Suruchi Kumari is a third-year LL.B. student at the Campus Law Centre, Faculty of Law, University of Delhi, with a bachelor’s degree from Miranda House, University of Delhi. Read More
Abstract
The book revolves around the poor drug regulation in India and its effects. The Indian regulators have permitted the sale of medicines that have never been approved by regulators in developed countries markets due to dubious drug approval process. India is experiencing twin crises in both domestic and export markets due to either out-of-date rules or none at all in some areas. The review will assess the writers’ point of view and the way writers’ try to disseminate the message to connect with the readers.
Keywords – Drugs, regulation, manufacturing, pharmacy ,industries
Dinesh S. Thakur and Prashant Reddy’s book “The Truth Pill is full of harsh“ realities regarding India’s drug regulatory system, which forces decision-makers to reflect.
The Truth Pill is one of the most insightful and authoritative works on the composition of drug regulations in India to be published in recent years, which reveals poor drug regulation in India. There are eleven chapters in the book “The Truth Pill: The Myth of Drug Regulation in India.” An Epidemic of Diethylene Glycol Poisoning (DEG) and Regulatory Failure is the prologue of the book. This is true even though Indian law mandates Good Manufacturing Practices (GMP), which provide for the testing of final formulations before market release and raw materials prior to usage in production. The author also discusses the mass poisoning episode that occurred in Jammu. A total of 11 children died due to renal failure as a result of DEG poisoning. The maker of the allegedly contaminated cough is under the control of the Himachal Pradesh Drug Control Administration (HPDCA).According to the authors, such cases are well documented, even this incident, and it was preventable, shedding light on a faulty drug regulation system.
Digital Vision contended before the Himachal Pradesh High Court that it lacked the necessary facilities to test the information. According to the authors, if such an allegation is true, HPDCA failed to check such a lack of facilities in the past inspection. It says when, in 1986, 14 patients died at the J.J. hospital due to DEG poisoning, Justice Lenin was appointed by then chief minister of Maharashtra. In less than a year, a report of around 300 pages was produced, which held the joint commissioner of Maharashtra food and drug administration along with the health minister of the state liable.
Chapter one
Chapter one has the title “The Birth of Modern Medicine and Drug Regulation.” It begins with medicine theory being replaced by cell theory and germ theory, which proved to be a breakthrough. The authors go on to explain the development of modern medicines, which led to the development of the modern pharmaceutical industry and drug regulation. The authors delve into changes that occurred in regulation throughout history. The regulatory frameworks in Germany and France were revolutionary because they guaranteed, maybe for the first time ever, a guarantee from the government about the quality of a medicine that was being given to patients. The first mass drug-related deaths occurred when 13 children in Camden, Missouri, and St. Louis, Missouri, died. This served as a warning that these new, life-saving medications may be harmful if they are not produced and tested correctly in fully sterile facilities. Four years after the sulfanilamide disaster happened in 1941, another tragedy happened due to poor manufacturing practices in American pharmaceutical industries, which led to 300 deaths. This led to the beginning of modern good manufacturing practices. The author makes the claim that fatalities will occur in nations whose drug laws are not properly draughted and implemented. It is untrustworthy for the pharmaceutical business to self-regulate.
Second chapter
The second chapter is called “Controlling the Craze for Medicinal Drugs in Colonial India.” This chapter talks about the introduction of an act related to drug regulation for the first time. Authors point out that one of the earliest public debates in India for the regulation of manufacture and sale of medicines was brought when Haroon Jaffer, a legislator from the Bombay Presidency, moved a resolution titled “Control of the Craze of Medicinal Drugs.” The Drug Bill 1937 was introduced, which was later rejected by the selection committee. However, the government of India came up with a new strategy to introduce uniform legislation all over British India. The Drug Act of 1940 was passed, which led to setting up pharmaceutical standards; however, the authors say, the issues that were raised by Sir Jaffer‘s motion were not included in the law, and some of them continued to persist even after centuries.
Third chapter
The third chapter name is “Of Botched Investigations, Dodgy Prosecution Guidelines, and Lenient Judges.” In this chapter, the medications designated as “Not of Standard Quality (NSQ)” have been the subject of much debate by the authors. The chapter begins with one instance, which happened in 2016: four management executives of Alfred Berg and Co. made an appearance before a metropolitan magistrate in Sadiapat, Chennai, where they entered guilty pleas in support of the prosecution. As of March 2022, the lawsuit had not yet gone to trial after being filed in 2014. The company could not be served with a summons by the Gudiyattam court. The authors rightly state how lenient the Indian courts are when it comes to conviction against pharmaceutical manufacturers; despite having various loopholes, the company gets away with a fine or delay in action. The authors highlight that there has been a lack of investigation by the drug inspector.
Fourth chapter
The fourth chapter is “Of Glass Particles and Bacterial Endotoxins in Drugs” explains that for most drugs that come under NSQ, it is because either they have failed in assay and dissolution tests or they have unidentified/bacterial particulate matter. However, glass particles are also one of the reasons. The author lists the Indian Drug Regulatory Machinery’s historical emphasis on monitoring and evaluating the quality of medications provided in the market as one of the most plausible explanations for Indian pharmaceutical businesses’ disregard for Good Manufacturing Practices (GMP) compliance in India. It can be avoided that many states lack the well-equipped lab space and the analysts needed to do a complete pharmacopeial examination on samples that drug inspectors get from the marketplace that authors claim. The authors emphasise in their concluding paragraph of the chapter that state laboratories must perform a crucial test known as “impurity testing.” The authors say that any significant study is hampered by the lack of organisation in even the data that is provided on the XLN website and the inconsistent cataloguing of data. The authors have concluded by saying that a straightforward change is required to allow drug regulators to provide the public with more information and that this information should be made available on a platform in an orderly fashion.
