USFDA vigil on Indian pharma companies to become more stringent

Indian pharma companies, that are already grappling with regulatory compliance issues, will now have to be ready for more inspections as the USFDA has tied up with eight EU member states.

According to a report in The Economic Times, USFDA’s pact with Sweden, Austria, Croatia, France, Italy, Malta and Spain allows for recognition of each other's inspection outcomes and better use of expertise and resources by eliminating duplication.

Relying on inspections by EU regulators will allow USFDA to shift resources to other locations, USFDA told ET.

Indian Pharmaceutical Alliance secretary general DG Shah agreed inspections could be stepped up but termed it a long-term benefit, underscoring the positive outcome of a few recent inspections.

Barring Aurobindo Pharma, Zydus, Cadila and Divis Labs,that have seen comparatively better inspection outcomes, the likes of Sun Pharma, Dr Reddy's Laboratories (DRL), Lupin and Wockhardt are in lengthy remediation processes following warning letters and import restrictions.

Smaller companies like IPCA Labs, Emcure and USV, having exposure to the US markets, have also been slapped with a steady stream of adverse observations.

The USFDA observations have affected the pharma companies adversely with Sun slipping into losses in the first quarter while others like Lupin and DRL showed a wobbly trend with their market value nearly bottoming out in the medium term.

Indian companies account for around 30 percent (by volume) and about 10 percent (by value) of the USD 70-80 billion US generics market, according to a India Brand Equity Foundation report.