The drug regulator had earlier made it mandatory that no person could be employed in any pharmaceutical/bio pharmaceutical manufacturing unit unless they had a formal diploma or degree. Photo: BloombergNew Delhi: The drug regulator’s proposal to make it mandatory for all employees in pharmaceutical manufacturing facilities to get a skill certification by January next year has triggered concerns in the drugs industry. Worried about the potential losses and the litigation that the proposal could invite, industry experts, during a meeting with officials in the Drug Controller General of India (DCGI), have asked for a year’s more time for certification of all employees. The move came after domestic pharma companies faced action from regulatory authorities in the US and Europe due to the quality of products, poor manufacturing facilities and improper documentation. With the deadline looming, the industry has now approached Drug Controller General of India calling for more time.

Source: Mint October 22, 2017 19:06 UTC