Gambia Tragedy Imperils India's Drug Efforts

 

"The deaths of over 60 children in Gambia, which may be linked to cough syrup made in India, has put an unwelcome spotlight on India's enormous generic-drug industry, a key global exporter and a significant source of drugs for American pharmacies.

The World Health Organization last week issued an alert on four pediatric cold and cough syrups purportedly manufactured by a little-known, privately held Indian company -- Maiden Pharmaceuticals. The WHO found that the medicines had unsafe levels of diethylene glycol and ethylene glycol, and said the medicines may be linked to acute kidney injuries and deaths. Maiden didn't respond to requests for comment by phone and email.

India's drug regulatory agency has also launched an investigation. This isn't the first such tragedy: In 2020, over 10 children died in Jammu and Kashmir after consuming syrup with high levels of diethylene glycol from a different company. This latest incident risks scuttling India's chance to cement its position against China -- also a major drug supplier -- as Western skepticism of China has been growing.

India exported drugs worth $24.35 billion in the financial year ended in March 2021, according to the nation's Department of Pharmaceuticals. India controls a full 20% of the global generic-medicines market and has the highest number of U.S. Food and Drug Administration compliant pharma plants outside of the U.S., according to the Indian government.

Key to the nation's success has been quality at low cost. India produces drugs at around one-third of U.S. production costs, according to a 2020 Deloitte report. One factor is policies that allowed Indian companies to reverse engineer drugs without paying royalties to original patent holders, infuriating Western pharma giants. Affordable HIV treatments from India are one of the greatest success stories in medicine. Over the past decade, however, the FDA has increasingly highlighted issues with quality control.

Nonetheless, in 2020 opportunity knocked: When China locked down Hubei province, critical drug deliveries were delayed. Narendra Modi's administration recognized the chance to establish India as an end-to-end pharmaceutical supply location and move upstream into active pharmaceutical ingredients, or APIs -- the chemical compounds in drugs that actually have therapeutic effect.

Although India exports huge quantities of finished generic drugs, it relies heavily on imported APIs: Almost 70% come from China, Indian government data shows. In 2020, India rolled out nearly $1 billion worth of incentives to encourage companies to manufacture more key drug materials locally.

These incentives appear to be helping, although the opaque nature of the global generics-manufacturing supply chain makes it tough to draw definitive conclusions.

Data from U.S. Pharmacopeia, an industry nonprofit focused on standard setting and the safety of the drug supply chain, shows that India accounted for 62% of active Drug Master File registrations for APIs in 2021, the highest percentage since at least 2000. With comprehensive global data on actual drug-manufacturing capacity difficult to come by, U.S. Pharmacopeia treats DMFs as a rough proxy: They indicate how many facilities have submitted confidential data to the FDA to demonstrate their ability to safely make APIs.

China, however, also appears to be gaining ground. The nation accounted for 23% of such DMFs filed in 2021, up from 18% in 2019.

India has a chance to muscle in on China's dominance upstream in the generic-medicine sector as advanced economies become increasingly leery of overdependence on an emerging strategic rival. But nothing is guaranteed. Tighter regulatory oversight and more extensive site inspections, at the very least, will be needed to shore up its reputation for quality -- not just the right price."[1]

1.  Gambia Tragedy Imperils India's Drug Efforts
Mandavia, Megha. 
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 13 Oct 2022: B.11.