Fifth chapter
The fifth chapter name is” New Drugs and “the Persistent Insolence of the CDSCO…” According to the writers, the Fifty-Ninth Report on the Operation of the Central Drugs Standards Control Organisation, which was released in 2012, was a historic event in the history of drug control that highlighted the deep concern and was different from previous reports. It is disheartening to see that despite highlighting such issues in such a credible report, there has been a lack of action towards the regulation of drugs. This chapter underlines the fact that evidence-based medicine is nonexistent in India. It seems that individual Indian physicians have been working to disseminate the concepts of evidence-based medicine; there doesn’t seem to be an institutional push for these ideas.
Sixth chapter
In the sixth chapter, “Can “Made in India” Generic Medicine Be Trusted?” the authors suggest that all medications sold in India should have a label stating whether or not the medication has successfully undergone stability and bioequivalency testing. In addition to requiring public disclosure, this kind of labelling regulation will provide doctors with the information they need to choose which formulations are reliable for themselves. It seems that The Truth Pill can be assumed to be a sequel to Katherine Eban’s previous book Bottle of Lies. The book reaffirms the key ideas of Eban’s outstanding work, which include inadequate production standards and quality control as well as careless regulators in the pharmaceutical sector, particularly if we refer to Chapter 6 of the book.
Seventh chapter
In the seventh chapter titled “The Losing Battle to Regulate Traditional Indian Medicine,” the author highlights Ayurvedic medicines have a lack of scientific support and there has been difficulty in regulating Ayurvedic medicines due to resistance from practitioners and the unknown composition of Ayurvedic medicines. It emphasizes on the fact that when an Ayurvedic product shows promise in treating or curing an illness, it should be subjected to the same regulatory processes as new drugs, which include a thorough three-phase, double-blind randomized controlled trial (RCT) to determine its safety and effectiveness. There will undoubtedly be strong opposition to imposing this rule on all Unani and Ayurvedic goods, particularly from the Ayurvedic sector.
Eighth chapter
In the eighth chapter, “The Dangers Posed by Traditional Medicine and its Practitioners to Public Health,” the chapter says that the danger arises due to a lack of credible regulatory framework for traditional medicines not only from practitioners/manufacturers but also from research centres for traditional medicines. The authors delve into research funded by the government over the years and its deadly effects on public health, highlighting that Ayurvedic medicines contain heavy metals. The authors state that Ayurvedic practitioners sometimes go beyond bounderies and prescribe modern medicines. Governing the field of traditional medicine, despite the fact that it is an arduous undertaking, there is no other course of action considering the threat to public health, according to the author.
Ninth chapter
In the ninth chapter, “The Chaos of Indian Pharmacies and their Supply Chains,” the Ministry of Health needs to give careful thought to seizing this chance to significantly improve the present minimum license criteria for starting and operating a pharmacy or participating in whole-sale medication. The author concludes the chapter by saying that the Ministry of Health has never had a better opportunity to reevaluate pharmacy regulations in a way that will ensure better drug storage during distribution and transit, prevent prescription abuse, and maintain supply chain integrity.
Tenth chapter
In the tenth chapter, “ Of Drug Advertisements, Promotions, and Trademarks,” the chapter gives an instance in which the Supreme Court considered a case in 1975 about advertising for a scientific and electric therapy machine that was published in the Hindi daily Sanmarg. The machine was intended to heal a variety of ailments, including weakness, lethargy, and early ageing. The Supreme Court maintained the conviction and the $100/- penalty imposed by the lower courts. In a similar vein, the Madras High Court declined to halt the drug inspector’s probe in 1990. In the case in question, an advertisement for a Durka Ayurveda tumbler appeared in the Tamil weekly “Kalkanadu.” It claimed that drinking water from the tumbler may reduce blood pressure, diabetes, weakness, and other conditions. The authors also state at the end of that chapter that rules requiring pharmaceutical companies to submit all promotional literature, brand names, and advertisements to the national drug regulator for approval prior to disseminating them to the public would result in a more effective regulatory framework. In order to adequately filter all of this material from the standpoint of public health, the drug regulator would need to establish internal capability.
Eleventh chapter
In the eleventh chapter, “The Politics and Levers of Reforming India’s Drug Regulatory Framework,” the authors note that the middle class’s demands for change in India often start with the filing of public interest lawsuits before the Supreme Court.
After going through the book, it can be concluded that the book’s emphasis is on two things—in-depth research and proactive RTI applications, is one of its underappreciated advantages. As a result, it can give a decent overview of all the issues with India’s healthcare system. Though the book offers great reform suggestions, it also explains why it is not realistic to expect things to improve very soon. One wishes this was not the case. Admittedly, we found it hard to accept that things actually were as horrible as the book portrays them. One of us looked through all of the cases that were reported to the Supreme Court and the High Courts to see whether there were any examples where the statutory minimum sentence was given. The outcome shouldn’t have surprised us because Dinesh Thakur and Prashant Reddy had done extensive research. The writers found it difficult to obtain information from government officials, and it also takes a great deal of patience. Because of this, the author challenges the readers to reconsider drug regulatory law from a pragmatic standpoint. The book raises important issues regarding India and Indians in general: there is no gain in following the law. However there is a huge gain in breaking the law in order to profit. There is no risk of punishment for breaking the law, and the state, whose primary goal is to protect the people, is complicit in the crime. It reveals the negative effects of bureaucratic delays on medication regulations, including the resolution of investigations, violations of quality standards, and supply chain breakdowns
This book, which reveals the toughest simple realities to keep you on your toes, equitably covers legally bound and medically conflicting aspects in a clear and linear literary style that makes it accessible to the typical reader to understand the gravity even better.
