Democracy Dies in Darkness

BUSINESS

Just How Dangerous Are India’s Generic Drugs? Very

For a nation that seeks to claim the mantle of “pharmacy to the world,” India is scandalously short on regulatory
oversight. In the last six months alone, its generic cough syrups have killed dozens of children, its eye drops have
caused blindness and its chemotherapy drugs have been contaminated.

The children who died — mostly under the age of five years — were given Indian-made over-the-counter
products contaminated with industrial solvents and antifreeze agents that are fatal in even small amounts. The
eye drops that contained extensively drug-resistant bacteria? So far 68 patients across 16 US states have been
affected. Three people died, several had to have their eyeballs removed, some went blind, the Centers for Disease
Control and Prevention reported on March 21. The Indian company, Global Pharma Healthcare, issued
a voluntary nationwide recall for the drops.

India is the largest provider of generic medicines, producing 20% of the world’s supply, according to the
government’s Economic Survey. Its $50 billion drug-manufacturing industry exports medicines to over 200
nations and makes 60% of all vaccines. It boasts “the highest number” of US Food and Drug Administration
compliant plants outside America, and indeed, some of its generic pharmaceutical companies produce high-
quality medicines.

That may well provide consumers with a level of comfort, but history suggests it is unwise to trust that feeling.

The latest drug recalls just add to a long line of scandals that have tainted the sector. In 2013, a US subsidiary of
major Indian drug manufacturer Ranbaxy Laboratories Ltd. pleaded guilty to US federal criminal charges and
agreed to pay $500 million for selling adulterated generic drugs, fabricating data, and committing fraud. Serious
flaws in the FDA compliance regime allowed these breaches to go undiscovered, until a years-long investigation
laid bare the endemic corruption. A generic drug made in India and modeled on Lipitor sold in the US to
treat high cholesterol, for example, was contaminated with shards of blue glass, as journalist Katherine Eban
documented in her book, Bottle of Lies: The Inside Story of the Generic Drug Boom. Her book draws in part on
the experience of whistleblower Dinesh Thakur, who worked at Ranbaxy.

You would think such a damning indictment would prompt India to develop a safer, better pharmaceutical
oversight regime. Think again. The systemic fraud exposed by the investigation — where data was routinely
falsified to fool inspectors, increase production and maximize profit — did not result in a regulatory overhaul.
Still, a two-day “brainstorming session” held in February appeared to acknowledge the system’s inherent
weaknesses, with Health Minister Mansukh Mandaviya telling participants India needed to “move from generic
to quality-generic drugs.” Discussions involved “how to make the country’s drugs regulatory systems
transparent, predictable and verifiable,” according to a health ministry media release. Consumers shouldn’t hold
their breath, though. A national law on drug recalls has been under discussion since 1976 without resolution, and
the government — at least publicly — remains in denial:

Since the Ranbaxy scandal, Thakur has campaigned for the reform of India’s main regulator, the Central Drugs
Standard Control Organisation, and, with lawyer T. Prashant Reddy, has written his own book, The Truth Pill:
The Myth of Drug Regulation in India, which was published in October.

They note that adulterated Indian drugs aren’t just killing children in developing-world export markets
like Gambia and Uzbekistan. They’re also killing children at home: In 2019, at least 11 infants died in the state of
Jammu because of cough syrup containing diethylene glycol. Indeed, as Thakur notes, the mass poisoning of
children with medication containing DEG has happened in India on five previous occasions — in one 1998 case,
36 children died due to acute renal failure after consuming contaminated cough syrup.

And here we are.

The World Health Organization sent alerts in October and January, asking for the cough medicine to be removed
from the shelves. (It also issued a warning last year for cough syrups made by four Indonesian manufacturers
sold in that country, where 203 children died in similar circumstances.)

Maiden Pharmaceuticals, whose medicines were sold in Gambia and linked by the WHO to the deaths of at least
70 children, has denied wrongdoing. And India’s regulator rejected the WHO’s findings, saying no toxic
substances had been found in samples taken from Maiden’s plant. CDSCO Director General V.G. Somani said the
warning caused “irreparable damage” to the reputation of the Indian pharmaceutical industry, Bloomberg News
reported in January.

Then came the reports of at least 18 deaths in Uzbekistan linked to another batch of children’s cough
syrup manufactured by another Indian company, Marion Biotech Ltd. This time there was some action, and
on March 22, the company’s manufacturing license was revoked.

It shouldn’t have taken more deaths for Prime Minister Narendra Modi’s administration to act. The red flags
have been there for years. What’s lacking is political will, and transparency. The FDA publishes different reviews
of new drug applications on its website, along with detailed notes. The European Medical Agency gives similarly
expansive information. There is no such openness in India.

As Thakur explained to me, the pharmaceutical industry is India’s manufacturing success story, providing a
major source of foreign exchange and soft power. Any criticism is seen through the lens of nationalism, he
said, and framed as defaming the industry. So why does contamination with such deadly substances occur so
regularly? “The simple answer is that Indian pharmaceutical companies quite often fail to test either the raw
materials or the final formulation before shipping it to market,” Thakur said.
India relies on the weak oversight of developing countries that make up the bulk of its exports — that’s how it can
continue to push substandard and often deadly medicines there. As a paper on the Gambia poisonings published
in March by the CDC noted, “inadequate regulatory structures make the sale of medications from international
markets an especially high-risk activity in low-resource settings.” But what about countries with supposedly
strong regulatory systems, like the US? This latest scare should prompt further reform of the FDA’s overseas
inspections regime.

In the absence of a global framework for pharmaceutical safety, what can be done to make the generic drugs that
consumers around the world have come to rely on safer and effective? For a start, the WHO’s prequalification
program, which facilitates the purchase of billions of dollars’ worth of medicines through international agencies
such as Unicef, must be overhauled. Then there’s the question of holding these companies to account for the
harm they cause inside and outside India via legal avenues and victim’s compensation.

In a year that India holds the Group of 20 presidency, it should drag its pharmaceutical industry out of the dark
ages and into the real world — one that is driven by transparent, evidence-based medicine and real safety data
shared across borders. Its export partners should demand nothing less.

More From Bloomberg Opinion:

• No, Vaccines Aren’t Making New Covid Variants Worse: Faye Flam

• India Is in Danger of Missing Its Big G-20 Moment: Pankaj Mishra

• Now the UK Has to Wrestle With India’s Demons, Too: Mihir Sharma

This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.

Ruth Pollard is a Bloomberg Opinion editor. Previously she was South and Southeast Asia government team
leader at Bloomberg News and Middle East correspondent for the Sydney Morning Herald.

More stories like this are available on bloomberg.com/opinion

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