USFDA to conduct more surprise checks of pharma factories in India

“A mixture of announced and unannounced inspections is important, and you will see more unannounced inspections,” FDA Commissioner Robert Califf said in an interview to a TV news channel.

He also said a bottom-up approach was important with the staff having deep integrity and honesty even if that hurts.

The number of inspections carried out by the FDA of Indian pharma units had come down during the Covid-19 pandemic.

However, there has been an increase in these inspections since July this year after the FDA faced criticism from a US House committee entrusted with overseeing its regulatory activities in India and China.

The recent incident of eyedrops manufactured by a Tamil Nadu company turning out to be harmful for some users in the US had also triggered serious concern over quality.

Califf said that he expected India to continue being a dominant supplier to the US, the world's largest market for medicines.

He said that established Indian companies which have been working closely with the FDA have come up to global standards, but the new entrants should be trained with regard to all aspects of the industry.

The US accounts for a one-third share of India’s total drug exports and is a growing market.

In the April-May this year, exports to the US grew by 10.4 per cent at $1,376 million from $1,245 million same period last year, according to Pharmexcil data