Huge scope for Indian pharma as FDA eases drug scrutiny over shortage in US

Injectibles account for 60% of crunch; most plants under American regulator's lens the past two months have now received positive outcomes

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.
 

Drug shortages have remained high this year in the US and the CLSA noted that the issue seems to be exacerbated when it comes to injectable products, which account for over 60 per cent of the current drug shortages. India accounts for roughly 30 per cent of the generic drug supply to the US and it is a great opportunity for the players here.

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.
 

Following these, some brokerages upgraded the Lupin stock to ‘buy’ from ‘reduce’. Analysts see the combination of Indian plants clearing USFDA scrutiny and the growing drug shortages in the US as positive signs for exporters here.

CLSA analyst Arun Dalal noted that fewer warning letters, partly aided by fewer inspections, are nonetheless positive.

Kedar Upadhye, global chief financial officer (CFO) at Cipla, said wherever it sees any demand uptick, the company will attempt to supply. Industry insiders said the current drug shortages could be only a short to medium term opportunity as such, but the EIRs will go a long way to boost overall exports.

Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance (IPA), felt that the pharma sector has worked on improving compliance and the string of EIRs is a testimony to that.

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.”