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The Truth Pill: The Myth of Drug Regulation in India
Since 2004, when the fraud at Ranbaxy, the largest Indian pharmaceutical company at the time first came to light, the Indian pharmaceutical industry and clinical research organizations have been rocked by a series of scandals after investigations by American and European drug regulators. While the West has responded to concerns about quality of “Made in India” medicine by blocking exports from many Indian pharmaceutical companies, the Indian government responded not with regulatory reform but conspiracy theories about “vested interests” working against India.
More worryingly, the Indian state has also turned a blind eye to a far more serious quality crisis in its domestic pharmaceutical market. At times, these quality issues manifest themselves in the deaths of Indian citizens as happened in early 2020 when 11 children died in Jammu because of adulterated cough syrup. On other occasions, a dodgy drug approval process has led to the Indian regulator approving sales of drugs that have never been approved by regulators in the developed markets. The result is not just poor health outcomes but outsize profits for pharmaceutical companies manufacturing medicines that have never been validated through scientifically rigorous clinical trials for therapeutic evidence.
These twin crises, in both the domestic and export markets, is because India has either outdated regulations or no regulations in some areas. Even the outdated regulations are enforced with kid gloves by drug inspectors and judicial magistrates who are ready to forgive even those whose drugs are found to contain barely any active ingredient or dangerously high levels of bacterial endotoxins. In a race for growth of the pharmaceutical industry, the Indian state has sacrificed scientific rigour and ignored the basic principles of public health. Given India’s position as the pharmacy of the developing world, the failure of the Indian state is a problem for not just India but most of the developing world.
This timely, important and compelling book based on deep research, questions and analyzes the actions of the institutions that are responsible for the safety and efficacy of the Indian drug supply in the context of the historical evolution of the Drugs Act 1940 from pre-Independence India to the present day. The future of Indian public health lies in responding to the issues raised in this book.
More worryingly, the Indian state has also turned a blind eye to a far more serious quality crisis in its domestic pharmaceutical market. At times, these quality issues manifest themselves in the deaths of Indian citizens as happened in early 2020 when 11 children died in Jammu because of adulterated cough syrup. On other occasions, a dodgy drug approval process has led to the Indian regulator approving sales of drugs that have never been approved by regulators in the developed markets. The result is not just poor health outcomes but outsize profits for pharmaceutical companies manufacturing medicines that have never been validated through scientifically rigorous clinical trials for therapeutic evidence.
These twin crises, in both the domestic and export markets, is because India has either outdated regulations or no regulations in some areas. Even the outdated regulations are enforced with kid gloves by drug inspectors and judicial magistrates who are ready to forgive even those whose drugs are found to contain barely any active ingredient or dangerously high levels of bacterial endotoxins. In a race for growth of the pharmaceutical industry, the Indian state has sacrificed scientific rigour and ignored the basic principles of public health. Given India’s position as the pharmacy of the developing world, the failure of the Indian state is a problem for not just India but most of the developing world.
This timely, important and compelling book based on deep research, questions and analyzes the actions of the institutions that are responsible for the safety and efficacy of the Indian drug supply in the context of the historical evolution of the Drugs Act 1940 from pre-Independence India to the present day. The future of Indian public health lies in responding to the issues raised in this book.
506 pages, Kindle Edition
Published October 10, 2022
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November 10, 2022
A Truth Pill in a Bottle of Lies
Medicines are supposed to make you feel better. There may well be side effects, but on the whole, the outcome of taking a medicine is an overwhelmingly positive one. Unless that medicine happens to be a cough syrup that contains DEG.
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 DEG is a fatal contaminant in cough syrups but sadly, it continues to occasionally kill kids in India and most recently, in Gambia. In an eerie and entirely unwanted coincidence, The Truth Pill by Dinesh Thakur and Prashant Reddy starts with “An Epidemic of DEG Poisoning and Regulatory Failure” as its prologue. The book, of course, was released only days after the tragedy in Gambia.
In some ways, ‘The Truth Pill’ feels like a follow up on an earlier book, ‘Bottle of Lies’ by Katherine Eban. This feeling manifests especially strongly in the case of Chapter 6: ‘Can ‘Made in India’ Generic Medicine be Trusted?’
In many ways, the Truth Pill reinforces the key themes of 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. Thakur, a well known public health activist with great depth and breadth of knowledge of the pharmaceutical industry and Reddy, a rare case of a lawyer who became an academician, lucidly tell us how the world (and 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 being meticulously referenced, a la Manu Pillai and William Dalrymple. Given Thakur’s meticulous nature, and the fact Reddy was a student of the enigmatic, late Prof Shamnad Basheer, this isn’t exactly a surprise.
