U.S. BIG PHARMA SEEKS TO BLOCK INDIAN COMPETITION THROUGH FDA

The 8 companies that have been served with Form 483 are Cipla, Torrent, Dr. Reddy's, Laurus, Eugia Pharma, Zydus, Alkem and Jubilant Generics. All sell their medicines in the US.

- ABHINANDAN MISHRA

In an effort at using the regulatory system to fight competition from Indian pharma companies, eight Indian pharma companies are amongst the 11 global companies that have been served with “Form 483” of United States Food and Drug Administration (USFDA) since the start of this year.

All these eight companies sell their medicines in the US. The eight companies who have been served with Form 483 this year are Cipla Limited (three times), Torrent Pharmaceuticals Limited (once), Dr. Reddy’s Laboratories Ltd CTO Unit 6 (once), Laurus Synthesis Pvt Ltd (once), Eugia Pharma (four times), Zydus Lifesciences Ltd (two times) and Alkem Laboratories Limited and Jubilant Generics (both once). The remaining three companies are from Japan, Iceland and China. In 2023, the USFDA had served this notice 20 times to different Indian companies. These companies are amongst the top manufacturers of drugs and medicines that are sold in India. Big Pharma is very influential in any US administration, which is why pharma prices in the US are often a hundred or more times more than equivalents produced by Indian companies.

The Form 483 notice, on the surface encourages pharma companies to significantly improve the quality standard on their production sites. In those cases where the motivation is not to battle competition, such moves also benefit the local markets and consumers in India by ensuring better quality drugs.

As per latest data, Indian pharma exports to the US climbed to $7.83 billion during the April-February period in 2024, from $6.8 billion in the same period in FY23. India’s total pharmaceutical exports increased by 9.34% at $25.04 billion from $22.9 billion during the period under review. The US contributes to about 30% of India’s total pharma exports.