An Important book written in ALL CAPS
Thakur, D. S., & Thikkavarapu, P. R. (2022). The Truth Pill: The Myth of Drug Regulation in India. Simon and Schuster.
Topics covered in this book:
- How approval for new drugs, new fixed drug combinations and new generics are supposed to work and how they actually work
- What are the quality standards and monitoring mechanisms in place for scientific medicine, as well as AYUSH.
- Laws governing AYUSH, scientific medicine and the production of drugs in India.
What I liked about the book:
- Thorough research into how things are supposed to work in the area of drug regulations in India and an even more detailed research and experience into the million ways in which it is failing to work. Seriously, these two know their drug regulation problems.
- Thorough understanding of the main players, organizations, lobbies etc. involved in this messy situation
- Stupendous amounts of cred as far as I am concerned due to being a whistleblower as well as a RTI crusader/activist and all the litigation they have tried.
- Focus on transparency, access to information, rights to quality
- Documentation of various types of issues and the corruption in different bodies
- Clear-sighted tracking of the bureaucratic games and political shenanigans around drug laws in the country.
What I learned from the book
- We have a lot of outdated laws regulating drugs and other allied health products. These are exploited and used by both the governance people and the drug companies to push a lot of outright shitty medicines to the public
- There is a LOT of corruption, incompetence and lack of transparency in the organizations that are supposed to be watchdogs and regulators
- Successive governments and bureaucracies have generally found ways to pass the buck, do ass-saving paper pushing and pandering to sentiments rather than make any substantial and scientific changes.
- We have a lot of under-equipped and underfunded drug regulators and inspectors
- The quality of drugs produced in India is for all practical purposes at the mercy of the individual pharma company that does the production and there’s very little if any, real oversight or really punishment for even serious lapses.
- Every month somewhere in this country, at least one pharma company is shown to have produced sub standard drugs and even then the judiciary seems to think harsh punishments are not needed. I mean, people have died and the dudes who made those meds never saw jail time.
Problems with the book
The whole book is narrated by someone who is shouting at YOU AND ALL THE IDIOTS WHO RUN THIS COUNTRY AND ALL THE CORRUPT DRUG MANUFACTURERS, THE INCOMPETENT JUDICIARY, THE CLUELESS LAW MAKERS OF NEWLY-INDEPENDENT INDIA WHO DID NOT HAVE 21ST CENTURY VALUE SYSTEMS OR KNOWLEDGE AND DRUG RIGHTS ACTIVISTS WHO ARE ALL CORRUPT TOO.
My blood pressure was measurably higher when I was reading this book. Seriously. There’s like four people the authors have anything nice to say about from 1923 -2023 (and two of them are dead). Oh, and the USFDA. They LOVE the FDA and the way things are done in the United States.
<sarcasm> I mean, I don’t blame them, they’ve been fighting the good fight all their lives when literally everyone else in India is asleep, incompetent and corrupt. </sarcasm>
I get it, though, one of the authors has been constantly targeted and harassed by various government agencies and big pharma. So I get where the tone is coming from, I know righteous indignation, I used to have a lot of it. Now I just have reflux and indigestion.
But the roid-rage-hulk-smash tone of the book made me want to put it down and stop reading about fifteen times. I stayed the course only because they did thorough research, and what is an activist without some righteous rage, really.
The other issues are that the policy and legal recommendations made in the book without fail made me wince, flinch and facepalm. The authors forget just how poor this country is, and just how many people there are. The authors also don’t know a damn thing about the practice of medicine in the real India. They are operating from an america-centric and america-learned model of how health should be dealt with.
The most important implied recommendation of this book seems to be BURN IT ALL DOWN.
Throughout the book they mention the dozens of parliamentary and other committees that have looked into these problems, and how so few of these reports see the light of day and fewer still get anything changed. Because the suggestions are not useful, or due to the unwillingness of the governance system to make any real changes.
This book has the same problem.
- They repeatedly suggest stronger laws, after describing just how poorly existing laws are implemented.
- They suggest that online pharmacies will solve the supply chain problem (omg i cannot even)
- They suggest that small pharmacists who are found to have bad drugs should be punished heavily.
- They repeatedly recommend increasing the legal pressure on smaller players in the supply chain.
You cant improve state capacity by making tougher laws.
You can’t fix corruption in high places by punishing the small guy.
Some medication is most definitely in many many cases better than no medication, talk to a doctor, any doctor.
You cannot copy-paste quality standards designed in USA and Europe to solve for India.
That’s not how anything works.
Would I prefer my patients got 40mg of Telmisartan every time they buy a drug, YES.
Do we need to improve the capacity of drug inspectors and dis-entangle the regulatory nightmare, HELL YES.
But do we do it by shutting down everyone who only has 20 mg of telmisartan in their 40mg tablets, heavens no. The 20 mg the patient gets at 0.05 Paise a tablet is worlds better than the 0 mg he will get at 2 rupees a tablet.
In the words of the y00ths I interact with, the authors desperately need to touch grass.