Most Indian pharma plants that were inspected by the US drug regulator in the last few months or so have received positive outcomes.
As drug majors in the country have gradually improved compliance, against the backdrop of high shortages in the US, analysts see this as a positive sign for pharma exports.
If one looks at the inspection outcomes for plants between March and May, most have received Establishment Inspection Reports (EIRs) from the US Food and Drug Administration (USFDA). For example, Lupin’s active pharmaceutical ingredient (API) unit in Vizag got an EIR in mid-May.
The facility was inspected by the USFDA in January this year. Earlier, Lupin’s Pithampur plant -I and Nagpur plants (both formulation making units) had received EIRs in April.
Meanwhile, given the transportation and logistical issues during the pandemic, the USFDA, too, is looking at alternative inspection tools and approaches. In a recent statement, it noted, “During Covid-19, the US Food and Drug Administration will continue to utilise and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections.” It said while the pandemic has added new complexities to its normal operations, it implemented alternative approaches with onsite surveillance inspections.
Jain, however, does not see any slack in scrutiny by the agency. He said the US regulatory authority has enough checks and balances in place to ensure that quality paramaters are maintained across the globe.
The FDA noted, “Based on decades of experience with our diverse regulated industries, we believe most FDA-regulated firms understand and appreciate their responsibility to ensure the safety of the products they manufacture or produce....Most firms strive to reliably provide quality products and maintain the integrity of the supply chain.”