The Truth Pill, by Dinesh Singh Thakur and Prashant Reddy Thikkavarapu investigates the challenges of drug regulation in India. It looks at why enforcement by authorities is lax; and how this sows the seeds for incidents such as the deaths of 66 children in The Gambia, likely the victims of spurious — and poisonous cough syrup — made by the Haryana-based Maiden Pharmaceuticals. Edited excerpts:
Question: What do you think the The Gambia incident does to the reputation of the Indian pharmaceutical industry?
Dinesh: Nothing. This is a flash in the pan. We have had five previous instances of mass poisoning since 1972 — in Gurgaon, Mumbai, Chennai — and in 2020 had a mass casualty event involving children in Jammu, and nothing has changed. There may be consequences for the Indian pharma industry in Africa but I’m not sure anything will change in India. Like in the past, the Indian industry, aided by the Ministry of Commerce, will launch a campaign (in Africa) to fortify their reputation and this will blow over. The point is not Africa. We have problems here.
Prashant: There have been complaints about Indian drug quality from Sri Lanka, Ghana, Vietnam but this is the first time we are seeing deaths. In India we appear to have been desensitised because when 11 children died in Jammu, in 2020, there was barely in coverage in the media. This is however an international incident and I don’t think Africa or the WHO will take it lying down.
Q: Why is it that instances of drug adulteration are rarely punished?
Prashant: There is a problem at the level of courts itself. In Tamil Nadu, we found 30 judgments from one judicial magistrate in Chennai. In all the cases, the company pleaded guilty or were found guilty. The judge fined them ₹1 lakh and sentenced them to ‘simple imprisonment till the rising of the court,’ which is basically till the judge rises from his seat. This is prevalent in several States. We’ve gone through orders where judges treat drug quality violations like traffic offences.
Q: Do you think that India’s problems with drug quality and lax enforcement are because we are a developing country and as incomes rise, the cost of compliance will rise too?
Dinesh: Drug regulation is a function of State capacity. There’s a world of difference between how Tamil Nadu does drug quality checks compared to Bihar. Most labs across States only test for whether the drug contains enough of the active ingredient and not for whether it dissolves properly or if there are things in the medicine that ought not to be there. This is the situation even in Himachal Pradesh, the hub of pharmaceutical drug manufacturing in India.
Q: Has the quality of drug testing and regulation improved over the last 30-40 years?
Prashant: In better governed States, yes. Gujarat does very good testing but very few prosecutions. However, drug regulation is not high priority for most States and therefore lack money and capacity. This is where the Centre should play a greater role. But the Centre is more interested in economic growth and the pharma industry is one of the few manufacturing success stories in India; due to this, they are willing to concede too much to the demands of the pharma industry. When people like Dinesh raise their voice, they are termed as ‘anti-nationals’ or ‘foreign agents’ (Dinesh is an overseas citizen of India and based in the United States). However, I’m optimistic that with an improvement in capacity, this race to the bottom might end.
Q: Why does India export lower quality drugs to Africa, when you’d normally expect ‘exported’ goods to be better than those sold domestically?
Prashant: Dinesh has witnessed this in Ranbaxy. India exports lower quality drugs to Africa because they know regulatory standards there are lower.
Dinesh: The Gambia is a small country and not equipped to scrutinize the quality of drugs. South Africa, Tanzania, Nigeria do have better quality checks as they have state capacity. Several smaller countries in western Africa don’t have the expertise to verify drug quality. This incident shows that the system, where they trust a quality assurance certificate from the Indian drug regulator, is broken.
Q: Dinesh, you are a chemical engineer and a whistleblower and Prashant, you are an intellectual-property expert and lawyer. How did you come together for this book?
Prashant: After the Ranbaxy settlement, Dinesh was looking for a lawyer in India to do some research on the drug regulatory system in India. I was working in a law firm and had done some work on this. So that’s how we began to work together. We spent a year understanding the system and there was no literature, nobody had written on it. We filed a 100 RTI applications, collecting information, and Dinesh wanted to file a PIL, so we filed two PILs.
Dinesh: I credit the Supreme Court that gave me the impetus to write this book. The then Chief Justice, T.S. Thakur dismissed the PIL I had filed (which challenged certain provisions of India’s Drugs and Cosmetics Act) as being of ‘academic interest’. Prashant was one of the lawyers arguing the case. The point of this book is to argue that this is not an academic issue.
Q: In the book, you suggest that the letter of the law governing drug regulation is far stricter than the guidelines the government recommends to drug manufacturers. Is this unique to India?
Dinesh: Guidelines don’t have the force of law. They are put out to instruct the bureaucracy (drug inspectors) on how to interpret the law. We point out how despite there being a recognition of the problems in drug regulation, the guidelines undermine the intent of the law. What is now happening is that the industry dictates how statutory bodies (that test drug quality, check and police drug violations) actually function. This is a form of regulatory capture.
Q: How much influence do pharmaceutical companies in the U.S. have in framing guidelines?
Prashant: Regulatory capture is a threat in most countries. However there’s ‘capture’ at the level of policy making and ‘capture’ at the level of enforcement. There are several valid criticisms of the U.S. Food and Drugs Administration, but when they come across instances where the law is violated, they do try and take some action like in the Ranbaxy case. In India, the guidelines are drafted in such a way that even egregious violations are winked at and not prosecuted. That’s worrying. India’s guidelines recommend rigorous prosecution only for counterfeit drugs but ‘substandard’ or minor drug violations are recommended to be punished only by suspending or cancelling their manufacturing licence. In India substandard drugs are a far bigger problem that adulterated or counterfeit drugs.
Q: When questions of drug quality come up, Indian pharmaceutical companies complain that Western drug standards are unrealistically high...
Prashant: We are not even saying ‘Western standards’ but follow Indian standards as prescribed by the Indian Pharmacopoeia Commission (a body that prescribes quality standards for drugs). When there’s a standard enforcing body, you cannot have bureaucrats undercutting those standards.