US authorities challenge India’s Sun Pharmaceuticals’ generic drug quality

January 24, 2023: Australia’s ABC News has reported that the US Food and Drug Administration has claimed that it found sub-standard production processes of generic medicines at Sun Pharmaceutical Industries’ production facility at Halol, Gujrat. The FDA does not accept the company’s response as adequate, and could block the entry of its products into the USA. The FDA wrote officially to Sun Pharmaceutical in December 2022, giving them 15 working days to respond.

This is part of a bigger picture of global competition for the pharmaceutical market, which is affecting universal access to quality medicines at affordable prices. The global market is structured by 20-year monopolies granted to patents under the World Trade Organisation’s Trade-Related Intellectual Property Rights (TRIPS) agreement.

India is the world leader in production of generic medicines, which contain the same active ingredients as the original version, and go on the market after the original patent has expired. India’s top pharma firms include Cipla, Aurobindo Pharma, Lupin, Dr Reddy’s Laboratories and Sun Pharmaceutical Industries.

The FDA expressed concern at any possible disruption to medicine supply as Sun Pharmaceutical responds to its demands, and will negotiate with the company if such a disruption is likely.

Its letter set out five significant failures leading to risks of contamination, including lack of appropriate equipment, cleaning standards and recording of batch checking against specification standards. 

The willingness of the FDA to negotiate indicates that the risk of contamination was not severe enough to justify the threat to lives of cutting off the supply of affordable medicines.

India’s generic manufacturers have been life-savers in the supply of low cost treatments for HIV / Aids and COVID-19 vaccines, and are seen as crucial in achieving the health-related sustainable development goal (SDG 3).

In August 2020, US President Trump issued an executive order that called for the gradual elimination of drug imports, both as active ingredients and formulations. France and Germany look to be heading in a similar direction.

The threat to India’s role as “Pharmacy to the World” makes the FDA action very sensitive, and the broader market dynamics are pushing India’s generic manufacturers to sell into middle-range countries with products with higher profit margins, and higher consumer prices.

Big Pharma in the West is notorious for putting profits before lives, and for gouging public funds for research and development of new drugs, which the firms then patent, enjoying TRIPS monopoly prices. But India’s generic firms are now also displaying the “too big to fail” characteristic.

Dinesh Thakur once headed research and development at India’s Ranbaxy Laboratories. He was the whistleblower in the ‘Ranbaxy case’ and is now a public health activist focused on improving the quality of affordable medicines.

He argues that the key problems identified in multiple FDA inspections over many years are the lack of cleanliness and sanitary conditions and fabrication of the data about the production processes. He notes that only Ranbaxy has ever been held to account, because of the corporate power of the big Indian generic companies. “It is all about profits, because quality comes at a price.”

The COVID pandemic showed the limitations of the current global patent and market systems, with most vaccines sold at high prices to high-income countries.  Vaccination rates in low-income countries are still only 26 per cent, and there is even less access to treatments and tests. Pharma company patent holders influenced rich country governments to block suspension of WTO patent rules during the pandemic. The challenge for the global trade and global health systems is how to ensure more equitable access to new medicines in pandemics and longer term access to quality generic medicines at affordable prices.