Indian pharma industry in doldrums? US FDA reports contamination in factories

Following a string of deadly manufacturing mishaps, the world’s biggest supplier of cheap medicine has come under heightened scrutiny. US inspectors have recently discovered extensive problems at plants controlled by some of India’s largest pharmaceutical companies. The US Food and Drug Administration, which is expanding visits to Indian manufacturers, has sent warning letters and alerts to dozens of drugmakers. 

The US Food and Drug Administration, which increased visits to Indian facilities after the relaxation of Covid-19 constraints last year, has sent alerts and warning letters to dozens of drugmakers. Inspectors described filthy working conditions at production facilities, poorly trained employees, torn paper, unattended customer complaints, and proof that defective pharmaceuticals were being exported to the US.

The extensive failures, documented in FDA papers obtained by Bloomberg News under the Freedom of Information Act, imply that flaws were overlooked in some Indian facilities that export to the US because factory audits were suspended for nearly two years during the pandemic.  

The US and several other nations receive the majority of their generic medication from the South Asian country. The $50 billion industry is in the news following a slew of scandals involving smaller, privately held Indian firms, including the adulteration of cough syrup that killed scores of children in the Gambia and Uzbekistan and the export of tainted chemotherapy medications to the US.

Reiterating their recommendations for more regulation and a global reevaluation of supply chains in response to these deaths are public health activists. In addition to pushing for more American drugs production, the Biden administration has issued warnings over the overwhelming importation of pharmaceuticals from nations like India. The fatalities and medicine recalls also occur at a crucial moment for Prime Minister Narendra Modi’s administration, which is promoting the South Asian country to investors as a competitive alternative to China for high-quality manufacturing. 

“It’s like playing whack-a-mole,” Alice Wang, a London-based fund manager at Quaero Capital LLP, which for now has avoided investing in Indian pharma firms told Bloomberg. 

“India is still behind China in many significant ways and some investments in the high-value-precision manufacturing spaces may end up needing a reality check,” she added.

Several warnings given

The FDA has been warning about factory standards in India for a long time. In 2019, the organisation informed Congress that, among the nations it oversaw, India had the lowest proportion of inspection results that were deemed acceptable at drug manufacturing facilities (83 per cent). The US came in second with a percentage of 93 per cent, followed by China with a percentage of 90 per cent, and the European Union with a percentage of 98 per cent. A more thorough analysis was not included in the study.

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