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USFDA: Manufacturers’ Quality Systems In India Have Matured

HYDERABAD: The US drug regulator, United States Food & Drug Administration (USFDA), indicated that the overall adherence to quality framework by Indian manufacturers has improved over the last couple of years.

“I think that if you are talking about difference from a few years ago, there has been an increase in maturity of quality systems…,” Dr Sarah McMullen, deputy director, USFDA India office, said on sidelines of BioAsia 2020 when asked about the performance of Indian firms.

McMullen added that FDA has been closely collaborating with the Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) and in many inspections, CDSCO officials join as observers. FDA conducted around 200 inspections last year in India, which supplies approximately 40% of the generics sold in the US.

The FDA official said that once pharma manufacturing units receive Form 483, they must respond to authority in “comprehensive thoughtful and realistic” manner within the stipulated time of 15 days, following which they can fix the problem.

“So, if you are facing regulatory action, you need to be open and transparent in your communication to the agency … your responses are read comprehensively by the agency…you have to make a response within 15 days to 483, you do not have to fix everything in 15 days. So, I think that is a misconception… so sometimes people want to look at short-term fix or something and that might not be the most appropriate thing …,” she said while participating in a panel discussion on ‘Meeting the Quality Imperative’.- Times Of India