After the World Health Organization linked Indian-made cough syrup to acute kidney failure, leading to the deaths of nearly 70 children in West Africa, Indian authorities shut down a factory near Delhi where the medicines were made. But it took them a full week. The plant's manufacturing was suspended only after a joint investigation between the state and federal drug regulating authorities exposed 12 violations.
WHO's laboratory analysis said the cough syrups contained "unacceptable amounts of diethylene glycol and ethylene glycol," chemicals often meant for industrial use.
The company has responded by defending its manufacturing process, and India's federal drug regulator has disputed WHO's findings.
This isn't just a one-time problem. In the past, cough syrups have been linked to other mass poisonings of children in India as well as other countries.
The issue, activists say, is a longstanding laxness in regulating India's booming pharmaceutical industry.
India exports medicines to over 200 countries and contributes to a large generic market in the United States. Its pharmaceutical industry is one of the largest by volume and has a current turnover of $50 billion. But critics say that government oversight is sorely lacking, which can breed conditions that lead to dangerous violations.
That's the argument that public health activist Dinesh S. Thakur and lawyer Prashant Reddy T. make in their new book The Truth Pill: The Myth of Drug Regulation in India.
In 2016, they took their concerns about drug manufacturing to the Supreme Court of India, which dismissed their petitions. So they filed more than 400 Right to Information Act requests to collect as many facts as possible for their book. In an interview with NPR over phone and email, Reddy and Thakur discuss the state of India's pharma industry.
The 70 children in Gambia whose deaths are linked to Indian cough syrup have made international headlines. Have there been other incidents like this that aren't as well known?
Dinesh Thakur: It is tragic that these incidents continue to occur with such frequency. In fact, we open our book, The Truth Pill, recounting how mass poisoning of children with DEG [diethylene glycol] contaminated syrup has become such a routine event. In India, there have been five such cases since 1972: In 1972 in Madras (now called Chennai) that killed 15 children, in 1986 in Mumbai that took the lives of 14 patients, in Bihar in 1988 killing 11, in Gurgaon in 1998 that killed 33 children and then this last one in Jammu in December 2019 killing 11 children. In any other country, this would have never been acceptable. Somehow it seems not to bother our conscience here in India.
You've petitioned the Health Ministry after the Jammu tragedy, and before that, the Supreme Court. What did you ask for?
Thakur: We tried to ask the court to intervene when our pleas to the Ministry of Health basically went unheard and unacknowledged. For example, when the DEG poisoning tragedy happened in Jammu, we wrote a petition to the then health minister asking for a transparent and a timely investigation so that we could learn how to prevent such mass casualties.
Do you feel as if you made any progress?
Thakur: Well, we are here now with what happened in Gambia. The sad part is that neither the bureaucracy nor the political class seems to be interested in addressing the issues we raise. Therefore, we really had no other option but to put this information in the public in the form of a book and hope that people read about it and demand change from their elected representatives. The book is really a deep dive into the history and reality of drug regulation in India.
How common a problem is contamination in Indian drugs?
Reddy: The fact that we have had five mass casualty events since 1972 tells you how common this phenomenon is. What happened in Gambia is a case of contamination — chemical toxins finding their way into cough syrups. [In their book they say that contamination happens because "Indian pharmaceutical companies quite often fail to test either the raw materials or the final formulation before shipping it into the market."]
Is contamination the only problem that needs to be addressed?
Reddy: There is another widely prevalent problem of substandard [poor quality] drugs — drugs that don't work as effectively as they should. Unfortunately, we don't have a national database that gives us figures from every state. So we cannot really speculate on the numbers.
Why is regulating manufacturers such a challenge in India?
Reddy: In India, we do have good manufacturing processes standards as part of the law since 1988, but it doesn't operate in the same way as in the U.S. In the U.S., there's extensive documentation that manufacturers must comply with and this ensures quality. If the Indian manufacturer does not follow [those] standards, their license can be canceled, but they cannot be prosecuted.
What is the best way to ensure that drug manufacturers are more accountable?
Thakur: People of India cannot hold [drug manufacturers] accountable if they refuse to release any information about how they function. Sunlight is the best disinfectant; the functioning of the regulator — whether it is the way it approves new drugs, inspects manufacturing facilities, prosecutes wrongdoers — it all ought to be public. After all, these are not state secrets.
Reddy: We really need a centralized federal authority governing the manufacturing process and enforcing laws. In India, every state and union territory has its own jurisdiction — we have as many as — and so enforcing laws against poor manufacturing processes is difficult.
Is there cause to worry about the government's vigilance in regulating pharma, even within the country?
Reddy: The government's own data says this: Test results from just three states, Gujarat, Kerala and Maharashtra, over the last decade have documented over 7,500 samples that failed quality tests.
If you include data from Tamil Nadu (collected under the Right to Information Act) and the data from the [federal] Central Drugs Standard Control Organization, this number is over 12,000. Mind you, each failed sample represents hundreds of thousands of pills, syrups and injectables that have been consumed by patients all across the country. These include all kinds of failures including contamination by glass particles and bacterial endotoxins.
India has often been hailed as the pharmacy of the world. But insiders say that the quality of drugs that are shipped to different countries vary widely, depending on how carefully the imported drugs are inspected. Is this true?
Reddy: Yes, a study conducted by academics in the U.S. and Canada in 2014 provided empirical data to substantiate this. [Poor quality drugs, most notably says the study, find their way to Africa]. The tragedy in Gambia is one such example.
You've also recently tweeted to call attention to the contaminated cold and cough syrups being sold by Maiden Pharmaceuticals under different brand names, saying that there is still cause for worry.
Thakur: I meant to counter this narrative that was being propagated by the government that the poisonous syrups that the WHO flagged in its alert were somehow not worrisome for us in India. The messaging from the Ministry that since these were "manufactured" only for export, we in India have nothing to worry about. What I tried to show through that thread is that the very company was selling cough syrup to children in India, albeit under a different brand. Now, given what we know about how broken their manufacturing processes are, how can one be sure that such contamination will not seep into other cough syrups made by this company and sold in India?
Kamala Thiagarajan is a freelance journalist based in Madurai, Southern India. She reports on global health, science, and development, and her work has been published in the New York Times, The British Medical Journal, BBC, The Guardian and other outlets. You can find her on twitter @kamal_t
