Guidelines on “Similar Biologics: Regulatory requirements for Market Authorization in India” will be implemented from 15th September 2012.
The “Guidelines on Similar Biologics” prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic.
The guidelines address the regulatory pathway regarding manufacturing process and quality aspects for similar biologics.
These guidelines also address the pre-market regulatory requirements including comparability exercise for quality, preclinical and clinical studies and post market regulatory requirements for similar biologics.
For further details visit http://www.cdsco.nic.in/Bio%20Similar%20Guideline.pdf