USFDA warnings: Concerns remain even as India fares better than US

Heightened regulatory scrutiny by the US drug regulator for Indian pharma is a concern for the industry. However, long-term data shows that Indian sites have received fewer warning letters from the US regulator, compared to China and the US itself.

Between 2014-15 and 2018-19 (FY19), sites in India received 66 warning letters from the US Food and Drug Administration (USFDA), while those in China received 73 warning letters, and plants in the US received 97 warning letters.

The data shared by Francis Godwin, director, office of manufacturing quality, office of compliance, USFDA, at an event here showed that India fared better than its neighbour China, even as it enjoyed a larger share of supplies of both formulations and bulk drugs to the US.

USFDA follows an October-September financial year. According to the USFDA, India accounted for nearly 18 per cent of the active pharmaceutical ingredients (APIs) sourced by the US, while China accounted for 13 per cent. The European Union (EU) had 26 per cent share, while US-based facilities accounted for 28 per cent.  

India accounted for 11 per cent of the finished dosage from manufacturing facilities that supply to the US, while China accounted for only 7 per cent, EU 18 per cent, and the rest of the world 13 per cent. India thus, has a high share when it comes to supplies to the US pharma market.

In 2019, Indian sites received 17 warning letters from the US, while China got 14 and US sites got 54 warning letters. The number of warning letters issued to US sites jumped from 19 in 2017-18 (FY18) to 54 in FY19. The total number of warning letters issued by the USFDA, however, grew only marginally —from 94 in FY18 to 98 in FY19.

Godwin said a majority of the sites in India (about 83 per cent) were found to be compliant with current good manufacturing practices. 

However, when compared to other countries, the compliance rate in India was ‘markedly’ lower, he added.

Sample this: In China, 90 per cent of the drug manufacturing facilities had acceptable final outcomes of inspections (i.e., no action indicated or voluntary action indicated certificates issued by the USFDA after inspection), while for India that is 83 per cent. India’s numbers look worse, compared to EU, which has 98 per cent compliance rate.

Most warning letters issued to Indian manufacturers have been around contamination, lack of established lab controls, data issues, equipment cleaning, and maintenance.

The USFDA’s foreign site inspections have increased from around 189 in 2003 to 966 in 2019. Godwin also highlighted that the time taken to issue warning letters (after inspection), too, has come down — from 11.6 months in 2015 to 6.5 months in 2019.

Godwin also highlighted that the time taken to issue warning letters (after inspection),too, has come down —from 11.6 months in 2015 to 6.5 months in 2019