India released the draft regulatory guidelines for ‘Similar Biologics’ at the BIO industry conference in Boston, USA, on 19 June 2012. These guidelines were revised in 2016. Under these guidelines Central Drugs Standard Control Organization (CDSCO) is responsible for laying down standards for the drugs, to ensure that the requirements regarding the manufacturing process and quality are met, providing approvals for clinical trials, granting marketing rights, granting import or export licenses and ensuring pre-market and post-market regulatory requirements for biologics.