If you are living in the previous century but happen to visit the present using a time machine, you will notice that the book addresses issues in the medical business that are just the same now as they were then. We have now, as we did then, miracle cures advertised by dubious snake oil merchants. We also have drugs of extremely poor quality. A bad situation is then exacerbated by the recklessness of government and regulators not caring about the lives of its own citizens, let alone people in other countries where these substances are being exported. Throw in the influence of the pharma industry on law making and enforcement, a well-oiled PR machinery to resist effective regulations and enforcement and it is hardly a surprise that lives are still being needlessly sacrificed as a tragic consequence.
One of the book’s underrated strengths is its reliance on two factors: extensive research and proactive RTI applications. It is therefore able to provide a good summary of everything that’s wrong with India’s medical care industry. One wishes this were not the case, but notwithstanding the book’s excellent recommendations for reform, it also makes clear why one shouldn’t be optimistic about the situation getting better any time soon.
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, even at the cost of people’s lives.
The book has extensive data showing how in every instance, the government and the regulator (i) refuse to have appropriate legislative instruments to empower them, (ii) undermine the law by issuing guidelines to officers directing them not to prosecute criminals, (iii) discourage drug inspectors from collecting evidence of dangerous drugs (iv) ensure that laboratories are so ill equipped that they cannot test drugs for adherence to statutory quality standards (v) do not appoint enough staff to be able to enforce regulations (vi) encourage prosecutors to file poor evidence and for criminals to be either acquitted or discharged in most cases (vii) are happy to have the judiciary treat criminals with a petty fine in the few cases where they are held guilty (viii) do not press for even the statutory minimum sentences and (ix) 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 USA 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 ever more potent in India.
We must confess that we couldn’t believe that the situation was quite as bad as the book makes it out to be. One of us checked all of the reported cases in the High Courts and the Supreme Court for instances where the statutory minimum punishment was awarded. We shouldn’t have been shocked by the result – Dinesh Thakur and Prashant Reddy had done their research thoroughly – there wasn’t one case in almost 70 years for which we were able to successfully search the SCC Online database.
Why doesn’t any other country have frequent DEG or tragedies of a similar nature? The book tells us that pharma companies there (i) 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 (ii) are careful to purchase raw materials only from approved suppliers who have good manufacturing practices (ii) test the raw materials to the quality standards in the US pharmacopeia (iii) test for quality standards at various stages of manufacturing (iv) maintain accurate manufacturing records and product samples for future testing (v) when quality issues arise, immediately recall all products (vi) identify the root cause of the quality issue and implement corrective and preventive actions.
Moreover, the pharma regulator there is (i) transparent about its working – particularly approvals, inspections and enforcement actions, and (ii) diligent about performing its duties, the most important being protection of the health of the people. As a result, all stakeholders are incentivized 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 and 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 realize how scary and irrational the remedies listed there are. Please 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 (Strepsils, Moov, Krack cream and Dermicool talcum powder) and GSK (Eno and Iodex are claimed to be Ayurvedic products) cried foul and had the amendments stayed by the Delhi High Court in 2019. That injunction continues without the issue being resolved by the court.
There is so much wrong with India’s drug industry that it could be a Netflix series, starting with the sequence of disastrous steps taken during the pandemic - advocating widespread use of 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 Supreme Court on using TRIPs flexibilities to ensure adequate supplies of essential drugs and equipment. Sadly, despite all this, issues of health and the current state of drug regulation 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 when it comes to being the pharmacy of the world but, as Thakur and Reddy show us, there are far 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?
“What we have learnt from history is that we don’t learn from history.”
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. Thakur and 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 the government.
Medicines are supposed to make you feel better. There may well be side effects, but on the whole, the outcome of taking a medicine is an overwhelmingly positive one. Unless that medicine happens to be a cough syrup that contains DEG.
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 DEG is a fatal contaminant in cough syrups but sadly, it continues to occasionally kill kids in India and most recently, in Gambia. In an eerie and entirely unwanted coincidence, The Truth Pill by Dinesh Thakur and Prashant Reddy starts with “An Epidemic of DEG Poisoning and Regulatory Failure” as its prologue. The book, of course, was released only days after the tragedy in Gambia.
In some ways, ‘The Truth Pill’ feels like a follow up on an earlier book, ‘Bottle of Lies’ by Katherine Eban. This feeling manifests especially strongly in the case of Chapter 6: ‘Can ‘Made in India’ Generic Medicine be Trusted?’
