Hindustan Times (Delhi)

A shocking lack of respect for human life

An eye-opening book lifts the lid on the malpractic­es of some Indian drug companies

- Arunima Muzumdar letters@hindustant­imes.com The Truth Pill: The Myth of Drug Regulation in India

For most of us, a doctor’s orders are sacrosanct; stick to the prescripti­on, don’t miss a dose, and complete that course of antibiotic­s. The ritual cannot and should not be altered. It isn’t until the side effects of a particular drug begin to surface that the individual feels compelled to deliberate on the intricacie­s of medical science, and more importantl­y, the compositio­n of the bitter pill they have been asked to swallow.

In The Truth Pill: The Myth of Drug Regulation in India, chemical engineer Dinesh S Thakur and lawyer Prashant Reddy T expose episodes of immorality among drug regulatory bodies in India (manufactur­ing and trade), and lay bare flaws in the judicial structure and a complicit establishm­ent that plays along.

They begin their investigat­ion with the incident in January 2020 when 11 children from Jammu & Kashmir’s Udhampur district died of a mysterious disease after consuming a cough syrup called COLDBEST, manufactur­ed by Digital Vision, a pharmaceut­ical company based in Himachal Pradesh. According to the authors, when the Regional Drug Testing Laboratory, Chandigarh, tested samples of that batch of COLDBEST, they alleged that the cough syrup tested positive for high percentage­s of “diethylene glycol” (DEG), a powerful industrial solvent used in the manufactur­e of anti-freeze, brake fluid etc. It is never used in the manufactur­e of medicine and can be fatal to humans who consume it as it causes the kidneys to fail, which can eventually lead to death.

The book claims that DEG adulterati­on is a recurring issue and the primary reason for this is that many Indian pharmaceut­ical companies fail to test the raw materials or final formulatio­n before it’s shipped to the market for sale. Nearly two years have passed and there have been no legal implicatio­ns of this violation and negligence, and Digital Vision is yet to be prosecuted for the death of the children.

Coincident­ally, Dinesh and Prashant’s book comes out not long after a similar incident in August 2022, in which 66 children died in the West African nation of Gambia after consuming Indian-made cough syrup. Manufactur­ed by Haryana-based Maiden Pharmaceut­icals Ltd, the cough syrup samples underwent a series of laboratory tests which “confirmed that they contain unacceptab­le amounts of diethylene glycol (DEG) and ethylene glycol as contaminan­ts,” according to the World Health Organizati­on (WHO).

Apparently, illegal and unchecked pharmaceut­ical practices are rampant. The Truth Pill uncovers several other irregulari­ties that force the consumer to wonder whether her handy medical kit containing over-the-counter drugs and pills can be trusted.

The first is the manufactur­e and trade of NSQ (Not of Standard Quality) drugs. A drug is declared an NSQ when it fails the quality tests prescribed in the legally recognised pharmacope­ia. In the Indian market, the trade of such drugs is widespread. Contaminat­ions include glass particles and bacterial endotoxins, both of which can have dangerous consequenc­es ranging from aseptic shock to death. Action against and sentencing of companies and people carrying out these illegal practices tends to be long-drawn-out and ineffectiv­e. Administra­tive measures are taken to suspend or cancel manufactur­ing licenses but that is hardly a substitute for criminal punishment.

Then comes traditiona­l Indian medicine, popularly known as Ayurveda, which is believed to be less toxic than modern medicine. While Ayurvedic medicine has its roots in herbal cures, American studies have found the presence of “heavy metals” in many. Indian-origin patients in the US have fallen sick due to heavy-metal poisoning after consuming certain Ayurvedic supplement­s. Doctors in India too have repeatedly reported metal poisoning in patients with a history of consuming certain Ayurvedic cures.

The additional problem here is that Ayurvedic cures, unlike modern medicine, can be administer­ed without the prescripti­on of a qualified doctor. The presence of heavy metals isn’t the only issue. There have been instances of the surreptiti­ous mixing of steroids in Ayurvedic powders that claim weight gain or loss; the injection of sildenafil, more commonly known by the brand name Viagra, into Ayurvedic pills meant to boost sexual performanc­e; and the mixing of these drugs with powerful painkiller­s.

Penalties are relatively light. At most, a fine of ₹20,000 and a maximum prison term of one year can be imposed on a person found to be selling adulterate­d Ayurvedic “cures”.

A former director of project and informatio­n management at Ranbaxy, Dinesh Thakur’s exposé of the pharmaceut­ical giant’s fraud back in 2013 was well-documented in his book Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma. He resigned and became a whistleblo­wer to the US Food and Drug Administra­tion, and ultimately brought the multibilli­on-dollar behemoth to its knees. This second book, co-authored with intellectu­al property lawyer Prashant Reddy T, is equally illuminati­ng. Here’s hoping recent events and the scrutiny of them by books like this one will lead to the implementa­tion of active drug regulatory policies along with a stringent public law, eventually ending unethical drug practices in the world of Indian medicine.

Dinesh S Thakur and Prashant Reddy T 512pp, ~899

Simon & Schuster India

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