If you have been meditating in a cave or under a rock, or just been in a bubble due to the pandemic, you may have missed the news of children dying every now and then of cough syrup. We have known, for more than 50 years now, that diethylene glycol (DEG) is a fatal contaminant in cough syrups but, sadly, it continues to kill kids in India and, most recently, in The Gambia.
It’s an eerie coincidence that The Truth Pill by Dinesh Thakur and Prashant Reddy starts with “An Epidemic of DEG Poisoning and Regulatory Failure” as its prologue and the book was released days after the tragedy in The Gambia.
The Truth Pill feels like a follow-up on an earlier book, Bottle of Lies by Katherine Eban, especially Chapter 6: Can ‘Made in India’ Generic Medicine be Trusted? In many ways, The Truth Pill echoes the key themes of Ms Eban’s excellent book – poor manufacturing standards and quality control, and negligent regulators in the pharma industry. Bottle of Lies should have been a wakeup call for the Indian pharma sector.
Mr Thakur, a well-known public health activist with great depth and breadth of knowledge of the pharmaceuticals industry, and Mr Reddy, the rare lawyer-academic (student of the enigmatic, late Prof Shamnad Basheer), lucidly tell us how the world, not just India, is at risk from the Indian pharma sector. The book is likely to make you paranoid about every pill you take, especially since it is easy to read, despite it being meticulously referenced, in the style of Manu Pillai and William Dalrymple.
If you are living in the previous century but visiting the present, you will notice that the book addresses issues in the medical cures business that are just the same now as they were then—miracle cures advertised by snake oil merchants, poor quality drugs, the recklessness of government and regulators not caring about the lives of its people and people in other countries where these substances are being exported, the influence of the pharma industry on law making and enforcement, public relations (PR) and spin to resist effective regulations and enforcement, and the people dying due to all this.
For those who have been following the Indian pharma industry, the book, a product of extensive research and proactive Right to Information applications, provides a good summary of everything that’s wrong and, despite recommendations for reform, why one shouldn’t be optimistic about it getting better any time soon.
There is no bar on these companies making millions from these products today with unsuspecting customers and pliant regulators.
How the Regulator Lets Us Down
At the heart of the book is a severe indictment of the regulator. Page after page exposes how the government seems to be doing everything it can to ensure that the regulator is nothing more than a champion of the pharma industry, at the cost of people’s lives.
The book has extensive data showing how the government and the regulator:
1. Refuse to have appropriate legislative instruments to empower them;
2. Undermine the law by issuing guidelines to officers directing them not to prosecute criminals;
3. Discourage drug inspectors from collecting evidence of dangerous drugs;
4. Ensure that laboratories are so ill-equipped that they cannot test drugs for adherence to statutory quality standards;
5. Do not appoint enough staff to be able to enforce regulations;
6. Encourage prosecutors to file poor evidence and for criminals to be either acquitted or discharged in most cases;
7. Are happy to have the judiciary treat criminals with a petty fine in the few cases where they are held guilty;
8. Do not press for even the statutory minimum sentences and
9. Even when it is known that there is a fatal product being sold, nothing is being done to recall them quickly, as is common in the US and other developed nations, to prevent further injury or loss of lives.
These issues have been discussed for almost 90 years now and yet they remain potent in India.
I couldn’t believe how bad it was and so I checked all reported cases in the high courts and the Supreme Court (SC) for instances where the statutory minimum punishment was awarded. I should not have been shocked by the result—Mr Thakur and Mr Reddy had done their research thoroughly—there wasn’t one case in almost 70 years for which I was able to search the SCC online database.
How It Works Elsewhere
Why doesn’t any other country have frequent DEG or similar tragedies? The book tells us that pharma companies there are allowed by the drug regulator to manufacture only those drugs that have proved to be effective in rigorous clinical trials and only after the facility is inspected thoroughly for strict compliance with good manufacturing practice. Pharma companies are careful to purchase raw materials only from approved suppliers who have good manufacturing practices.
They then test the raw materials to the quality standards in the US pharmacopeia and test for quality standards at various stages of manufacturing. They maintain accurate manufacturing records and product samples for future testing when quality issues arise. If something goes wrong, they immediately recall all products and identify the root cause of the quality issue and implement corrective and preventive actions. The pharma regulator there is transparent about its working—particularly approvals, inspections, and enforcement actions, and diligent about performing its duties, the most important being protection of the health of the people.