In many ways, the Truth Pill reinforces the key themes of 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. Thakur, a well known public health activist with great depth and breadth of knowledge of the pharmaceutical industry and Reddy, a rare case of a lawyer who became an academician, lucidly tell us how the world (and 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 being meticulously referenced, a la Manu Pillai and William Dalrymple. Given Thakur’s meticulous nature, and the fact Reddy was a student of the enigmatic, late Prof Shamnad Basheer, this isn’t exactly a surprise.
If you are living in the previous century but happen to visit the present using a time machine, you will notice that the book addresses issues in the medical business that are just the same now as they were then. We have now, as we did then, miracle cures advertised by dubious snake oil merchants. We also have drugs of extremely poor quality. A bad situation is then exacerbated by the recklessness of government and regulators not caring about the lives of its own citizens, let alone people in other countries where these substances are being exported. Throw in the influence of the pharma industry on law making and enforcement, a well-oiled PR machinery to resist effective regulations and enforcement and it is hardly a surprise that lives are still being needlessly sacrificed as a tragic consequence.
One of the book’s underrated strengths is its reliance on two factors: extensive research and proactive RTI applications. It is therefore able to provide a good summary of everything that’s wrong with India’s medical care industry. One wishes this were not the case, but notwithstanding the book’s excellent recommendations for reform, it also makes clear why one shouldn’t be optimistic about the situation getting better any time soon.
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, even at the cost of people’s lives.
The book has extensive data showing how in every instance, the government and the regulator (i) refuse to have appropriate legislative instruments to empower them, (ii) undermine the law by issuing guidelines to officers directing them not to prosecute criminals, (iii) discourage drug inspectors from collecting evidence of dangerous drugs (iv) ensure that laboratories are so ill equipped that they cannot test drugs for adherence to statutory quality standards (v) do not appoint enough staff to be able to enforce regulations (vi) encourage prosecutors to file poor evidence and for criminals to be either acquitted or discharged in most cases (vii) are happy to have the judiciary treat criminals with a petty fine in the few cases where they are held guilty (viii) do not press for even the statutory minimum sentences and (ix) 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 USA 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 ever more potent in India.
We must confess that we couldn’t believe that the situation was quite as bad as the book makes it out to be. One of us checked all of the reported cases in the High Courts and the Supreme Court for instances where the statutory minimum punishment was awarded. We shouldn’t have been shocked by the result – Dinesh Thakur and Prashant Reddy had done their research thoroughly – there wasn’t one case in almost 70 years for which we were able to successfully search the SCC Online database.
Why doesn’t any other country have frequent DEG or tragedies of a similar nature? The book tells us that pharma companies there (i) 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 (ii) are careful to purchase raw materials only from approved suppliers who have good manufacturing practices (ii) test the raw materials to the quality standards in the US pharmacopeia (iii) test for quality standards at various stages of manufacturing (iv) maintain accurate manufacturing records and product samples for future testing (v) when quality issues arise, immediately recall all products (vi) identify the root cause of the quality issue and implement corrective and preventive actions.
Moreover, the pharma regulator there is (i) transparent about its working – particularly approvals, inspections and enforcement actions, and (ii) diligent about performing its duties, the most important being protection of the health of the people. As a result, all stakeholders are incentivized 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 and 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 realize how scary and irrational the remedies listed there are. Please 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 (Strepsils, Moov, Krack cream and Dermicool talcum powder) and GSK (Eno and Iodex are claimed to be Ayurvedic products) cried foul and had the amendments stayed by the Delhi High Court in 2019. That injunction continues without the issue being resolved by the court.
There is so much wrong with India’s drug industry that it could be a Netflix series, starting with the sequence of disastrous steps taken during the pandemic - advocating widespread use of 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 Supreme Court on using TRIPs flexibilities to ensure adequate supplies of essential drugs and equipment. Sadly, despite all this, issues of health and the current state of drug regulation 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 when it comes to being the pharmacy of the world but, as Thakur and Reddy show us, there are far 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?
“What we have learnt from history is that we don’t learn from history.”
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. Thakur and 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 the government.
May 3, 2023
Last year I started working in a project related to drug regulation in Europe. I read about the European guidelines but wasn't really convinced to have multiple review/approval requirements for the product that we build. I came to know about this book at the same time, so why not read about Indian drug regulation also? and this book changed my opinion.
This is a detailed book illustrated in simple language that is easier to understand even for an outsider like me. The evolution of drug regulation, the broken Indian system, the chaos created by the traditional medicine all these are supported with enough data points throughout. I was advocating for the generic medicine prescription but got the answer in the book why the medical community was opposing it.
