The Truth Pill: The Myth of Drug Regulation in India
About this ebook
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These twin crises, in both the domestic and export markets, is because India has either outdated regulations or no regulations in some areas. Even the outdated regulations are enforced with kids gloves by drug inspectors and judicial magistrates who are ready to forgive even those whose drugs are found to contain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.
Ratings and reviews
- Flag inappropriate
- Flag inappropriate
- Flag inappropriate
About the author
Dinesh Singh Thakur is a trained chemical engineer. He turned whistleblower against Ranbaxy after witnessing large-scale data fraud at the company. His efforts led to Ranbaxy pleading guilty to violating American law before an American court in 2013. The company agreed to pay a penalty of $500 million dollars as a part of its guilty plea. For his actions, he received the Joe A. Callaway Award for Civic Courage and the ACFE Cliff Robertson Sentinel Award. Since 2014, he has advocated for reform of India’s colonial-era Drugs & Cosmetics Act, 1940 and has founded an advocacy group called the Citizens for Affordable, Safe & Effective Medicine (CASEM). He is also the founder and President of the Thakur Family Foundation, a philanthropic organisation that provides grants for research on public health and health journalism in India.
Prashant Reddy Thikkavarapu studied law at the National Law School of India University and Stanford Law School. He has worked in law firms as well as in academia in India and Singapore. This includes stints at the National Academy for Legal Studies & Research (NALSAR) and the School of Law, Singapore Management University. He has written extensively on intellectual property law, regulation of the pharmaceutical industry and judicial reforms in India. He is also the co-author of Create, Copy, Disrupt: India’s Intellectual Property Dilemmas (Oxford University Press) and The Truth Pill: The Myth of Drug Regulation in India (Simon & Schuster).
