A senior official in the US Food and Drug Administration (USFDA) office in India has emphasised the importance of effective and timely communication from pharma companies in their engagement with the health regulator.
Companies that had been issued Form 483, post an USFDA inspection, have to respond within 15 days. They can seek more time to fix the issues, engage a consultant, but all of that they have to convey to the agency within the deadline.
They need to provide more information and communicate more as that’s always helpful, Deputy Country Director Sarah E. McMullen said, adding the pharma companies in India over the years had matured with their regard to quality systems. On its part, the USFDA is engaging with the Central Drugs Standard Control Organisation (CDSCO) and Gujarat, Telangana, Maharashtra, Andhra Pradesh and Karnataka that host the most FDA registered pharmaceutical facilities in the country.
Ms. McMullen, who spoke to media, on the sidelines of a panel discussion at the BioAsia 2020 Conclave here on Wednesday, said the number of inspections of pharma units in India by USFDA was pretty consistent. A little over 200 pharmaceutical inspections were carried out by the regulator in the country in a year, she said.
The USFDA issues a Form 483 post inspection in the event of the inspectors observing any conditions that may constitute violations of the norms. The responses of the company, to how it is planning to address the issue, should be comprehensive, thoughtful and realistic, she said.
