What is the link between cough syrups and child deaths in two States? 

Following the deaths of over 14 children in MP and Rajasthan, investigations by central and state regulatory authorities have put the spotlight on cough syrups given to children. Initially, the regulators said some of the product samples picked up from the site in MP did not contain the contaminant Diethylene Glycol (DEG). However, follow-up action by the Tamil Nadu drug regulatory authority found that samples of the syrup made by Sresan Pharma — the company that supplied the cough syrups to MP — did contain DEG, at more than “permissible” levels, according to a Health Ministry communique. Health-related authorities are still investigating this. Two deaths were reported in Nagpur (Maharashtra), as well.

In Rajasthan too, reports initially linked the deaths possibly to cough syrup from Jaipur-based Kaysons Pharma, and subsequently the State banned products containing dextromethorphan.

Both companies have not made any public statements following the incidents.

What is DEG?

Diethylene glycol (DEG) and ethylene glycol (EG) are toxic substances used as industrial solvents and antifreeze agents that can be fatal if taken, even in small amounts, especially for children, says the World Health Organization. The widely used analytical technique to test pharmaceutical products for DEG/ EG is Gas Chromatography, it added.  

 How does it get into a pharmaceutical product like cough syrups?

Drugmakers use excipients (inactive substances) in their products, and pharma-grade propylene glycol is one such used in drugs and cosmetics, say global food and drug regulatory authorities. Industry insiders explain that propylene glycol needs to be sourced from an authentic seller and tested for impurities like DEG. The final formulation is tested again (in-house or outsourced) for contaminants (DEG), before being released into the market. All these documents are supplied to the State regulatory authorities who check if the company has adhered to all requirements. The regulator also runs random checks on products picked up from the factory or marketplace.

In the MP case, reports suggest the DEG component was over 46 per cent (it should be less than 0.1 percent), industry-insiders say. And that, if true, is a grave miss by all those who ran quality checks on the product and cleared it for consumption.

The incident also raises questions on integrity of the supply chain, and the procurement process of these products at hospital and retail levels.

Wasn’t there an international controversy involving cough syrups from India?  

Yes. In 2022, child deaths in Gambia were linked to possibly contaminated cough syrups from India. Similar incidents were reported from countries like Uzbekistan. Subsequently, drug companies exporting cough syrups are now mandated to get it tested before it leaves the Indian shores.  

But DEG is a recurring villain on the cough syrup landscape — be it the Jammu or Gambia incident. About 39 years ago, a DEG-led incident in Mumbai — where 14 people died — led to the Lentin Commission report that came down hard on health and hospital administrators, corruption and regulatory lapses.

So are cough syrups unsafe for children?

Paediatricians advice not to give cough syrups to infants (below 2 years). The Indian Medical Association says, in most cases, the cough or cold resolves on its own. And if prescribed, the dosing is based on clinical evaluation by the doctor.

If you have to buy a cough syrup (or any medicine actually) — ensure it is on medical advice, and the medicine is made by a reputed company, bought from a registered chemist, with a receipt.