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{{Short description|2022 book by Dinesh Thakur and Prashant Reddy}}
{{Infobox book
| image = File:Truth-pill-9789392099175 lg.jpg
| name = The Truth Pill: The Myth of Drug Regulation in India
| authors = {{unbulleted list|Dinesh Singh Thakur|Prashant Reddy Thikkavarapu|class=nowrap}}
| country = India
| language = English
| subjects = {{unbulleted list| [[Bioethics]] | [[Drug policy]] | [[Health law]] }}
| genre = Nonfiction
| publisher = [[Simon & Schuster]] India
| pub_date = 10 October 2022
| media_type = Print ([[hardback]]), Digital
| pages = 508
| isbn = 9789392099175
| website = {{URL|https://thetruthpill.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.<ref name="BL">{{cite web |author1=Jyothi Datta |title=Book review: The Truth pill: The Myth of Drug Regulation in India |url=https://www.thehindubusinessline.com/books/book-review-the-truth-pill-the-myth-of-drug-regulation-in-india/article66182899.ece |publisher=[[Business Line]] |access-date=13 December 2022 |date=25 November 2022}}</ref>

The authors advocate for greater transparency and reforms in India's drug regulation and enforcement system.<ref name="BL"/>

== Context ==
In 2007, the U.S. [[Food and Drug Administration]], had begun criminal investigation of [[Ranbaxy_Laboratories#Controversies|Ranbaxy Laboratories]] after whistleblowers including Dinesh Thakur informed the FDA of serious quality-related issues at the company.<ref name="guardian">{{cite web |author1=Dinesh S Thakur |author2=Prashant Reddy Thikkavarapu |title=India must act on drug adulteration – lives around the world are at stake |url=https://www.theguardian.com/global-development/2022/oct/17/india-drug-adulteration-manufacturing-standards |work=[[The Guardian]] |access-date=13 December 2022 |date=17 October 2022}}</ref> 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.<ref>{{cite news | title = 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 | date = 25 February 2009 | publisher = [[Food and Drug Administration]] | url = https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149532.htm | archive-url = https://web.archive.org/web/20100112090329/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149532.htm | url-status = dead | archive-date = January 12, 2010 | work = Press Announcement | access-date = 1 June 2013}}</ref> In May 2013, Ranbaxy pleaded guilty and paid {{US$|500}}{{nbsp}}million in fines for felony charges relating to the manufacture and distribution of adulterated drugs and misrepresenting clinical generic drug data.<ref>{{Cite web |url=https://www.bbc.com/news/world-asia-india-22520953 |title=India drug firm pays record US fine |date=2013-05-14 |website=BBC News |language=en-GB |access-date=2018-01-03}}</ref><ref>{{Cite news|title='Bottle Of Lies' Exposes The Dark Side Of The Generic-Drug Boom|url=https://www.npr.org/sections/health-shots/2019/05/12/722216512/bottle-of-lies-exposes-the-dark-side-of-the-generic-drug-boom|access-date=2020-11-17|website=NPR.org|date=12 May 2019|language=en|last1=Lambert|first1=Jonathan}}</ref>

== Summary ==
The book details and analyses several incidents of deaths having occurred due to malpractices by Indian pharmaceutical companies, and the judicial laxity in such cases.<ref name="scroll">{{cite web |author1=[[Katherine Eban]] |title='The Truth Pill': A man's lonely fight against the poorly regulated Indian pharmaceutical industry |url=https://scroll.in/article/1039303/the-truth-pill-a-mans-lonely-fight-against-the-poorly-regulated-indian-pharmaceutical-industry |publisher=[[Scroll.in]] |access-date=13 December 2022 |date=10 December 2022}}</ref> One of these incidents details the death of 12 children in [[Jammu and Kashmir (union territory)| Jammu and Kashmir]] due to consumption of a cough syrup containing [[diethylene glycol]].<ref name="wire">{{cite web |title=J&K: No Chargesheet Even 3 Years After 12 Children Died After Consuming Cough Syrup |url=https://thewire.in/rights/jk-no-chargesheet-even-3-years-after-12-children-died-after-consuming-cough-syrup |publisher=[[The Wire (India)|The Wire]] |access-date=13 December 2022 |date=28 November 2022}}</ref>

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.<ref name="HT">{{cite web |author1=Arunima Mazumdar |title=Review: The Truth Pill; The Myth of Drugs Regulation in India byDinesh S Thakur and Prashant Reddy T |url=https://www.hindustantimes.com/books/review-the-truth-pill-the-myth-of-drugs-regulation-in-india-bydinesh-s-thakur-and-prashant-reddy-t-101668184185862.html |publisher=[[Hindustan Times]] |access-date=13 December 2022 |date=12 November 2022}}</ref> They also raise concern that the regulatory framework for ''Ayurvedic'' and other traditional medicine contains no requirement to prove its safety and efficacy.<ref name="tribune">{{cite web |author1=Dinesh C Sharma |title=Dinesh S Thakur & Prashant Reddy T' s 'The Truth Pill': Exposing underbelly of pharma business |url=https://www.tribuneindia.com/news/reviews/story/dinesh-s-thakur-prashant-reddy-t-s-the-truth-pill-exposing-underbelly-of-pharma-business-444015 |publisher=[[The Tribune (Chandigarh)| The Tribune]] |access-date=13 December 2022 |date=23 October 2022}}</ref>

== Aftermath ==
Reddy and Thakur received legal notice from [[Central Drugs Standard Control Organisation]] (CDSCO) after commenting on the deaths of more than 66{{nbs}}children in [[Gambia]] caused by 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 of the nation.<ref>{{cite web |author1=Ashwine Kumar Singh |title=Cough syrup deaths: Why is India's drug regulator going after Dinesh Thakur and T Prashant Reddy? |url=https://www.newslaundry.com/2022/10/26/cough-syrup-deaths-why-is-indias-drug-regulator-going-after-dinesh-thakur-and-t-prashant-reddy |website=[[Newslaundry]] |access-date=13 December 2022 |date=26 October 2022}}</ref><ref>{{cite web |author1=G.S. Mudur |title=Suit threat against activist, lawyer for questioning CDSCO's role in Gambia deaths |url=https://www.telegraphindia.com/india/suit-threat-against-activist-lawyer-for-questioning-cdscos-role-in-gambia-deaths/cid/1892659 |publisher=[[The Telegraph (India)| The Telegraph]] |access-date=13 December 2022 |date=18 October 2022}}</ref>

== See also ==
*[[Drugs and Cosmetics Act, 1940]]
*[[Pharmaceutical fraud]]
*[[Pharmaceutical industry in India]]
*[[Lists of pharmaceutical industry topics]]

== References ==
{{reflist}}

== External links ==
*Book excerpt, [https://scroll.in/article/1034609/truth-pill-this-book-examines-how-some-indian-drugs-get-away-without-meeting-quality-standards 'Truth Pill': This book examines how some Indian drugs get away without meeting quality standards] ([[Scroll.in]])

{{Public health|state=collapsed}}

{{DEFAULTSORT:Truth Pill}}
[[Category:2022 non-fiction books]]
[[Category:Simon & Schuster books]]
[[Category:English-language non-fiction books]]

The Truth Pill - Revision history

Optimalvapors: new first details w/ infobox