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India launches 'similar biologics' guidelines at BIO2012

Source : India Education Diary
June 25, 2012

 

Date: 25th June 2012

Boston: 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.

Addressing the media Dr Maharaj K Bhan, Secretary, Department of Biotechnology, Government of India said "it was path-breaking development to bring clarity on the subject and lay out a clear regulatory pathway for manufacturers of similar biologics". 

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.

Life Science India - a bi-monthly magazine a mega initiative of Confederation of Indian industry in the life science sector was launched during the inaugural of India pavilion at BIO2012. it is estimated that the magazine reache more than 150, 000 global readers including close to 10,000 eminent individuals, who drive the sector in India.

Second Bilateral Meeting of Indo-US Life Sciences Industries: Biotech Innovation in India was also organised in the sidelines of BIO2012, to discuss on topic like Upstream Research Collaborations, Regulations for Biological Products/ Biosimilars, IP Issues in India and Their Impact on Biotech. The meeting was Co-chaired by Dr. Kiran Mazumdar Shaw, Chairman & MD, Biocon Ms Christine Bugos, Institutional Relations and Policy, EMD Serono. The meeting was attended by prominent industry member from both the countries.

 
 
 
 
 

 


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