REGULATOR APATHY LED T0 CHILDREN DYING FROM CONTAMINATED SYRUP

Bia, Uzbekistan and Cameroon after consuming Indian-manufactured syrups contaminated with diethylene glycol or ethylene glycol.

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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 syrups—Promethazine Oral 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 atleast six child deaths in Yaoundé, Cameroon.

Each incident involved a different manufacturer. Each was detected only after foreign governments investigated fatalities, even as the Indian regulators failed to detect any of these violations beforehand.

The government's own words, tabled in Parliament, confirm that CDSCO's regulatory model is reactive by design. In a written reply to the Lok Sabha on 20 December 2024 (Unstarred Question No. 4285), the Minister of State for Chemicals and Fertilizers stated that drug alerts are issued when cases are reported and that action is taken by the concerned state licensing authorities under the Drugs and Cosmetics Act.

The same reply revealed that risk-based inspections of manufacturing units began only in December 2022, decades after the law came into force. Just over 500 premises had been inspected nationwide by late 2024, and about 400 enforcement actions were taken, all by state authorities rather than the central regulator.