Last week media outlets reported allegations by P V Appaji , DG of the Pharmaceuticals Export Promotion Council (Pharmexcil), that the US Food and Drug Administration (FDA) has stopped letting Indian regulators know when it comes to inspect drug and ingredient plants.
Dr Appaji linked the increase in Form 483 observations at Indian firms to a change in how US regulators interact with their Indian counterparts, telling Live Mint “the earlier practice was that whenever they [US FDA] are visiting any Indian site they used to inform us. Now, they started coming without any notice.
He told the publication the change was important because “cultural differences and body language may sometime widen the gap (during FDA inspection)” adding that Pharmexcil has asked the US agency to “allow Indian regulators also to be present during the inspections.”
We asked Dr Appaji for more details, however he did not respond to a request for comment.
The allegations are in keeping with opinions expressed by Dilip Shah, secretary general of the Indian Pharmaceutical Alliance (IP), who said because the majority of US FDA inspectors are based outside the country they “do not know Indian culture.”
When in-Pharmatechnologist.com put Dr Appaji’s comments to a US FDA spokesman he rejected the suggestion there had been a change in policy.
“FDA continues to discuss with our regulatory counterparts in India specific terms for collaborating on each other’s inspections, and on informing our respective regulatory authorities before undertaking inspections, so that host-country inspectors may join inspections as observers.”
The spokesman also pointed to the statement of intent signed by US FDA Commissioner Margaret Hamburg and Ministry of Health & Family Welfare (MoH&FW) Secretary Keshav Desiraju last February as evidence there had not been a policy change.
The document, signed during Hamburg’s visit to India last year, specifies that each agency engages as “observers in medical and cosmetic product and inspections conducted by the other participant as per specific terms to be agreed and as time and resources allow.”
It also states that: “Informing the respective regulatory authorities before undertaking inspections, so that host-country inspectors may join inspections as observers” should be standard practice.
After the article was published Dr Appaji contacted in-Pharmatechnologist and restated that: "In the past, FDA officials used to inform our member companies in a advance a few days before. It was perhaps to ensure availability of senior management at the site.
"However, since last about two or three years visits are made without any advance info. This is well appreciated by our members. We understand from reliable sources that Indian Govt has suggested to USFDA that if Indian regulatory staff is accompanied with US FDA regulators, it would help regulators to understand the requirements . We have no idea of latest position."