Unlike the US and Europe, India does not currently have a tracking system for the drug supply chain.
The central drug standards authority has issued a notice to revisit the Drugs and Cosmetics Act and Rules, reports Ashmit Kumar.
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.
Joint inspections with eight other regulators carried at six of Ranbaxy‘s laboratories in Himachal Pradesh found discrepancies in testing, stability standards and expiry dates, among other standards.