It's a step towards ensuring entry of cheaper biotech drugs into India. The government has finally, after two years of intense engagement, prepared the formal regulatory guidelines for marketing generic versions of biotech drugs called 'similar biologics,' reports Archana Shukla of CNBC-TV18.
While standardised guidelines for marketing synthetic drugs have been in place for a while now, the Indian government is finally ready with a similar set for approving generic biotech drugs as well.
In a 42-page document titled 'Guidelines for Similar Biologics', the two regulators - Department of Biotechnology and the Central Drugs Standard Control Organisation has listed a host of provisions from pre-marketing approval to quality comparisons and post marketing surveillance for generic biotech drugs.
Formulated on similar lines as MEA of Europe, the new guidelines mandates a biosimilar can be developed only against an authorised reference biologic drug if reference biologic not