New guidelines to cut approval time of biosimilars in half

In a move that could benefit companies like Biocon, DRL and Zydus Cadila, India's drug regulator Central Drugs Standard Control Organization (CDSCO) is set to launch revised guidelines for biosimilars over the next three to four weeks.

Priya Sheth of CNBC-TV18 reports that the regulator plans to categorically outline aspect of post-marketing safety of drugs. These new regulations may cut approval timeline by more than half for biosimilars.

The government is trying to balance patient safety along with the timely entry of drugs in market with these new guidelines, she said.Watch video for more...