USFDA approvals for Indian firms halve in 2021

The pace of approvals for abbreviated new drug applications (ANDAS) by the US drug regulator has halved, compared to precovid levels, revealed the latest data from India Ratings & Research (Ind-ra).

Compared to 670 global ANDA approvals given by the US Food and Drug Administration (USFDA) in the first half (H1) of calendar year 2019, the number of approvals has halved to 328 in H12021 (calendar).

Within this, the ANDA approvals secured by Indian pharmaceutical (pharma) firms have fallen from 267 in H12019 (calendar) to 137 in H12021 (calendar) - a 49-per cent drop.

India’s share in the global ANDA approvals has, however, remained stable at around 40-42 per cent.

Physical facility inspections were not undertaken, and prioritisation of product approvals was based on requirement, pointed out analysts at Ind-ra. They added that there were fewer fresh approvals than the pre- Covid levels witnessed by Indian companies in H12021 (calendar).

“Due to lack of new approvals, Indian companies tried to push the existing basket of products, leading to a downward trend in pricing,” said analysts.

The first quarter of 2021-22 has seen strong price erosion in the US market. Most Indian pharma majors have posted both a year-on-year and a sequential dip in US revenue.

Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance representing big pharma players in India admitted to USFDA audits having gone down during the pandemic.

The industry concurs. “In the past one and a half years, there have been some delays in USFDA approvals, especially those related to facility inspections. Many agencies from other countries (regulators), which did not insist on facility inspections, did virtual audits or went with the earlier audit results. The approvals have, in fact, come down during the pandemic,” said Arun Chandavarkar, managing director, Biocon Biologics.

He also clarified that there is indeed some talk of the USFDA starting virtual audits, but those could possibly start first within the US (domestic plants).

Indian audits are likely to pick up in the coming months. Vinita Gupta, chief executive officer of Lupin, said the India office of the USFDA is likely to resume site inspections soon.