USFDA resumes inspection of manufacturing plants in India

The United States Food And Drug Administration (USFDA) resumed inspections in India last month, said Christopher Middendorf who is with the USFDA’s India office.

Protocols have been put in place to protect all those involved in the physical inspection of manufacturing sites, and the feasibility of alternative methods is being reviewed, said Middendorf, responding to a query at the Indian Pharmaceutical Forum (2021). The inspections would be as defined in their “mission critical” that looked at Covid-19 therapies or shortages of other pre-approved drugs, he indicated.

Restarting inspections assume significance as it paves the way for Indian drug companies to get approvals to sell their products in the US. This, in turn, benefits the US as well, as it faces shortages on certain products.

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India has 665 USFDA-approved manufacturing plants outside the US, the highest in the world. Inspections had stopped early last yeardue to the pandemic. In fact, several plants are also in different stages of redressal, following earlier observations made by the USFDA.

Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance (IPA), said they have been in constant dialogue with the US regulatory authority with an eye on product availability. More meetings are being planned to get inspections going in the coming months, he said. Other foreign regulators have been undertaking virtual inspections, albeit in a limited way. The IPA is a platform of the large domestic drugmakers.

Pointing to the disruption due the pandemic, Dr Michael Kopcha, USFDA’s Director Office of Pharmaceutical Quality, pointed out that disruption was “the perfect time for innovation”. Citing a consumer study done about a couple of years ago, Kopcha saidthe widely-held perception that emerged from this study was that companies outside the US (but selling in the country) did not adhere to good manufacturing standards. A section of the survey respondents had faced supply shortages and had price issues as well. In 2021, while everyone was focussed on getting back to normal, he urged the pharmaceutical industry to return “to a better normal” by thinking differently and addressing concerns raised by consumers.