indian Council of Medical Research; pre-clinical toxicity of Alpha Interferon for Shantha Biotech; pre-clinical toxicity of DNA- Anti Rabies Vaccine and Combination Rabies Vaccine under the National Jai Vigyan Science & Technology Mission for DBT, IISc and Indian Immunologicals Ltd; toxicity and allergenicity evaluation of recombinant hepatitis B vaccine for Indian Immunologicals; toxicological evaluation of coded ayurvedic formulations for CCRAS, Government of India, under WHO Biennium Programme. In the year 2005-06, the Centre conducted studies on the proprietary molecules of Issar Pharmaceuticals.

Dr B Sesikeran, director, NIN told Pharmabiz that NIN has multi-disciplinary infrastructure, which includes facilities like a large animal house with several species of small animals and a modern primate facility along with the expertise in disciplines such as pathology, pharmacology, biochemistry, veterinary medicine and statistics.

Indigenous Ayurvedic formulations, both pure herbal and herbo-mineral preparations also need to go through a process of safety evaluation, NIN's Centre has been working jointly with the Central Council for Research in Ayurveda and Siddha (CCRAS) in developing protocols and executing toxicology studies to generate data that would be internationally acceptable. A set of five reports on different herbal formulations has been developed and the herbo-mineral studies are in progress.

The Centre has prepared about 30 protocols for the pharmaceutical and traditional drugs industry and is carrying out study on safety and efficacy of an anti-cancer peptide for a company. The Centre will also carry out safety studies on malaria vaccine and participate in reverse pharmacological and toxicological studies on several indigenous drugs.

Safety evaluation has become mandatory for traditional drug preparations worldwide, including those of Ayurveda, Unani and Homeopathy. CCRAS has initiated the screening of several Ayurvedic products.