Must must read.
This is a detailed book illustrated in simple language that is easier to understand even for an outsider like me. The evolution of drug regulation, the broken Indian system, the chaos created by the traditional medicine all these are supported with enough data points throughout. I was advocating for the generic medicine prescription but got the answer in the book why the medical community was opposing it.
Must must read.
May 24, 2023
The Subjectivity of classified pharma society, exploring the possibility of confidential power support and the collective action of Indian drug regulation, stares at the bureaucratic quid pro quo of the pharma world in a brutal way. These are all the things one can expect from this book.
Dinesh S Thakur, a public health advocate who exposed the generic drug industry's dark underbelly, writes persuasively about Indian Pharma's unethical practices. The Truth Pill delves into numerous tragedies and strategies, including surging death rates due to drug adulteration and contamination, violation of manufacturing regulation, and sale of NSQ or spurious drugs - that uses the drug regulatory system itself as a loophole.
Following his experiences with the RANBAXY, and the dysfunctional regulatory methods, he resolves to address these structural flaws and expose corporate malfeasance. But I felt the pages read more about the judiciary and legal dominance than corporate involvement to keep things in the dark. (And I love that subtle punch of the brilliant minds behind the open text!)
It is always fascinating to read a book that offers real-time details using government records and data, and Thakur and Prashant have used those RTI replies and other records to back up their claims well. There is no doubt about it. But they must take note of why the government-provided data should necessarily be true (which exquisitely helps fix the regulatory mechanism) as the numbers can be fabricated.
This book is a dip in analogue of times since pre-independence - and a comprehensive manual on how we could navigate regulatory compliance for the betterment of the healthcare system and offer a reliable systemic industry as a whole. With a clear and linear prose style, this book evenly explores legally-binding-and-medically-contending elements that make it accessible to the average reader to grasp the gravity even better -(revealing the hardest plain truths to keep you on your toes!) - And also unearths the detrimental impact of bureaucratic delays on drug regulations, spanning from investigation disposition to quality standards and supply chain failures. That is not at all what this book holds within. There are many instances where I can't shake this question:
Should we really find this lack of transparency and accountability in the drug approval, manufacturing & distribution processes alone at fault? I do not think so. You can't ignore an elephant in the room and then pretend to look for changes somewhere else.
Connection. Conviction. Court system.
In my understanding, these words are not just empty words but ring endorsements at their best of the flip side of our democratic spectrum - that would make anything go downright disastrous and thus increase the proliferation of counterfeit drugs and the augmented risk of public health emergencies.
Thakur divides this book into 11 chapters - where he talks about very plain yet sensitive and tedious bits of statistical events around the Indian drugs credibility, governmental technology-oriented incapacity, lenient legal investigation - and most importantly, the judiciary approach towards the deceptive practices that plague the pharma industry.
In today's India, getting a proper diagnosis is no easy task for a normal citizen. However, this book's unique ability to connect and recontextualize irregularities within a broader framework leaves me fascinated by the extensive work put into its creation. Exploring the details, I realize we are still very far from achieving the constitutional best, and this book ticks all the boxes that need to be addressed within this industry.
Plus, Despite appearing to be a complex and vapid process, I am sure this book is truly worth every second of your time for anyone interested in the future of India's Pharmaceutical industry and the global healthcare system. Trust me, this book will satiate your curiosity!
Dinesh S Thakur, a public health advocate who exposed the generic drug industry's dark underbelly, writes persuasively about Indian Pharma's unethical practices. The Truth Pill delves into numerous tragedies and strategies, including surging death rates due to drug adulteration and contamination, violation of manufacturing regulation, and sale of NSQ or spurious drugs - that uses the drug regulatory system itself as a loophole.
Following his experiences with the RANBAXY, and the dysfunctional regulatory methods, he resolves to address these structural flaws and expose corporate malfeasance. But I felt the pages read more about the judiciary and legal dominance than corporate involvement to keep things in the dark. (And I love that subtle punch of the brilliant minds behind the open text!)
It is always fascinating to read a book that offers real-time details using government records and data, and Thakur and Prashant have used those RTI replies and other records to back up their claims well. There is no doubt about it. But they must take note of why the government-provided data should necessarily be true (which exquisitely helps fix the regulatory mechanism) as the numbers can be fabricated.
