Book sheds light on burning questions about drug regulation in India

As the WHO says cough syrups made by an Indian company could potentially be linked to the deaths of 66 children in The Gambia, a soon-to-be-published book sheds light on burning issues around drug regulation in the world. countries and raises crucial questions.

”The Truth Pill: The Myth of Drug Regulation in India” by Ranbaxy whistleblower Dinesh Singh Thakur and lawyer Prashant Reddy Thikkavarapu analyzes the actions of institutions responsible for the safety and efficiency of drug supply Indians in the context of the historical development of the Drugs Act, 1940 from pre-independence India to the present day. Adulterated drugs are a recurring problem in the Indian pharmaceutical industry due to its failure to adhere to basic Good Manufacturing Practices (GMP). As the authors document in their book, published by Simon & Schuster India, India’s pharmaceutical industry has had a long history of DEG poisoning, with the first occurrence reported in 1972 in Madras. This was followed by 4 more DEG poisonings, the most recent being in 2020 when 11 children from Jammu died at PGIMER, Chandigarh where they had been taken for treatment. The reason such poisoning events occur is because many pharmaceutical companies in India do not test all excipients before they are used in drug manufacturing, despite the GMP code expressly requiring such testing, says the book. When pharmaceutical companies buy propylene glycol to use in making cough syrups, they must test for contamination because DEG adulteration has been a known problem since 1937, when the first mass DEG poisoning in the United States killed over 100 adults and children. The United States managed to prevent any repeat incidents, but why did India fail? The answer, as the authors pointed out in their book, lies in systemic failures at all levels of India’s drug regulatory framework. Yet legislation recently drafted to replace the colonial-era Drugs and Cosmetics Act of 1940 does little to address these systemic problems. This resistance to reform is largely explained by the fact that the regulatory apparatus in India has been “captured” by the pharmaceutical industry which has always put profits before patients. Since 2004, when the fraud at the pharmaceutical company Ranbaxy was first revealed, the Indian pharmaceutical industry and clinical research organizations have been rocked by a series of scandals after investigations by US and European regulators medication.

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Angela C. Hale