THE TRUTH PILL book review

Bitter medicine for pharma regulation – The Truth Pill: The Myth of Drug Regulation in India

In October, the World Health Organization reported that the deaths of 66 children due to acute kidney failure in The Gambia were potentially linked to four brands of cough syrup manufactured by Maiden Pharmaceuticals in Haryana. The deaths occurred over a period of months and after testing in September, WHO laboratory analysis found unacceptable amounts of diethylene glycol and ethylene glycol in the products.

A medical alert was issued on 29 September after the Central Drugs Standard Control Organization was informed. An inspection of the manufacturing facility found defects and halted production. Several statements were made on whether it is the responsibility of the Center or the State to allow manufacture and/or export, and the WHO process was questioned. Within weeks this news was not on the front page.

The Truth Pill: The Myth of Drug Regulation in India – Review

The book points to the ever-evolving and innovative pharmaceutical industry and the need for a regularly upgraded regulatory system manned by qualified personnel.

Any time would be a good time to evaluate and fine-tune the drug regulatory framework in a country. And this is being seen in different countries. For example, questions asked by the scientific community on COVID-19 vaccines.

Indeed, drug regulatory systems around the world have continually learned and evolved from incidents resulting from bad drugs or ineffective regulatory systems. A recent book, The Truth Pill: The Myth of Drug Regulation in India, for example, maps out such regulatory developments in the US and Europe, making a strong case for the Indian drug regulatory system to do the same. A case further underscored by the disturbing overlap of past and present events in India involving adulterated cough syrups containing the infamous DEG (diethylene glycol).

Too often, in narratives of tragic events involving medicine, the silent heroes involved in the good fight for quality medicine are lost in the commotion. But the story of good drug regulatory practices has its heroes, and the book exposes them.

Silent hero
For example, Francis Oldham Kelsey is hailed as “one of the most important personalities in the history of the USFDA (US Food and Drug Administration)” because of his vigilante role in questioning the marketing application from the makers of thalidomide. want more for. Security related data. In fact, the book quotes from her obituary in The New York Times, when she turned 101, recognizing her role in the thalidomide case, “not only celebrated for her vigilance, which saved America from widespread birth defects but also for giving rise to modern laws regulating pharmaceuticals. The “silent hero” of the thalidomide episode was the policy maker who amended US regulatory law in 1938 to make it one of the conditions for approving new drugs in the US. Submission of security data in the form of a mandatory

Bombay High Court Justice Lentin, who headed the commission of inquiry following the death of 14 patients from DEG poisoning (1986) at Mumbai’s JJ Hospital. To begin with, the book notes, “Justice Lentin conducted a rigorous, marathon hearing in an open courtroom rarely seen today.”

And justifying the public inquiry, Justice Lentin said: “Secretity breeds suspicion, and suspicion breeds contempt. Hence the public confidence in the work of a public inquiry commission without fear or favour, would ensure to reach the truth regardless of the power, position, influence and importance of witnesses. True words could not have been spoken even today.

The commission’s report came less than a year ago, holding those in power accountable, including a joint commissioner in the Maharashtra Food and Drug Administration and the state’s health minister. And, remarkably, the state government supported the points made in the report.

While these details may be known in regulatory, journalistic or civil society circles – Justice Lentin’s stellar report bears repetition and amplification, because it came at a time when social media and similar echo chambers did not exist to propagate it. Were.

Need for transparency

The latest book lays out a number of industry and regulatory problems desperately needed to be fixed – in manufacturing and clinical trials; From non-standard quality medicines to DEG in syrup…

But it faces the danger of falling into a binary or of being with or against the system, in this case the latter. And it can take away from the insights that really come.

The repetitive nature of the industry/regulatory breaches – across geographies and times, come through the book – prompts an expectation that loopholes can be identified and plugged. The book points to the ever-evolving and innovative pharmaceutical industry and the need for a regularly upgraded regulatory system manned by qualified personnel. There is no disagreement on that, nor is there a need for more transparency in regulatory processes.

However, the book discusses regulatory oversight for traditional medicine. While there is a need for better governance in these systems of medicine, this should be left to subject matter experts with knowledge of actual traditional medicine and its regulatory requirements. Otherwise, it runs the risk of using the wrong criteria to assess these systems, in addition to being distracted by marketing campaigns and personas associated with politics, religion and other welfare.

The Truth Pill is authored by Dinesh S Thakur, a one-time industry insider who turned whistleblower against the then Ranbaxy. He is also the founder and chairman of the Thakur Family Foundation, described as a philanthropic organization that provides grants to public health research and health journalism in India. The co-author, lawyer Prashant Reddy T, advises Thakur’s campaign for drug regulatory reform, after a stint with law firms and litigation.

about the book:

The Truth Pill: The Myth of Drug Regulation in India

Publisher: Simon & Schuster

News Source – thehindubusinessline

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