This book is a dip in analogue of times since pre-independence - and a comprehensive manual on how we could navigate regulatory compliance for the betterment of the healthcare system and offer a reliable systemic industry as a whole. With a clear and linear prose style, this book evenly explores legally-binding-and-medically-contending elements that make it accessible to the average reader to grasp the gravity even better -(revealing the hardest plain truths to keep you on your toes!) - And also unearths the detrimental impact of bureaucratic delays on drug regulations, spanning from investigation disposition to quality standards and supply chain failures. That is not at all what this book holds within. There are many instances where I can't shake this question:
Should we really find this lack of transparency and accountability in the drug approval, manufacturing & distribution processes alone at fault? I do not think so. You can't ignore an elephant in the room and then pretend to look for changes somewhere else.
Connection. Conviction. Court system.
In my understanding, these words are not just empty words but ring endorsements at their best of the flip side of our democratic spectrum - that would make anything go downright disastrous and thus increase the proliferation of counterfeit drugs and the augmented risk of public health emergencies.
Thakur divides this book into 11 chapters - where he talks about very plain yet sensitive and tedious bits of statistical events around the Indian drugs credibility, governmental technology-oriented incapacity, lenient legal investigation - and most importantly, the judiciary approach towards the deceptive practices that plague the pharma industry.
In today's India, getting a proper diagnosis is no easy task for a normal citizen. However, this book's unique ability to connect and recontextualize irregularities within a broader framework leaves me fascinated by the extensive work put into its creation. Exploring the details, I realize we are still very far from achieving the constitutional best, and this book ticks all the boxes that need to be addressed within this industry.
Plus, Despite appearing to be a complex and vapid process, I am sure this book is truly worth every second of your time for anyone interested in the future of India's Pharmaceutical industry and the global healthcare system. Trust me, this book will satiate your curiosity!
January 29, 2023
Indian pharma sector has emerged as a powerful industry in recent years. We can claim the growth and revolution of economy surrounding the Pharma industry, right now but can we ensure the quality and safety of ‘Made in India’ medicines?
India’s outdated regulation can be proved by the following tragedies- 21 children (mostly infants) from Ramnagar in Jammu suffered from kidney failure due to a cough syrup called COLDBEST. More than 11 children died in this incident. The reason was, this cough syrup contained an industrial solvent to anti-freeze which is restricted as it is fatal for humans. Sold in local pharmacy stores & easily available without prescription, these drugs might not be found on records. But how tragic deaths as such take place? Dinesh S. Thakur and Prashant Reddy’s book, The Truth Pill: The Myth of Drug Regulation of India serves some shocking reveals about the law, accountable representative and its impact on public health.
Being a pharma person I am aware of the security checks a pharma product goes through before reaching you, according to the textbooks of law. However, no one guarantees if the route map for quality was followed. The Truth Pill, is an eye opener for citizens who are forced to depend on a pharmaceutical market which has major quality-crisis.
I think it’s the time for you to search for ‘Ranabaxy fraud 2004’ to question, who is responsible for public health? How many more years until strict drug regulations? Is it really so simple to play with lives of innocent people?
End note- Know your medicines, notice the changes in your regular pharmaceutical products. Ask, when doubtful. Learn a little bit about policies and read this very well researched and absolutely legitimate book. Mind your medicine, public!
India’s outdated regulation can be proved by the following tragedies- 21 children (mostly infants) from Ramnagar in Jammu suffered from kidney failure due to a cough syrup called COLDBEST. More than 11 children died in this incident. The reason was, this cough syrup contained an industrial solvent to anti-freeze which is restricted as it is fatal for humans. Sold in local pharmacy stores & easily available without prescription, these drugs might not be found on records. But how tragic deaths as such take place? Dinesh S. Thakur and Prashant Reddy’s book, The Truth Pill: The Myth of Drug Regulation of India serves some shocking reveals about the law, accountable representative and its impact on public health.
Being a pharma person I am aware of the security checks a pharma product goes through before reaching you, according to the textbooks of law. However, no one guarantees if the route map for quality was followed. The Truth Pill, is an eye opener for citizens who are forced to depend on a pharmaceutical market which has major quality-crisis.
I think it’s the time for you to search for ‘Ranabaxy fraud 2004’ to question, who is responsible for public health? How many more years until strict drug regulations? Is it really so simple to play with lives of innocent people?
End note- Know your medicines, notice the changes in your regular pharmaceutical products. Ask, when doubtful. Learn a little bit about policies and read this very well researched and absolutely legitimate book. Mind your medicine, public!
July 22, 2025
Drug regulation in India is in a very bad shape... We have seen in our practice also that 2 different brand meds with same ingredients have effects which range from very good to none..
