In a trend that could augur well for the Indian pharma industry, inspections of manufacturing sites by the US Food and Drug Administration (USFDA) have gained pace.
“In the last four months, there has been a perceptible spurt in the number of inspections, and the agency has also hastened the process of post-inspection procedures,’’ a senior director with a Hyderabad-based listed drug major told businessline.
This is evident from the number of Establishment Inspections Reports (EIRs) being received by pharmaceutical manufacturers of late. About a dozen Indian drug-makers, including Aurobindo Pharma, Lupin, Alembic, Laurus Labs, and Natco Pharma, have received EIRs from the USFDA in recent months.
According to industry sources, few major drug makers have been investing in setting up new facilities in the post-pandemic phase, which are in various stages of completion. Speedy inspections would also augur well for the new facilities.
India has about 670 USFDA-approved manufacturing facilities in India, the highest outside the US. After a break due to Covid, FDA resumed its inspections on a low scale early 2021.
“The feedback from our members point out to an increased traction in the inspections which is a welcome development. We hope this would reach the pre-pandemic levels soon,’’ said R Uday Bhaskar, Director General, Pharmaceuticals Export Promotion Council (Pharmexcil).
The increased pace of inspections by the US regulator is seen as a greater push to the Indian pharma industry, as it will lead to more product filings for approval and, thereby, higher exports.
The US market has a lion’s share of about 32 per cent in the total drug exports of the country. And they are increasing. In the April-May period of FY24, exports to the US grew by 10.4 per cent at $1376 million compared to $1245 million same period last year, according to Pharmexcil data.