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 authorised in India, it should have been sold for at least four years with safety and efficacy data.
Guidelines also set standards for highly consistent manufacturing processes. However, the provisions will not apply to biosimilars already launched in the market.
Until now, the Review Committee on Genetic Manipulation used to approve these similar biologics on a case to case basis but now these guidelines will set a standard approval pathway.
The biosimilar market in India already has big players like Wockhardt, Reliance Lifesciences, & Biocon while others like Cipla, Lupin and global players like Merck and Roche are all hoping to enter.
Initial comments from the industry have been restricted as the guidelines, which was unveiled in an international pharma are yet to be formally released in India. However, experts say that issuing formal regulatory guidelines does put India on a stronger platform to stake a bigger claim to the emerging USD 3 billion biosimilar medicines