Photo: James Yarema/Unsplash
In an interview that reveals the horrifying picture of how unsafe and ineffective Indian drugs can be and often how poor the quality is of Indian-made generic drugs, authors Dinesh Thakur and Prashant Reddy T. say Prime Minister Narendra Modi’s advice to doctors to prescribe generic rather than branded drugs is unwise and can be dangerous.
The interview reveals that often, Indian patients buy drugs in the hope and belief they will cure them – only to discover that the drug does not live up to the claims on its label and, in the case of generic drugs, is often of sub-standard quality.
Thaur and Reddy recently published a book on this subject called The Truth Pill: The Myth of Drug Regulation in India.
Asked if Indian drugs are always safe and always effective, Thakur and Reddy said: “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.”
Asked if Indian-made generic drugs are as good as the original their answer was short and sharp: “We think not.”
Explaining in further detail the manufacturing process of generic drugs, the authors said that bioequivalence testing is necessary to make sure that the generic is as good as the original drug. About this, they say: “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.”
In 2017, the Indian government made bioequivalence testing mandatory but strangely not for drugs that were licensed before 2017. Since a large number of generic drugs were licensed before that date, they are still being made and sold without bioequivalence testing, Therefore, they can often be of non-standard quality, i.e. ineffective.
This is why Modi’s advice to doctors to prescribe generic drugs is unwise and dangerous. We simply cannot be confident of their quality, they said.
In the interview, Thakur and Reddy discussed one specific case study as an example to illustrate the problem with drug manufacturing and drug regulation in India. In 2019, 21 children died because of a cough syrup containing diethylene glycol (DEG), an industrial solvent used for anti-freeze and brake fluid. The amazing thing is that this was the fifth incidence of DEG poisoning since 1972. In other words, it keeps happening.
The deaths of 66 children in the Gambia, caused by cough syrups manufactured by the Haryana-based Maiden Pharmaceuticals, was also because of DEG poisoning.
The 2019 cough syrup was made by Digital Vision. Between 2012 and 2019, this company’s drugs failed quality testing on 19 occasions in total. All of that was before the incident of 2019. Shouldn’t it have been shut down rather than be allowed to continue to make drugs?
The Himachal Pradesh Drug Controller, under whom Digital Vision falls, told the high court that Digital Vision lacked a proper facility for testing DEG contamination. So the company was making cough syrups it was ill-equipped to make. More importantly, the Drug Controller had received at least 19 notices over a 10-year period that Digital Vision’s drugs have failed quality testing. In other words, the Drug Controller had 19 opportunities to conduct inspections and discover the company lacked equipment for testing DEG contamination. Either those inspections did not happen or they happened so ineptly that the lack of equipment was never discovered.
Also Read: India’s Drug Testing Has a Big Blind Spot: Officials Rarely Check for Impurities
After the 2019 incident, Digital Vision has been stopped from making cough syrups but it continues to make other drugs. We have no guarantee that those drugs are being made more safely than the cough syrups.
Speaking about whether Indian drugs justify the claims made by the manufacturer, Thakur and Reddy cited Azithromycin tablets made by Olcare Laboratories. Instead of 200mg of Azithromycin, they only contained 25.69 which is 12.85%. The two authors conclude: “There is a high possibility of the patient dying because the tablet simply did not have enough of the active ingredient to control the infection.”
The two authors say they have raised these issues with the health ministry but “the ministry has not even acknowledged our petitions; much less provide substantive replies”.
The interview discusses in some detail how regulators go about their work. How prosecutions frequently don’t happen even after there is clear proof of faulty manufacture. The interview also discusses how often judges pass lenient punishments i.e., “simple imprisonment till the rising of the court” which is no more than two or three hours and a paltry fine of Rs 20,000 or Rs 30,000.
Let me leave you with what are possibly the two author’s conclusions. First: “Pharmaceutical companies found often guilty of manufacturing non-standard quality drugs seldom face any material punishment for a crime that could seriously hurt or kill people.” So much for good governance.
Second: “It is obvious that a number of Indian pharmaceutical manufacturing facilities are completely flouting quality and process control procedures.” And they are getting away with it. Although the Maiden Pharmaceuticals story is not discussed in this interview, it’s now clear that what happened there is, it seems, happening frequently and has been happening for a long time.