Hindustan Times ST (Mumbai) - Live
India’s pharma sector has much to answer
The nationally embarrassing reports that cough syrups made by Maiden Pharmaceuticals are responsible for the death of 66 children in The Gambia are just a hint of the deplorable truth of how drugs are manufactured in India and how poorly regulated they are. The full story is told in a book published this month called The Truth Pill: The Myth of Drug Regulation in India. Its authors, Dinesh Thakur and Prashant Reddy T, raise two critical questions. First, are Indian drugs always safe and effective? Second, are Indian-made generic drugs as good as the original?
The answer is No. To the first question, the authors write: “India is staring at a tsunami of non-standard quality drugs circulating in the market … we suspect that the total number of patients affected … runs into hundreds of thousands perhaps millions.” To the second question, they are simply blunt: “We think not.”
Theirs is a detailed and well-researched 500-page study that covers a vast spread of issues. From the way drugs are made — including the fact some companies actually manufacture without possessing a licence — through to the false claims they make, the lack of effective machinery to carry out required tests and the fact that some manufacturers are guilty of multiple malpractices without action being taken. The book also extensively details India’s dismal regulatory regime. Our regulators “rarely, if ever”, physically inspect manufacturing plants but instead “ask for a copy of the manufacturing records of the batch” they are questioning, the authors write. The guidelines they follow discourage prosecution. Worse, when matters are taken to court, the sentence is frequently “simple imprisonment till the rising of the court”. That’s no punishment at all.
Let me illustrate the horrifying situation with the example the authors offer in their prologue. In 2019, 21 children died in Jammu after allegedly taking a cough syrup containing diethylene glycol (DEG) made by Digital Vision. Diethylene glycol is an industrial solvent used for antifreeze and brake fluid. This was the fifth incidence of DEG poisoning in India since 1972. Its presence remains undetected because “Indian pharmaceutical companies quite often fail to test either the raw materials or the final formulation before shipping it to the market.”
This was not the first alleged lapse by Digital Vision. Between 2012 and 2019, “the company’s drugs failed quality testing on 19 occasions in total”. The book reveals that the Himachal Pradesh drug controller, under whose jurisdiction Digital Vision falls, told the state high court the manufacturer lacked a proper facility to test for DEG contamination. The drug controller had 19 earlier opportunities to detect this but obviously failed to do so. The authors write that the lack of such equipment “should have been spotted during these inspections, leading to an immediate cancellation of the company’s manufacturing licence.”
Now, what are the consequences when a drug does not contain what its label claims? The book cites azithromycin, made by Olcare Laboratories, which should have 200mg of azithromycin but only contains 25.69mg which is 12.85%. The authors conclude: “There is a high possibility of the patient dying because the tablet simply (does) not have enough of the active ingredient to control the infection.”
The book also explains what happens when generic drugs, which are cheap and
A NEW BOOK ON THE SECTOR CONCLUDES THAT MANY FACILITIES ARE FLOUTING QUALITY AND PROCESS CONTROL PROCEDURES. YET THEY SELDOM FACE ANY MATERIAL PUNISHMENT. THIS MUST CHANGE
popular in India, are not the equivalent of the original. To be certain, they need to be put through bioequivalence testing. That rarely happens. The authors conclude: “The lack of mandatory bioequivalence testing has resulted in the approvals of hundreds if not thousands of brands of generics in India and it is very likely that many of these brands have adversely affected the lives of patients.”
I would say this is the book’s conclusion: “It is obvious that a number of Indian pharmaceutical manufacturing facilities are completely flouting quality and process control procedures.” Yet they “seldom face any material punishment for a crime that could seriously hurt or kill people.” This is truly frightening. But if the government doesn’t act, there’s nothing any of us can do.