Guide Evaluation: ‘The Reality Capsule: The Fable of Drug Regulation in India’

By Aparajita Lath

The Truth Pill, authored by Dinesh Thakur and Prashant Reddy, is a monumental work that convincingly exhibits that drug regulation is however a delusion in India.

Of their investigative fashion, the authors clarify drug regulation in India by way of the lens of historical past, each Indian and world. The guide’s mixture of historical past and modern points makes for an immersive and compelling learn. It might, nonetheless, go away you feeling frightened, given the dysfunctional regulatory system in India and the affect this will have on sufferers around the globe. Nonetheless, the guide not solely highlights issues but in addition presents a number of well-thought-out and actionable paths to reform.

The guide was launched in October, in an ominous coincidence with information of the death of nearly 70 children in Gambia, West Africa as a result of consumption of cough syrup contaminated with diethylene glycol (DEG), which had been made in India. Because it occurs, the prologue narrates historic regulatory failures which have led to an “epidemic” of DEG poisoning in India, virtually predicting this horrible incident in Gambia. India has had not less than 5 main circumstances of DEG poisoning up to now. Most not too long ago, in 2020, 11 children in India died of DEG poisoning. The guide explains that regardless of these occasions, DEG adulteration continues as a result of regulatory failures.

This is just one instance of the deep rot inside the system. As defined throughout numerous chapters, a daunting variety of quality-related violations, abysmal prosecution charges, low to no punishments, and sluggish to no modifications are attribute options of the system. In truth, earlier than publishing the guide, the authors petitioned the federal government, highlighting evident regulatory points, however the authorities turned a blind eye.

The guide depends on major sources of knowledge — primarily authorities reviews, judicial choices, and authorities knowledge. The ultimate product is a results of grit, dedication, and several other years of information gathering. Accessing info associated to authorities companies and departments just isn’t simple and such opacity feeds into the failures of the regulatory system on the whole. As revealed within the guide, the authors needed to combat with the drug controller earlier than the Delhi Excessive Courtroom for over two years to compel the discharge of a damning authorities report on suspicious drug approvals. The authors have made their wealthy assortment of sources out there online.

The guide accommodates eleven chapters that present an entire image of the drug regulatory panorama in India. The primary two chapters present historic context to drug regulation globally and in India. Incidents that led to states stepping-in to control medicine are explored. Topical points resembling conventional drugs and Ayurveda are defined intimately in chapters seven and eight. These chapters throw mild on attention-grabbing features of Ayurveda and associated regulatory, security, and different issues. Chapters three to 6 discover vital regulatory gaps and failures round NSQ (not of normal high quality) medicine, gaps in security and efficacy necessities for brand spanking new medicine, regulatory failures associated to generic medicines, and points with prosecutions and punishments for regulatory violations. The authors additionally focus on provide chain features of the system, together with on-line pharmacies and points with branding and drug ads. The Reality Capsule concludes by providing a number of attainable paths to reform.

Regardless of being referred to as the “the creating world’s pharmacy,” Indian drug regulation has been under-covered and under-studied, and occupies little house in public debate. This guide modifications that and pushes the difficulty into the highlight.

The Reality Capsule has created vital pleasure in India and the authors have been interviewed by a number of main Indian journalists and media homes. Certainly, it’s a should learn for these all for drug regulation, as regulatory failures affect not simply India but in addition its buying and selling companions.