BHOPAL: In the wake of the tragic death of 23 children in Madhya Pradesh, predominantly from Chhindwara, due to the consumption of Coldrif, a cough syrup containing the hazardous chemical diethylene glycol (DEG), the Drugs Controller General of India (DCGI) has taken significant regulatory action. As of Friday, it is now mandatory to test for both DEG and ethylene glycol (EG) in all raw materials and finished pharmaceutical products.
Previously, testing requirements applied only to raw materials, creating a gap that allowed toxic solvents to go undetected in finished syrups. The DCGI, which oversees the Central Drugs Standard Control Organisation (CDSCO), is tasked with approving, regulating, and monitoring the quality of medicines in India. Responding to the crisis, the Madhya Pradesh Food and Drugs Administration (MPFDA) sent a letter to the DCGI on Thursday, urging the inclusion of DEG and EG testing in the Indian Pharmacopoeia (IP) – the national standard document for quality control and testing methods for medicines sold in India.
Within hours of receiving the MPFDA’s request, the DCGI issued an amendment mandating the Indian Pharmacopoeia Commission (IPC) – the autonomous scientific body under the Ministry of Health and Family Welfare responsible for updating drug standards – to act swiftly. On Friday, the IPC issued ‘Amendment List-09’ to the IP 2022, officially mandating DEG and EG testing for all oral liquid formulations.
The IPC has also circulated this information nationwide to all state drug controllers, CDSCO zonal offices, members of the IPC’s scientific body, directors of drug testing laboratories, and major industry associations, including IDMA, OPPI, BDMA, FOPE, FSSAI, and Small Scale Industry Associations. The new regulations require that the levels of DEG and EG shall not exceed 0.10% and should be determined by gas chromatography.
“This action addresses a critical regulatory loophole exposed by previous syrup-related fatalities,” stated an official, emphasizing its importance in restoring public confidence in India’s drug safety system.
