Dinesh S Thakur & Prashant Reddy T' s 'The Truth Pill': Exposing underbelly of pharma business

Dinesh C Sharma

The recent tragedy of 69 children dying due to acute kidney failure in Gambia has caught public attention in India and elsewhere. The culprit behind this ghastly episode is suspected to be a set of cough syrups manufactured by a company based in Haryana. Laboratory tests done by the World Health Organisation revealed that the samples of the cough medicine had high levels of two toxic industrial solvents. The contamination of cough syrups with the same chemical has killed children in India too. The most recent case was in 2020 at Ramnagar in J&K. The death of five patients due to allegedly spurious anaesthesia at the PGI in Chandigarh in September is another shocking case. Such episodes get highlighted because of the number of deaths they cause, but adulteration and contamination of drugs is a major problem that goes unnoticed most of the time.

At the crux of all this is the Drugs and Cosmetics Act of 1940 — the legislation for regulation of the manufacture, sale and marketing of drugs in the country. The law has been amended a few times, and several rules and regulations have been framed from time to time, yet the menace of substandard and adulterated drugs continues. Why this is so? ‘The Truth Pill’ by Dinesh S Thakur and Prashant Reddy T dwells on this vital question.

Both the authors are well placed to address this question as they have been deeply involved with the issue — Thakur as a whistleblower and Reddy as a lawyer specialising in intellectual property law. Thakur used to work with Ranbaxy but turned a whistleblower when he found the company was indulging in data falsification to get regulatory approvals for its drugs meant for export. This resulted in the company pleading guilty in American courts in 2013 and coughing up a massive penalty of 500 million dollars. Since then, Thakur has been advocating reform in the drug regulatory system in India.

Through a series of case studies, publicly available data and information culled through hundreds of RTI applications in recent years, the authors expose the holes in the regulatory system, weak and ineffective enforcement of the law, leniency shown by courts and the political interference to shield the industry.

Drug inspectors in states are supposed to collect samples from the market, send them for testing and initiate action if they are found to be not of standard quality. The number of samples collected and found sub-standard varies from state to state, but it is generally very low and action taken is almost nil. Faulty batches of medicines are not recalled. Companies are expected to follow Good Manufacturing Practices (GMP) but the book points out that violation of GMP guidelines is not considered an offence under Indian law. The result of all this mess is that erring manufacturers are barely prosecuted and punished, and they keep committing the same offences again and again. Despite regulators of several countries pointing to sub-standard drugs exported by Indian companies, Indian regulators and the government turn a blind eye.

The book also deals with regulatory processes related to the approval of new drugs. Here it cites the report of the Parliamentary Standing Committee on Health, which in 2012 extensively investigated the functioning of the Central Drugs Standard Control Organisation (CDSCO). The report found widespread violation of rules in the approval of new drugs as well as fixed dose combinations. But the government and the regulator did little to set the house in order. The report of an expert committee set up to investigate suspicious drug approvals mentioned in the parliamentary panel was suppressed and never made public. On the highly contentious and politically-surcharged issue of regulating Ayurveda and other traditional systems of medicine, the authors note that the regulatory framework for such systems has no requirement to prove the safety and efficacy of these drugs.

This is well-researched documentation of the state of India’s drug regulatory system. The central message is that India needs a transparent, responsive and honest regulatory system because the safety of drugs is directly linked to people’s lives. It is a bulky book, so the absence of an index is quite perplexing. The text could have been better organised and edited tightly to make it more accessible to general readers. Since both authors are activists, the bias in the language used is obvious. Nevertheless, it is a timely book and a wake-up call for all those interested in the well-being of Indian citizens and anyone in the world using these drugs.

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