'Shared Best Practices And Protocols': US FDA Trains Officers in India with Inspection Expertise for Drug Manufacturing Units

To introduce a deeper understanding of inspection processes conducted by the United States drug regulator, the US FDA has launched a programme inviting inspectors from four Indian states to shadow its inspectors during checks, News18 has learnt.

One of the world’s strictest health regulators, the United States Food and Drug Administration has sensitised Gujarat, Telangana, Goa, and Karnataka to the FDA’s inspection process. And now, officers from these states are eligible for inclusion as “observers” in other inspections.

In a letter written by Sarah McMullen, country director, FDA India office, she has “appreciated” the Indian drug regulatory agency Central Drugs Standard Control Organisation of India (CDSCO) for “cooperation and engagement on matters of mutual interest including the observed inspection program”.

McMullen wrote the letter to the Drugs Controller General of India – chief of CDSCO – on March 21.

News18 has accessed the letter in which McMullen described the FDA’s initiative to work with states to teach the FDA’s inspection protocol. “FDA recognizes the importance of inspections and is mindful of the enforcement authorities by both central and state regulators,” she said.

The US agency has worked with several Indian states where there are high numbers of FDA-registered facilities, the letter said. It added that “FDA has shared best practices and inspectional protocols in regulatory forums with several states”.

While listing Gujarat, Telangana, Goa, and Karnataka, the letter said these states have been sensitised to the FDA’s inspection process. Also, it said, they are eligible for inclusion as “observers” for relevant inspections in their respective states.

“We would appreciate relevant opportunities being made available to state inspectors to attend as observers as practical,” McMullen said while thanking the regulator for collaborations.

According to a senior government official, these “observers” will go for inspections with the team of inspectors but they will be silent spectators.

“The observers will not be the signatories or won’t interfere in the inspection process. The objective of the FDA was to teach Indian inspectors the way the US FDA inspects drug manufacturing units. It will help Indian officials understand and prepare for their inspections in a better way,” said the official.