As a result, all stakeholders are incentivised to comply with the law. Those who try to cut corners are severely punished with fines and imprisonment, a clear disincentive to try to evade the law.
The book makes a larger point about India and Indians—there is no incentive to comply with the law, there is a huge incentive to violate the law to make profits, there is no risk of punishment for ignoring the law. Most alarmingly, the State, whose raison d’etre is protection of the people, is a perpetrator in the crime. It should make every one of us wonder, are we a civilized nation governed by the rule of law? Sadly, it seems like the lawless Wild West, with fearless cowboys and gunmen and a complicit government and regulator.
For all those who are now ready to claim the greatness of Ayurveda and homeopathy, please sit down and have a glass of cold water. Please read the approved Ayurvedic texts listed in the Schedule to the Drugs Act to realise how scary and irrational the remedies listed there are, check the ingredients in these potions to understand the risk to health, how easily these are approved and advertised without a shred of scientific evidence, and the lack of actual standards for their manufacturing. The regulatory framework is, if you can even imagine it, much worse there and the consequences for patients are much worse than in modern medicine.
When the government tried to update the law so that all claims (ayurveda, unani, siddha and Homeopathy) are subject to a scientific standard, and only scientific claims are allowed to be made about the products, several Indian and even multinational companies (like Reckitt Benckiser which makes Strepsils, Moov, Krack cream and Dermicool talcum powder) cried foul and went to the Delhi High Court in 2019. There is no bar on these companies making millions from these products today from unsuspecting customers.
There is so much wrong with India’s drug industry that it could be a television series, starting with the sequence of disastrous steps taken during the pandemic—advocating widespread use of hydroxychloroquines (HCQs), virafin, favipiravir and ivermectin, homemade ‘kadhas’ and other dubious ‘immunity boosters’, approving vaccines without adequate clinical trials and even ignoring the nudge from the SC on using flexibilities of trade-related aspects of intellectual property rights (TRIPs) to ensure adequate supplies of essential drugs and equipment. Just the issues and instances that Mr Thakur and Mr Reddy have identified could make it gripping.
Sadly, despite all this, issues of health and state of drug regulation, which is killing Indians and people overseas, gets no mention in political debates. Health activists fighting for patients get no platform and courts have ignored them, or even worse, actively prevented them from seeking to make the regulator accountable while every day patients die.
Rather than seeing the book as a depressing list of all the maladies of the pharma sector, one ought to read it to understand the various issues and then appreciate the recommendations that the authors make to address these. To dismiss the book, as some have tried to do and dissing it as a ‘part of a global conspiracy to malign India’, is the reason that we continue to have dangerous products in the pharmaceutical market. There is much to be proud of being the pharmacy of the world but, as Mr Thakur and Mr Reddy show us, there are too many dangerous players here. The way to save India’s reputation is to reform quickly to eliminate these rotten apples.
One may read the authors’ recommendations for reform and wonder why these reasonable suggestions, many of which have been made before, haven’t been implemented. Many of these issues have been discussed for more than a century and they aren’t unique to India. Other countries have learnt that scientific evidence and objective data should inform policy making. They have reformed their regulatory ecosystem by actively responding to challenges as and when they have arisen. Why won’t India and Indians learn?
Despite the disappointing history of the pharmaceutical sector that the book describes, I hope that it will spark reform in the pharmaceutical industry and India will take its place as a leader in global healthcare. It's been long overdue. India deserves it. The world needs it. Mr Thakur and Mr Reddy have done us a great service and we owe them a huge debt of gratitude. The least we could do is to read the book to be more aware of what’s happening to us. It should move us to demand more from government.
The Truth Pill: The Myth of Drug Regulation in India
Dinesh Singh Thakur and Prashant Reddy Thikkavarapu
Published: 10 October 2022
Length: 508 pages
List Price: Rs899
(Murali Neelakantan is Principal Lawyer at amicus. He is a dual qualified (English solicitor and Indian advocate) and has previously been Global General Counsel at Cipla and Glenmark. .)