The Good Manufacturing Practices (GMP) that US and Europe implemented strictly, saw a very late implementation in India and that too with leniency - the reason given being that so many small pharma units have put in so much money that we have to consider them too! At the cost of public health? So we know where the priorities lie for each government that has come into power - good for public health vs good for the strong pharmaceutical manufacturing units ...
The authors have also considered the traditional medicines in 2 chapters.
Shocking revelations by the deep research done by the authors..
Recommended read..
The Good Manufacturing Practices (GMP) that US and Europe implemented strictly, saw a very late implementation in India and that too with leniency - the reason given being that so many small pharma units have put in so much money that we have to consider them too! At the cost of public health? So we know where the priorities lie for each government that has come into power - good for public health vs good for the strong pharmaceutical manufacturing units ...
The authors have also considered the traditional medicines in 2 chapters.
Shocking revelations by the deep research done by the authors..
Recommended read..
June 5, 2023
The level of research and information is remarkable. Very detailed book that uncovers the actual scenario of pharmaceutical industry.
Eye opener and must read for awareness purpose.
For average reader, the book will be on heavier side since it contains lot of technical terminology in regards to be policy making and court judgement which at times leads to boredom. Overall it is very informative book.
Special thanks to the D.S Thakur and P.Reddy for taking just huge risk and great pain to make public aware about the myth of drug regulation in India. 🫡
Hope this book finds it way to reachout others and make them aware about the same.
Eye opener and must read for awareness purpose.
For average reader, the book will be on heavier side since it contains lot of technical terminology in regards to be policy making and court judgement which at times leads to boredom. Overall it is very informative book.
Special thanks to the D.S Thakur and P.Reddy for taking just huge risk and great pain to make public aware about the myth of drug regulation in India. 🫡
Hope this book finds it way to reachout others and make them aware about the same.
April 13, 2023
A bitter pill to swallow!
Through The Truth Pill: The Myth of Drug Regulation in India, its authors Dinesh S. Thakur and Prashant Reddy T., have made an attempt to shed light on the darkness that prevails in the pharmaceutical industry in India and its regulation.
Through its 11 well-researched and exhaustive chapters the two writers tell the genesis of drug industry in British-India, how the regulations came into existence, the common malpractices of pharma companies and the challengers ahead of them, the laws for regulating the pharma industry in the country and the role of the courts, the involvement of bureaucracy, the concerns around the traditional Indian medicine systems and what can common man do.
For writing the book the two have read court judgements, researched databases, gone through scientific articles published in journals, quoted media reports and also presented personal anecdotes.
The book is a brave attempt because it challenges governments, big pharma firms, the govt.-pharma lobbies, the courts and the bureaucracy.
While reading the book I actually started to become very cynical about the Indian pharma industry. I realized that so many things are going so are at so many levels.
I am sure that this book will not appeal everyone's taste, but everyone should make an attempt to read this book because needless to say the two writers are delving into areas which concerns you and I and should be addressed on an urgent basis. Let us be honest, when was the last time you or your loved one did not pop in a pill.
Through The Truth Pill: The Myth of Drug Regulation in India, its authors Dinesh S. Thakur and Prashant Reddy T., have made an attempt to shed light on the darkness that prevails in the pharmaceutical industry in India and its regulation.
Through its 11 well-researched and exhaustive chapters the two writers tell the genesis of drug industry in British-India, how the regulations came into existence, the common malpractices of pharma companies and the challengers ahead of them, the laws for regulating the pharma industry in the country and the role of the courts, the involvement of bureaucracy, the concerns around the traditional Indian medicine systems and what can common man do.
For writing the book the two have read court judgements, researched databases, gone through scientific articles published in journals, quoted media reports and also presented personal anecdotes.
The book is a brave attempt because it challenges governments, big pharma firms, the govt.-pharma lobbies, the courts and the bureaucracy.
While reading the book I actually started to become very cynical about the Indian pharma industry. I realized that so many things are going so are at so many levels.
I am sure that this book will not appeal everyone's taste, but everyone should make an attempt to read this book because needless to say the two writers are delving into areas which concerns you and I and should be addressed on an urgent basis. Let us be honest, when was the last time you or your loved one did not pop in a pill.
September 8, 2025
3.5 stars
The broken system that was described in this book did not affect only Indians, if your country did not have a strong regulation then it was quite likely that the shoddy and contaminated drugs from India would have made its way into your country in with disastrous consequences like in Indonesia, where in 2022-2023 more than 200 children died (out of 326 children) from acute kidney failure due to contaminated syrup. It was quite possible that the contaminated ingredients was imported from India since India supplied much of the South East Asia countries with cheap drugs and cheap ingredients.
