A clue of the shocking reality of how medications are generated in India and how inadequately they are controlled may be seen in the highly humiliating news that cough syrups produced by Maiden Pharma are to blame for the deaths of 66 children in The Gambia. The Truth Pill: The Myth of Drug Regulation in India, a book that was just released last month, has the whole account of the events. Dinesh Thakur and Prashant Reddy T, the book’s writers, pose two important issues. First, are Indian medications consistently reliable and secure? Second, are generic medications produced in India just as effective as brand-name medications?
No, is the response. The authors respond positively to the first query, stating that “India is staring at a tsunami of non-standard grade pharmaceuticals circulating in the market… We believe there are hundreds of thousands or maybe millions of patients who are affected overall. They respond directly to the second query, saying, “We think not.”
Their 500-page study is comprehensive, well-researched, and covers a wide range of topics. From how medications are created, including the fact that some businesses manufacture without a licence, to the promises they make, the absence of equipment to do necessary testing, and the reality that some manufacturers commit several violations without being penalised,
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 use the prologue’s example from the writers to demonstrate the frightening circumstance. After reportedly consuming a cough medication supplied by Digital Vision that contained diethylene glycol (DEG), 21 kids died in Jammu in 2019. Antifreeze and braking fluid both employ the industrial solvent diethylene glycol. Since 1972, there have been five cases of DEG poisoning in India. Because “Indian pharmaceutical businesses frequently fail to examine either the raw components or the finished formulation before sending it to the market,” its existence goes unnoticed.
This wasn’t Digital Vision’s first purported error, however. “The company’s medications failed quality testing on a total of 19 occasions between 2012 and 2019,” the report said. According to the book, the state high court of Himachal Pradesh was informed by the drug controller there that the factory lacked the necessary equipment to test for DEG contamination. The drug controller evidently missed the 19 previous opportunities to catch this. The absence of such tools “should have been discovered during these inspections, resulting in an instant termination of the company’s production licence,” according to the authors.
What happens if a medicine does not contain what its label indicates it contains? The Olcare Laboratories-produced azithromycin mentioned in the book should have 200 mg of azithromycin, but only includes 25.69 mg, or 12.85% of that amount. The tablet simply (does) not contain enough of the active component to manage the infection, the authors write in their conclusion. “There is a high risk of the patient dying.”
“It is apparent that a lot of Indian pharmaceutical manufacturing facilities are entirely flouting quality and process control regulations,” I would argue is the book’s thesis. The problem is that they “rarely suffer any monetary consequence for a crime that might significantly harm or kill others.” This is really scary. However, none of us can do anything if the government does not take action.
