Any time would be a good time to evaluate the drug regulatory framework in a country and fix it. And this is being witnessed in different countries. For example, the questions posed by the scientific community on the Covid-19 vaccines.
In fact, drug regulatory systems across the world have constantly learnt and evolved from incidents resulting from bad medicine or ineffective regulatory systems. A recent book, The Truth Pill: The Myth of Drug Regulation in India, maps such regulatory evolutions across the US and Europe, for instance, 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 incidents in India, involving adulterated cough syrups containing the notorious DEG (diethylene glycol).
Often, in the narration of medicine-linked tragic incidents, the silent heroes involved in the good fight for quality medicine are lost in the din. But the story of good drug regulatory practices has its heroes, and the book spotlights them.
Silent heroes
Frances Oldam Kelsey, for instance, is respected as “one of the most significant personalities in the history of the USFDA (US Food and Drug Administration)” for her vigilant role in questioning the marketing application from the makers of Thalidomide, for want of more safety-related data. In fact, the book quotes from her obituary in The New York Times, when she passed at 101 years, recognising her role in the Thalidomide case, “celebrated not only for her vigilance, which spared the US from widespread birth deformities, but also for giving rise to modern laws regulating pharmaceuticals.” The “silent heroes” of the Thalidomide episode were the policy makers who amended the American regulatory law in 1938 to mandate the submission of safety data as one of the conditions for approving new drugs in the US, the book noted.
Closer home, there’s Justice Lentin of the Bombay High Court, who headed the Commission of Inquiry, following the death of 14 patients at Mumbai’s JJ Hospital, from DEG poisoning (1986). To begin with, the book notes, “Justice Lentin held rigorous, marathon hearings in an open courtroom, something that is seldom seen today.”
And justifying the public inquiry, Justice Lentin said: “Secrecy breeds suspicion, and suspicion breeds contempt. A public inquiry would therefore ensure public confidence in the work of the commission to arrive at the truth without fear or favour, regardless of power, position, influence and importance of witnesses.” Truer words could not have been said, even today.
The Commission’s report was out in less than a year, holding those in power accountable, including a joint commissioner in the Maharashtra Food and Drug Administration and the State Health Minister. And, significantly, the State government endorsed 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, coming as it did at a time when social media and similar echo-chambers did not exist to publicise it.
Need for transparency
The latest book documents several industry and regulatory problems in dire need of fixing - across manufacturing and clinical trials; ranging from non-standard quality drugs to DEG in syrups..
But it faces the danger of falling into the binary or being with the system or against it, in this case the latter. And that could take away from insights that do, in fact, come through.
The repetitive nature of industry/ regulatory transgressions – across geographies and time, come through in the book - signalling hope that loopholes can be identified and plugged. The book points to the constantly evolving and innovating pharmaceutical industry and the need for a regularly upgraded regulatory system, armed with qualified personnel. No disagreement on that, nor on the need for greater transparency in the regulatory processes.
The book, however, wades into discussing regulatory oversight for traditional medicine. While there is need for better governance in these systems of medicine, it should be left to subject experts with knowledge of genuine traditional medicine and its regulatory requirements. Else, it runs the risk of using the wrong yardstick to assess these systems, besides getting distracted with politics, religion and other wellness-linked marketing campaigns and personalities.
The Truth Pill is written by once industry-insider Dinesh S Thakur, who turned whistleblower against the erstwhile Ranbaxy. He is also founder and president of the Thakur Family Foundation, described as a philanthropic organisation that provides grants to public health research and health journalism in India. Co-author, lawyer Prashant Reddy T, after a stint with law-firms and litigation, advises Thakur’s campaign for drug regulatory reform.
Check out the book on Amazon here
About the book:
The Truth pill: The Myth of Drug Regulation in India
Publisher: Simon & Schuster
Pages: 512 Price: Rs 899