The broken system that was described in this book did not affect only Indians, if your country did not have a strong regulation then it was quite likely that the shoddy and contaminated drugs from India would have made its way into your country in with disastrous consequences like in Indonesia, where in 2022-2023 more than 200 children died (out of 326 children) from acute kidney failure due to contaminated syrup. It was quite possible that the contaminated ingredients was imported from India since India supplied much of the South East Asia countries with cheap drugs and cheap ingredients.
June 6, 2023
The 5 rating reflects the depth and quality of the research.
The authors have really done a highly commendable act of public service. I hope it has the intended effect of making Indian pharmaceuticals safer.
The book is not for all readers - only those who want a deep dive into the issues raised by the authors.
For those who want a higher-level understanding, someone needs to edit the book down to the key findings without necessarily the full burden of proof or the detailed historical context. Else one can simply skim read the lengthy book.
The authors have really done a highly commendable act of public service. I hope it has the intended effect of making Indian pharmaceuticals safer.
The book is not for all readers - only those who want a deep dive into the issues raised by the authors.
For those who want a higher-level understanding, someone needs to edit the book down to the key findings without necessarily the full burden of proof or the detailed historical context. Else one can simply skim read the lengthy book.
November 26, 2022
I hope that more and more Indian citizens read this to build civic discource to open up and clean this mess of substandard meds in India.. we can't be sitting on laws of 1940 and 1954 for drugs and cosmetics in the country which boasts of being the pharmacy of the world
Thanks to passionate souls like Dinesh Thakur to have taken this as a mission.
Thanks to passionate souls like Dinesh Thakur to have taken this as a mission.
April 4, 2023
Evidence based educative book, this is a must-read for all health professionals (physicians, pharmacists, pharma co employees, and everyone else) as well as for consumers of therapeutic drugs (which means all of us). The book is impactful because of the way critical knowledge is given in an easy to understand language.
October 4, 2023
keeping the world’s medicines safe
The US FDA does a great job keeping US drugs safe for consumers. In other countries, this may not be the case. This book is a great read if you are new to the subject.
The US FDA does a great job keeping US drugs safe for consumers. In other countries, this may not be the case. This book is a great read if you are new to the subject.
March 14, 2024
Astonishing exposure by Dinesh Thakur!! We always knew Indian Pharma is all Deceit, corruption , crooked..... only making money, lives can be damned! Thakur validates with evidences..!
It is more god's will we survive taking the Indian medicines rather than Pharma doing service for us!!
It is more god's will we survive taking the Indian medicines rather than Pharma doing service for us!!
March 18, 2023
A good book exposing basic flaws in drug regulations in India and their more flawed implementation .
May 16, 2023
would have rated higher if the authors did not sound like self righteous snots.
January 23, 2024
Truth is out!!!! Frightening and forces one to start living holistically... The situation is very bad
Read
March 3, 20253% I was in a different mood when I read bottle of lies
December 29, 2023
Pharma is such a weirdly overlooked sector. Tech is seen as sexy. So is finance. Food, entertainment, sports all of them are always in the news. But pharma manufacturing is seen as something as mundane as manufacturing plastic bags. Sure there are regulations, specialised education, etc But public perception of the sector is mostly something they feel they don’t need to bother about much. People just expect medicines to work. And aren’t really keen to know more about it or engage more on the subject. Sometimes there will be discussions about “traditional” medicine being better and pharna companies being evil… but there’s very little depth to those discussions and is mostly about personal anecdotes of how doctors were trying to force expensive medicines, or the horrendous side effects, whereas castor oil poured into the belly button eventually cured the ailing patient and had them hopping with joy.
The kind of issues plaguing Indian pharma company are different from the ways in which “big pharma” is evil. The root cause is mostly greed. But the manifestations of this greed are very different. And the tools for exploitation are poorly drafted laws, and people playing fast and loose with what laws might exist. The fundamental problem is the sheer apathy from government whose job it is to sort this stuff out. And it is apathy, not lack of will or anything. They literally “lost” a definitive report commissioned by the parliament, which actually laid out the problems and potential solutions. The authors of the book literally had to go and ask the person who had written the report in the first place.
