Tharoor Line | Indian drug firms need heavy dose of quality check

The tragic news that 66 children in the West African country called The Gambia have died after consuming an Indian-made cough syrup, has been a rude wake-up call for all of us. For years we have been celebrating the successes of India’s pharmaceutical industry, which has established a reputation worldwide for making world-class drugs and generics far more cheaply than Western companies. We are world leaders in generic medicines for HIV/AIDS and tuberculosis. Our vaccine manufacturing during the Covid pandemic was another success story that made India’s name in the developing world. And yet this episode demonstrates that not is all well with the manufacturing, regulation and export of pharmaceuticals by India.

The cough syrup, from a company called Maiden Pharmaceuticals, was apparently laced with poisonous quantities of Diethylene Glycol, an industrial solvent used mainly for brake-fluid in vehicles. Tragically the same substance was already responsible for the death of 21 children in India three years ago, on that occasion thanks to a Himachal company called Digital Vision. But no lessons appear to have been learned.

As two authors, Dinesh Thakur and Prashant Reddy, explain in their new book, ‘The Truth Pill: The Myth of Drug Regulation in India’, Digital Vision gets away with making and selling sub-standard drugs because the drug regulators of Himachal Pradesh are not doing their job properly. The company lacks the equipment to even test for the presence of Diethylene Glycol in their drugs. That alone, say Thakur and Reddy, should have led to the cancellation of their manufacturing licence, but the laxity of the regulators meant they continued poisoning patients for years. Contaminated cough syrup has been responsible for five incidents of mass poisoning in recent years, causing the deaths of 33 children in Gurgaon in 1998 and 12 children in Jammu in 2020. Now with the Gambian tragedy, Maiden Pharmaceuticals has joined this Hall of Infamy.

It is, of course, bad enough that such sub-standard products are allowed to be made in India, and perhaps worse that they are allowed to be exported, causing tragedy abroad that also sullies India’s reputation and has rightly earned our country strictures from the World Health Organisation (WHO). But the deaths of those poor children in Gambia also serve as a warning to us in India, because all of us are buying and consuming drugs made by the same disreputable companies that are permitted by our sloppy regulators to endanger all our lives.

For instance, many of us have had to take the popular antibiotic azithromycin, which is often prescribed by doctors for respiratory and other infections. But according to Thakur and Reddy, if we were to buy azithromycin made by Olcare Laboratories, we are doing ourselves actual harm. A tablet which is sold by Olcare as containing 200mg of Azithromycin, they say, in fact only contains 25.69mg. In other words, we think we are treating our infection, but in fact are getting only 12.85% of the prescribed dosage and could risk even dying because the tablet does not have enough of the active ingredient needed to cure our infection. Not only will it not remedy our illness, but if by some miracle we survive, our body will have developed a level of tolerance to small amounts of azithromycin that will render the real thing less effective when we use it in future. I used to celebrate the fact that antibiotics in India cost a fraction of their price abroad, but a cheap price is hardly worth celebrating if the medicine doesn’t actually work as it is supposed to!

There is more bad news everywhere. A report by the Comptroller and Auditor General says that a quarter of the drugs purchased by the Indian armed forces are sub-standard. Our soldiers may be more at risk from Indian medicines than from the Pakistani or Chinese armies! Thakur and Reddy dismiss as unverified the claim in the 2016 national drug survey conducted by the National Institute of Biologicals, which says that only 3% of the drugs manufactured in India are sub-standard. They point out that the same survey established that 10% of all drugs supplied to the government are in fact sub-standard and unsafe. If our government and armed forces are having such pharmaceuticals inflicted upon them, what are the chances that we ordinary drug consumers are faring any better?

It is indispensable that we have tighter oversight of pharmaceutical companies, their manufacturing practices and export policies. Testing for quality control is indispensable across the board and yet our government does not require enough of it. Why would foreign countries continue to trust the “Made in India” label unless we seriously improve our performance? Our government should insist on testing and inspection of all drugs on the market and make reports of both publicly available. There is also a case for a national regulator, since the uneven quality of state regulators leaves us all vulnerable – a person in Kerala can as easily be poisoned by a drug manufactured in Himachal Pradesh as a patient in that state. It is shocking to learn that Indian regulators rarely personally conduct physical inspections of manufacturing plants, relying solely on reports from the manufacturer, and that even when they find irregularities, rarely resort to prosecution. This kind of shoddy regulatory regime is dangerous, because it provides the false assurance of oversight while in fact allowing drug companies to literally get away with murder. The central government must act in all our interests before it is too late – as it sadly is for the poor children of the Gambia.

What a match!

This last Sunday, when India was scheduled to play its first match of the ongoing T-20 cricket World Cup, I found myself in Goa, fulfilling a long-standing commitment to address a conference of Catholic universities. After my speech, I was booked to fly back to Delhi, but discovered to my horror that taking the scheduled flight would have meant missing the India versus Pakistan match entirely. I decided instead to stay on in my hotel room to watch the much-heralded event on television, even though the next flight home was only at 9.55pm. It turned out to be one of the wisest decisions I could have made. I was thrilled to see one of the great matches of this tournament and perhaps of all time, as the genius of Virat Kohli pulled an improbable last-ball victory for India from the jaws of defeat. I had feared ending the day feeling guilty about being so self-indulgent – but sometimes, not doing the responsible thing can actually prove to be the right thing!