 "pharma, pharma firm, medicines")
By Ruth Pollard
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.
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.
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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:
Made in India pharma products are saving precious lives globally!
— Dr Mansukh Mandaviya (@mansukhmandviya) April 1, 2023
The exports of pharma products increased by 2.37 times in April-February 2022-23 as compared to the same period in 2013-14. pic.twitter.com/MiYWr4HuWf
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.
Disclaimer: This is a Bloomberg Opinion piece, and these are the personal opinions of the writer. They do not reflect the views of www.business-standard.com or the Business Standard newspaper