The book starts with the history of regulation in india, from the pre-independence days. A teething problem was that “traditional” medicines like Ayurveda and Unami were never properly brought in the ambit of regulation. And even as they had courses for these formalised in colleges, the sector is rife with untested medicines, misleading advertising, and fear-mongering against clinically studied pharmaceuticals. And in 2023, almost 2024, today’s news headlines report that, the traditional “doctors”… the ones who roam the streets doling out ailments… formal recognition as doctors…
The issues with proper pharmaceutical regulation is discussed in detail. You will find horrific stories of how 25-30% of medicines in government hospitals are potentially not of standard quality (NSQ). Heck, the facilities to test medicines, the processes to test the factories manufacturing medicines… is all in shambles. Couple that with rife data faking practices… it’s basically a miracle we are such a populous country. I certainly have first hand experience of acid reflux medicines, branded ones, in india seem to have no discernible effect. Where’s ones I get in UK are extremely effective. Never really thought much about it till this book.
The book raises important questions. The efforts taken by the authors to an earth. The information through a stream of RTIs is tremendously impressive. And then presenting it in a reasonably reasonable form to the end readers is even more of a challenge. This is one of the rare books where it’s worthwhile to read the acknowledgements to understand the kind of effort, The authors and their rag-tag team had to take to write this book.
That said it is still a very dry book. It quotes from question and answer sessions in the parliament. It quotes from very formal reports in extensive measure, which does not make for easy reading. It even sidesteps are very obvious joke about asses when it describes people studying bums in colleges. Well, not bums, but BUMS(bachelor of unani medicines). Now that I think about it, the joke would be poorly placed, but you get my drift.
However, I do hope we as a society sit and take notice. US FDA is touted as a gold-standard, but there are plenty of people criticising their shortcomings. What we have in india, the complex internet-governmental gloop of acronyms for various state and central official bodies regulating Indian pharmaceutical bodies needs to be de-politicised and sorted out. The whole AyUsH spanner is only pouring more oil to the fire, especially with its very political agenda, and alarmingly unscientific, heck, even seemingly, blatantly mis-leading messaging. And it is truly important if we are serious about making sure india’s title of “pharmacy of the world” has to have any serious meaning to it.
The kind of issues plaguing Indian pharma company are different from the ways in which “big pharma” is evil. The root cause is mostly greed. But the manifestations of this greed are very different. And the tools for exploitation are poorly drafted laws, and people playing fast and loose with what laws might exist. The fundamental problem is the sheer apathy from government whose job it is to sort this stuff out. And it is apathy, not lack of will or anything. They literally “lost” a definitive report commissioned by the parliament, which actually laid out the problems and potential solutions. The authors of the book literally had to go and ask the person who had written the report in the first place.
The book starts with the history of regulation in india, from the pre-independence days. A teething problem was that “traditional” medicines like Ayurveda and Unami were never properly brought in the ambit of regulation. And even as they had courses for these formalised in colleges, the sector is rife with untested medicines, misleading advertising, and fear-mongering against clinically studied pharmaceuticals. And in 2023, almost 2024, today’s news headlines report that, the traditional “doctors”… the ones who roam the streets doling out ailments… formal recognition as doctors…
The issues with proper pharmaceutical regulation is discussed in detail. You will find horrific stories of how 25-30% of medicines in government hospitals are potentially not of standard quality (NSQ). Heck, the facilities to test medicines, the processes to test the factories manufacturing medicines… is all in shambles. Couple that with rife data faking practices… it’s basically a miracle we are such a populous country. I certainly have first hand experience of acid reflux medicines, branded ones, in india seem to have no discernible effect. Where’s ones I get in UK are extremely effective. Never really thought much about it till this book.
The book raises important questions. The efforts taken by the authors to an earth. The information through a stream of RTIs is tremendously impressive. And then presenting it in a reasonably reasonable form to the end readers is even more of a challenge. This is one of the rare books where it’s worthwhile to read the acknowledgements to understand the kind of effort, The authors and their rag-tag team had to take to write this book.
That said it is still a very dry book. It quotes from question and answer sessions in the parliament. It quotes from very formal reports in extensive measure, which does not make for easy reading. It even sidesteps are very obvious joke about asses when it describes people studying bums in colleges. Well, not bums, but BUMS(bachelor of unani medicines). Now that I think about it, the joke would be poorly placed, but you get my drift.
However, I do hope we as a society sit and take notice. US FDA is touted as a gold-standard, but there are plenty of people criticising their shortcomings. What we have in india, the complex internet-governmental gloop of acronyms for various state and central official bodies regulating Indian pharmaceutical bodies needs to be de-politicised and sorted out. The whole AyUsH spanner is only pouring more oil to the fire, especially with its very political agenda, and alarmingly unscientific, heck, even seemingly, blatantly mis-leading messaging. And it is truly important if we are serious about making sure india’s title of “pharmacy of the world” has to have any serious meaning to it.
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