By
Dinesh Thakur and Prashant Reddy T.
On March 25, 2023 the Economic & Political Weekly (EPW) published a review of our book – The Truth Pill: The Myth of Drug Regulation in India by Dr. Anant Phadke, a co-founder of the All India Drug Action Network and a trustee of Low Cost Therapeutics (LOCOST), a pharmaceutical manufacturing enterprise based out of Baroda, Gujarat.
This book review is problematic for many reasons, the most obvious one being the fact that EPW has not made some key disclosures. For instance there is no disclosure in the review that Phadke and his fellow activists are a subject of critique in our book because of the very obvious conflict of interest they face in their dual roles at trustees of LOCOST and co-founders AIDAN. Would a public health activist advocate for stricter punishment for the manufacturers of sub-standard medicines if the activist was also sitting on the board of a pharmaceutical manufacturer? Most definitely not; and Phadke is the perfect example as we will demonstrate in this piece.
A second disclosure not made in the review, is that our book has pointed out how LOCOST and Srinivasan (co-founder of AIDAN) have been convicted by a Chief Judicial Magistrate, Pune for the crime of manufacturing sub-standard drugs used for treating hypertension. LOCOST’s drugs were found to have only 36.5% of the active ingredient mentioned on the labelling. Untreated hypertension can cause strokes and heart attacks. The punishment that followed the conviction was quite paltry. The court imposed a fine of merely Rs. 10,000 and simple imprisonment till the rising of the court. This, when the law requires a minimum of one year punishment unless there are “special” reasons, which the magistrate has to justify in writing. As we have pointed out in our book, LOCOST is not the only beneficiary of this lenient sentencing policy – this is a standard sentencing practice in at least Maharashtra, Karnataka and Tamil Nadu. To have a trustee, like Phadke, of an enterprise convicted of manufacturing substandard drugs, actually write a review of a book on drug regulation without disclosing the fact of the conviction is a serious breach of editorial ethics on part of EPW. But it gets even more problematic. In his review, Phadke mocks our criticism of such lenient sentencing practices. He states in his review:
“But the authors unjustifiably deprecate that many judges use the proviso in the current Drugs and Cosmetics Act (Section 27) of punishment for less than a year (“if the court feels for adequate and special reasons to be recorded”), including punishment of “imprisonment till the rising of the court.” They seem to imagine that they have a better understanding of justice than all the concerned judges.”
Our criticism, unlike Phadke’s understanding, was grounded in the standards laid down by the Supreme Court in a series of precedents where the court discussed the meaning of “special reasons” and criticised the general leniency shown by magistrates towards white collar crime. (p. 102-103) In all the judgments we came across in our research, including the LOCOST case, the criteria laid down by the Supreme Court was never met.
Even more astonishing are Phadke’s views on criminal penalties for the manufacturers of sub-standard drugs. He claims that our demand for prosecution of every case is unjustified because manufacturing defects are known in every industry and that any prosecution should be preceded by an investigation to establish whether there was criminal intent, mala-fide intention, negligence, genuine mistake or incompetence. Manufacturing defects in the case of drugs have serious consequences for the health of patients and cannot be compared to other products. More pertinently Section 27(d) of the Drugs & Cosmetics Act, 1940 requires absolutely no assessment of criminal intent or lack of it. As long as the drug fails quality testing, the manufacturer is to be prosecuted and convicted. That is the law.
Should it be reformed? Yes, there is room for rethinking the nature of criminal punishments, as we accept in our book but until the law is what it is, it should be followed. More worrying is the fact that the pharma industry has been lobbying for complete decriminalisation through the Jan Vishwas Bill – a move that both of us oppose and have written about publicly in the Economic Times. AIDAN on the other hand has maintained silence on the issue perhaps because their co-founders who are on LOCOST’s Board will no longer face the threat of jail time under the new provisons. Without adequate disclosures by EPW, a reader will not fully appreciate this nuance while reading the book review. This is why editorial disclosures are absolutely necessary.
Misrepresenting the arguments in our book
Lack of disclosures apart, there is also the issue of illogical and misrepresentative arguments made by Phadke in his review. For example, he begins with the grand claim that there is a great conceptual confusion in our book when we discuss the issue of generic drugs. He claims that there are two definition of generic drugs – one that deals with drugs that are off-patent and the other is the category dealing with drugs that lack a brand name. He then proceeds to accept that the second category does not exist in India, stating “If the authors imply the second meaning, there are almost no generic medicines in the Indian retail market”. If the second category does not exist in India, why would anybody discuss it? It would be illogical to do so. Leaving that aside, Chapter 6 of the book is crystal clear that we are dealing with off-patent generic drugs.
