India's drug regulation is stuck in a time warp

Earlier this month, at least 20 children died in Madhya Pradesh and Rajasthan after consuming Coldrif cough syrup, which tested positive for diethylene glycol (DEG) —a highly toxic industrial chemical known to cause kidney failure.

- Ramanan Laxminarayan

This tragedy is not an isolated event. In 2022, dozens of children in The Gambia, Uzbekistan, and Cameroon died after ingesting India-made cough syrups (manufactured by Maiden Pharmaceuticals) that also contained DEG.

To be the world’s pharmacy is both an honour and a profound responsibility. India produces roughly one-fifth of the world’s medicines and an even larger share of its generics. The pharmaceutical industry contributes nearly 6% of export earnings and provides essential drugs for citizens. Yet, drugs fail for two main reasons: Some are counterfeit, containing no active ingredients, while others are contaminated due to poor manufacturing practices. In the case of Coldrif, it is likely that the manufacturer used industrial-grade glycerin or propylene glycol already tainted with DEG, rather than the more stringently controlled pharma-grade version. A 2023 survey found that around 3% of drugs sold in India were substandard — but such cross-sectional surveys rarely capture episodic manufacturing failures that lead to tragedies like this one. Moreover, it is seldom that anyone connects deaths occurring in different locations to a single causal agent — a defective drug. The true risk of substandard medicines is, thus, likely far greater than the data suggest.