Deadly cough syrup scandals pose hard questions for India’s regulators

Repeated incidents have claimed the lives of dozens of children

- Debarshi Dasgupta India Correspondent

At least 22 children have been killed since September in the states of Madhya Pradesh and Rajasthan after consuming Coldrif.

(REUTERS)

Diethylene glycol (DEG) is an organic compound that is commonly used as an industrial solvent in antifreeze mixtures and brake fluids. But, in India, DEG is ending up with worrying frequency where it should never be - in cough syrups for children.

The repeated presence of this toxic substance in medicines has had devastating, fatal consequences in India and abroad, while also bringing the country’s lax drug regulatory setup under intense scrutiny.

In the latest instance of such contamination, at least 22 children have been killed since September in the Indian states of Madhya Pradesh and Rajasthan after consuming Coldrif, a cough syrup adulterated with industrial grade DEG.

Coldrif is produced by Tamil Nadu-based Sresan Pharmaceuticals, a relatively small manufacturer.

Cough syrups are made with propylene glycol (PG), a colourless and viscous liquid that is used as a solvent for syrupy medicines. It is available in two grades: pharmaceutical and commercial.

The pharmaceutical variant has a strictly controlled presence of DEG, if any, unlike the cheaper commercial kind, which has far higher levels of the compound, making it unfit for human consumption. Manufacturers, knowingly or unknowingly, use commercial-grade PG when making cough syrups to cut costs.

Even small amounts of DEG can prove fatal for children, with kidney failure a common occurrence. The syrup in question — Coldrif - contained 48.6 per cent DEG, far exceeding the maximum permissible limit of 0.1 per cent.

Over the years, DEG in Indian-made cough syrups has claimed the lives of dozens of children domestically and abroad. In 2022-23, Indian DEG-contaminated syrups were linked to the deaths of 70 children in The Gambia in West Africa and another 18 in Uzbekistan.