Review: The Pill of Truth; The myth of drug regulation in India by Dinesh S Thakur and Prashant Reddy T

0

For most of us, a doctor’s orders are sacrosanct; follow the prescription, do not miss a dose and complete this antibiotic treatment. The ritual cannot and should not be changed. It is only when the side effects of a particular drug begin to appear that the individual feels compelled to deliberate over the intricacies of medical science and, more importantly, the composition of the bitter pill he is given. was asked to swallow.

In The Truth Pill: The Myth of Drug Regulation in Indiachemical engineer Dinesh S Thakur and lawyer Prashant Reddy T not only expose episodes of immorality among India’s drug regulatory bodies (manufacturing and trading), but lays bare flaws in the judicial structure and an establishment accomplice playing the game.

512pp, ₹899; Simon & Schuster India

They begin their investigation with the January 2020 incident when 11 children from the Udhampur district of Jammu and Kashmir died of a mysterious illness after consuming a cough syrup called COLDBEST, manufactured by Digital Vision, a company pharmaceutical company based in Himachal Pradesh.

According to the authors, when the Regional Drug Testing Laboratory, Chandigarh tested the samples from the COLDBEST batch, they alleged that the cough syrup had tested positive for high percentages of “diethylene glycol” (DEG), a strong industrial solvent used in the manufacture of antifreeze, brake fluid, etc. It is never used in the manufacture of medicines and can be fatal to humans who consume it as it causes kidney failure, which can eventually lead to death.

The book claims that DEG adulteration is a recurring problem and the main reason for this is that many Indian pharmaceutical companies fail to test raw materials or the final formulation before they are shipped to the market for sale. Almost two years have passed and there have been no legal implications of this breach and negligence, and Digital Vision has yet to be prosecuted for the children’s deaths.

Coincidentally, Dinesh and Prashant’s book comes out shortly after a similar, more recent incident in August 2022, when 66 children died in the West African nation of Gambia after consuming Indian-made cough syrups. 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 uncontrolled pharmaceutical practices are rampant. The Truth Pill digs reveal several other irregularities that make the consumer wonder if their handy medical kit containing common over-the-counter drugs and other prescribed pills can be trusted.

The first is the manufacture and trade of NSQ (Non Standard Grade) drugs. A drug is declared NSQ when it fails the quality tests prescribed by the legally recognized pharmacopoeia. In the Indian market, the trade in these drugs is widespread. Contaminations include glass particles and bacterial endotoxins, both of which can have dangerous consequences for patients, ranging from aseptic shock to death.

Acquittals and convictions of companies and individuals engaging in these illegal practices tend to be lengthy and ineffective. Administrative action is taken to suspend or revoke manufacturing licenses, but this is little substitute for a criminal penalty for endangering life.

Next is traditional Indian medicine, popularly known as Ayurveda, which is considered less toxic than modern medicine. While Ayurvedic medicine has its roots in herbal cures, American studies have found the presence of “heavy metals” in it. Patients of Indian origin in the United States have fallen ill due to heavy metal poisoning after consuming certain Ayurvedic supplements. Doctors in India have also repeatedly reported metal poisonings in patients with a history of consuming Ayurvedic remedies.

Authors Dinesh S Thakur (R) and Prashant Reddy T (Courtesy of Simon & Schuster)

The problem here too is that Ayurvedic cures, unlike modern medicine, can be administered without a prescription from a qualified doctor. The presence of heavy metals is not the only problem. There have been cases of surreptitiously mixing steroids into Ayurvedic powders that claim weight gain or weight loss, injecting Sildenfil, more commonly known as Viagra, into Ayurvedic pills intended to boost sexual vigor, and mixing of these drugs with strong painkillers.

Despite these revelations, the penalties are relatively light. A maximum fine of 20,000 and a maximum prison sentence of one year can be imposed on a person found guilty of selling adulterated Ayurvedic “remedies”.

A former director of project and information management at Ranbaxy, Dinesh Thakur’s expose of the pharma giant’s 2013 fraud was well documented in his book Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharmacy. He resigned and became a whistleblower with the US Food and Drug Administration, eventually bringing the multi-billion dollar giant to its knees.

His second book co-authored with intellectual property attorney Prashant Reddy T is equally illuminating. Hopefully, recent events and their examination by books like this will lead to the implementation of active drug regulatory policies as well as strong public law, ending unethical pharmaceutical practices in the world of Indian medicine.

Arunima Mazumdar is a freelance writer. She is @sermoninstone on Twitter and @sermonsinstone on Instagram.

Share.

Comments are closed.