India released "Guidelines on Similar Biologics"

India pavilion at 2012 BIO International Convention was inaugurated by Dr M K Bhan, Secretary, DBT on 19 June 2012 jointly organised by CII, ABLE and the Department of Biotechnology, Govt of India. All together 25 exhibitors representing different verticals of biotech industry participated at the India pavilion.
Dignitaries like Dr Kiran Mazumdar Shaw, CMD, Biocon Ltd, Mr. James C. Greenwood, President and CEO Biotechnology Industry Organization (BIO); Mr S Raghavan, Joint Secretary, DBT; Ms Anuradha Mitra, Joint Secretary and Financial Adviser, DBT ; Dr Madan Mohan, Adviser, DBT were present in the inaugural function.
On the sidelines of BIO2012, a press conference was organised to release the Guidelines on Similar Biologics.

• The guidelines were jointly prepared by Dept of Biotechnology, Ministry of Science and Technology and Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Government of India in consultation with industry and other key stakeholders.
• These guidelines provide insights into preclinical evaluation of those recombinant products that are claimed to be already approved biopharmaceutical products, referred as “ similar biologics” and therefore partly rely on the data from the already approved products for approving safety, purity, potency and effectiveness

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