The Narendra Modi government has announced another major initiative to help the biotech industry by formulating the revised guidelines for biosimilars that has become effective from August 15, 2016. The new biosimilars policy, called the "Guidelines on Similar Biologics" prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT), has been notified by DBT on August 18, 2016.
The Guidelines were prepared jointly by the members of a taskforce set up by CDSCO and sub-committee of the Review Committee on Genetic Manipulation (RCGM). The guidelines of 2012 were revised through a consultative process with various stakeholders led by members of ABLE (Association of Biotechnology Led Enterprises), other industry associations, leading scientific institutions and labs and through the public review process.
"Although case-by-case examination is important, these guidelines provide the required clarity and essentiality of data requirements for providing the similarity, physico-chemical characterization, preclinical structures and clinical trials," said Dr K VijayRaghavan, Secretary, Department of Biotechnology (DBT), Government of India.
How will the guidelines help the biotech industry?
"I expect to see a surge in Indian companies developing Biosimilars. This will lead to a large global opportunity along the lines of generic drugs where India can attain leadership," said an optimistic Dr Kiran Mazumdar Shaw, Honorary Chairperson of ABLE and CMD, Biocon. She has been a key member of the CDSCO task force that deliberated for over a year and finalized the guidelines at a meeting in New Delhi on 6th August 2016.