The Truth Pill: The Myth of Drug Regulation in India
Authors
  • Dinesh Singh Thakur
  • Prashant Reddy Thikkavarapu
CountryIndia
LanguageEnglish
Subjects
GenreNonfiction
PublisherSimon & Schuster India
Publication date
10 October 2022
Media typePrint (hardback), Digital
Pages508
ISBN9789392099175
Websitethetruthpill.in

The Truth Pill: The Myth of Drug Regulation in India is a 2022 book by whistleblower Dinesh Thakur and lawyer Prashant Reddy. The book highlights the problems in India's drug regulatory framework, and the government oversight relating to poor manufacturing practices and clinical trials of drugs by Indian pharmaceutical companies.[1]

The authors advocate for greater transparency and reforms in India's drug regulation and enforcement system.[1]

Context

In 2007, U.S. Food and Drug Administration, had begun criminal investigation of Ranbaxy Laboratories after whistleblowers including Dinesh Thakur, informed the FDA of serious quality-related issues at the company.[2] By 25 February 2009, the FDA said it had halted reviews of all drug applications from India, because of a practice of falsification of data and test results in approved and pending drug applications.[3] In May 2013, Ranbaxy pleaded guilty and paid US$500 million in fines for felony charges relating to the manufacture and distribution of adulterated drugs and misrepresenting clinical generic drug data.[4][5]

Summary

The book details and analyses several incidents of deaths, occurred due to malpractices by Indian pharmaceutical companies and the judicial laxity in such cases.[6] One of the incidents being the death of 12 children in Jammu & Kashmir, due to consumption of a cough syrup containing diethylene glycol.[7]

The book also critiques the practice of Ayurveda in India. Authors argue that Ayurvedic cures, unlike modern medicine, can be administered in India without the prescription of a qualified doctor and Ayurvedic medicines are known to contain harmful heavy metals.[8] They also raise concern that the regulatory framework for Ayurvedic and other traditional medicine, contains no requirement to prove its safety and efficacy.[9]

Aftermath

Reddy and Thakur received a legal notice from Central Drugs Standard Control Organisation after they commented on the deaths of more than 66 children in Gambia, caused due to Indian-made cough syrups. The deaths had occurred after the release of their book. CDSCO accused the authors of trying to malign the image of the institution and the nation.[10][11]

See also

References

  1. 1 2 Jyothi Datta (25 November 2022). "Book review: The Truth pill: The Myth of Drug Regulation in India". Business Line. Retrieved 13 December 2022.
  2. ↑ Dinesh S Thakur; Prashant Reddy Thikkavarapu (17 October 2022). "India must act on drug adulteration – lives around the world are at stake". The Guardian. Retrieved 13 December 2022.
  3. ↑ "FDA Takes New Regulatory Action Against Ranbaxy's Paonta Sahib plant in India. Agency halts review of drug applications from plant due to evidence of falsified data; invokes Application Integrity Policy". Press Announcement. Food and Drug Administration. 25 February 2009. Retrieved 1 June 2013.
  4. ↑ "India drug firm pays record US fine". BBC News. 2013-05-14. Retrieved 2018-01-03.
  5. ↑ Lambert, Jonathan (12 May 2019). "'Bottle Of Lies' Exposes The Dark Side Of The Generic-Drug Boom". NPR.org. Retrieved 2020-11-17.
  6. ↑ Katherine Eban (10 December 2022). "'The Truth Pill': A man's lonely fight against the poorly regulated Indian pharmaceutical industry". Scroll.in. Retrieved 13 December 2022.
  7. ↑ "J&K: No Chargesheet Even 3 Years After 12 Children Died After Consuming Cough Syrup". The Wire. 28 November 2022. Retrieved 13 December 2022.
  8. ↑ Arunima Mazumdar (12 November 2022). "Review: The Truth Pill; The Myth of Drugs Regulation in India byDinesh S Thakur and Prashant Reddy T". Hindustan Times. Retrieved 13 December 2022.
  9. ↑ Dinesh C Sharma (23 October 2022). "Dinesh S Thakur & Prashant Reddy T' s 'The Truth Pill': Exposing underbelly of pharma business". The Tribune. Retrieved 13 December 2022.
  10. ↑ Ashwine Kumar Singh (26 October 2022). "Cough syrup deaths: Why is India's drug regulator going after Dinesh Thakur and T Prashant Reddy?". Newslaundry. Retrieved 13 December 2022.
  11. ↑ G.S. Mudur (18 October 2022). "Suit threat against activist, lawyer for questioning CDSCO's role in Gambia deaths". The Telegraph. Retrieved 13 December 2022.
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