Drug regulator tightens safety norms after cough syrup deaths

BHOPAL: After the death of 23 children in Madhya Pradesh, including 20 from Chhindwara, following the consumption of Coldrif, a cough syrup laced with the killer chemical diethylene glycol (DEG), Drugs Controller General of India (DCGI) Friday made it mandatory to test for both DEG and ethylene glycol (EG) in all raw materials and finished .

Earlier, such testing was required only for raw materials, leaving a crucial gap that allowed toxic solvents to enter finished syrups undetected. DCGI, which heads Central Drugs Standard Control Organisation (CDSCO), is responsible for approving, regulating, and monitoring the quality of medicines in India. Moved by the disaster, Madhya Pradesh Food and Drugs Administration (MPFDA) wrote to DCGI Thursday, urging it to include DEG and EG testing in the “general monograph of the Indian Pharmacopoeia” (IP) — the national rulebook that sets quality standards and test methods for medicines sold in India.


Within a few hours of receiving the MPFDA letter, DCGI notified the amendment and directed Commission (IPC) — the autonomous scientific body under Union ministry of health and family welfare responsible for setting and updating India’s official drug standards — to take immediate action. IPC Friday issued ‘Amendment List-09’ to IP 2022, officially introducing DEG and EG testing as a mandatory requirement for all oral liquid formulations.

It also issued a circular across India, informing all state drug controllers, CDSCO zonal offices, members of the scientific body of IPC, directors of drug testing laboratories, and major industry associations, including IDMA, OPPI, BDMA, FOPE, FSSAI, and SmallScale Industry Associations, to enforce the new testing standards without delay.

The order, signed by IPC secretary-cum-scientific director Dr V Kalaiselvan, directs that the amount of DEG and EG shall not exceed 0.10% and must be determined by gas chromatography. TOI is in possession of the MPFDA’s letter to DCGI and the IPC circular. “This closes a critical regulatory loophole exposed by repeated syrup-linked deaths,” an official said, calling it a decisive step toward restoring public trust in India’s drug safety system.
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