The other issue that Phadke repeatedly misrepresents in his review is that we are not clear on whether we are criticising Indian or foreign generic medicine. At one point he states: “The authors do not seem to realise that their allegation of Indian generic medicines being “substandard,” also applies to the off-patent medicines made and marketed by the Western MNCs in India.” At another point, he references Indian exports to the US and UK and states “The authors overlook the fact that these manufacturers exporting generics to regulated markets are very much part of the Indian generic industry.” This is a longstanding problem with Phadke and also AIDAN – both seem to view Indian generic companies as saints and foreign MNCs as sinners. On the other hand, our book has never taken this approach of going after either MNCs or Indian companies. It is a fool’s errand, in our opinion, to try and label different companies based on the nationality of their shareholders. This is exactly why our book is not about individual companies – it is about regulatory law and institutions in India. We harp on how India did not have basic regulations for bioequivalence and stability tests for generics drugs because of which much of the medicine made in India could not be trusted. Much of our criticism in the book will not apply to generics being exports to developed countries because those exports are governed by foreign regulations in developed countries, which are generally more rigorous compared to India.
The most startling misrepresentation in the book review is Phadke’s discussion on bioequivalence testing, since it is this issue that forms the basis of his most serious accusation against us: “Overall, these pages in the book unwittingly serve the interests of the big pharma/MNCs.”
To provide some context, one of the issues we raise with regard to regulations for approval of generic medicine in India, is the fact that bioequivalence studies were not mandatory until recently (2017). Bioequivalence studies evaluate the rate at which drugs are absorbed by the bloodstream of a human. If it dissolves at the same rate or about the same rate as the already approved reference product, it is deemed to be bioequivalent. Not all drugs require bioequivalence testing in humans and some drugs that qualify for “biowaiver” can be tested in laboratories for surrogate parameters. We dedicate about three and a half pages explaining the concepts of biowaivers, starting with the first scientific papers that discussed this concept. We also clearly state that “granting biowaivers could certainly open the door to a more affordable regulatory pathway” but we justify this optimism with detailed caveats on the steps required to make sure biowaivers are effective.
But if you were to read Phadke’s review without reading our book, you would come away with the impression that we have not even mentioned the word “biowaiver” in our book. In pertinent part, he points to an excerpt we reproduce of an expert committee to make bioequivalence testing compulsory before triumphantly declaring our argument as the “half-truth” because the committee also recommended biowaivers. Nowhere does he mention that we spend three and half pages discussing biowaivers, their acceptability and the issues regarding the government’s failure to clearly identify markers for biowaivers. He repeats this brazen lie towards the end of the review when he states:
“Moreover, the authors’ unscientific, exaggerated, across-the-board insistence on costly, bio equivalence studies (which also implies the use of India’s poor people as guinea pigs in huge numbers) as a precondition for permitting the manufacture of generic medicines”.
Phadke’s entire basis for the above accusation against our work is this out of context sentence that he reproduces in his review “bioequivalence testing for all generic drugs”. His review claims this sentence is on page 215 but we check page 215 and this phrase is not on that page. We presume he meant page 234 where this phrase does appear. But if Phadke was relying on page 234, his allegation is a brazen misrepresentation because that sentence on p. 234 is in context of a paragraph where we discuss how India initially made bioequivalence testing only for those generics in the “new drug” phase approved by the DCGI, while generics approved by states post the “new drug” phase did not require bioequivalence testing. For example, generic Glivec approved by the DCGI in 2004 would require bioequivalence testing but if a different manufacturer sought approval for their generic version of Glivec in 2010 from a state drug controller, they would not be required to submit bioequivalence testing data for approval. How does this make any sense? It is in this context that we make the argument that all generics require bioequivalence testing. Anybody reading that chapter, would come away with that understanding and also understand how we support biowaivers with certain caveats.
The final problem with Phadke’s review and this is unfortunately a common problem with reviews in India, is a complaint that we did not cover topics that he thought were important, namely the political economy of India’s pharma industry and the drug pricing issues in India along with our apparent failure to “appreciate” Indian pharma’s contribution to increasing access to medicine. This is a rather silly line of criticism because there already are books written on these issues. A history of the Indian pharma industry, partly exploring the political economy, was written by Sudip Chaudhari and published by OUP in 2008. On drug pricing, Ajay Bhaskarbatla has written an extensive book that was published by Springer in 2018. So why exactly should we be addressing these issues in a book on drug regulation and quality? The rather unfortunate answer is that several people in this country, especially access to medicine activists believe that is fine to manufacture substandard medicine as long as it improves access to medicine. As we ask rather pointedly in our book, of what use is medicine that does not work to cure disease?
Phadke’s book review and EPW’s decision to publish it without disclosures reflects poorly on both parties. EPW offered to publish a response but we have no intention of doing so because we simply do not trust EPW’s editors to be fair after their failures to make required disclosure about Phadke’s involvement in drug regulation in India. They have so far not accepted responsibility or apologised for publishing Phadke’s review without making the adequate disclosures.