REGULATOR APATHY LED TO CHILDREN DYING FROM CONTAMINATED SYRUP

The deaths of at least 20 children after consuming spurious cough syrup have once again exposed the extent to which India's national drug regulator has hollowed out from within.

- ABHINANDAN MISHRA

The Central Drugs Standard Control Organisation (CDSCO), charged with ensuring the safety, quality and efficacy of medicines across the country, responded to the tragedy with the familiar theatre of raids, sample seizures and licence suspensions.

But parliamentary replies, budget documents and a decade-long trail of corruption analysed by this newspaper, make it clear that the institution is neither equipped nor willing to do what it was created to do: prevent such incidents before they happen.

The contaminated cough syrup in the present case, Coldrif, contained diethyl-ene glycol nearly 500 times the permissible limit. It was manufactured in Tamil Nadu, distributed across state lines and consumed in Madhya Pradesh and Rajasthan without a single regulatory red flag being raised.

This was not an isolated failure.

Between October 2022 and March 2023, at least 90 children died in The Gambia, Uzbekistan and Cameroon after consuming Indian-manufactured syrups contaminated with diethylene glycol or ethylene glycol.

In October 2022, WHO issued a global medical product alert after identifying four syrups made by Maiden Pharmaceuticals in Haryana as the likely cause of acute kidney injury that killed at least 66 children in The Gambia. The syrPromethazine Oral ups Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup contained toxic levels of diethylene glycol and ethylene glycol.

Two months later, in December 2022, Uzbekistan's health ministry reported the deaths of 18 children after ingesting Doc-1 Max cough syrup manufactured by Marion Biotech in Noida.

Laboratory testing again found unacceptable levels of ethylene glycol. WHO issued another alert in January 2023.

In March 2023, WHO issued a third alert after contaminated Naturcold syrup made by Fraken International of India was linked to at least six child deaths in Yaoundé, Cameroon.