Cough syrup under scrutiny.
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Amid concerns over the safety of cough syrups for children, the Telangana Drugs Control Administration (DCA), has mandated strict compliance to eliminate the risk of toxic contamination in oral formulations. The DCA has made testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) compulsory at every stage of manufacture, following a virtual meeting held with all syrup manufacturers in the State on October 10.
The move comes in the backdrop of death of children in Chhindwara district of Madhya Pradesh allegedly caused by adulterated cough syrups containing DEG.
As part of the directions, the DCA has instructed that pharmaceutical aids and excipients such as glycerin, propylene glycol, and sorbitol solution must be procured directly from their manufacturers. “All raw materials are required to meet pharmacopoeial standards, and only pharmacopoeial-grade excipients are to be used in production. It has been made mandatory for manufacturers to test all raw materials for Diethylene Glycol (DEG) and Ethylene Glycol (EG) prior to use, with the permissible limit for both not exceeding 0.10% as per pharmacopoeial monographs,” the minutes of the meeting said.
To ensure thorough quality assurance, manufacturers have been directed to sample and test every individual container or pack of excipients upon receipt of raw materials. Similarly, all finished liquid oral products must be tested for DEG and EG in accordance with the amendment to the Indian Pharmacopoeia 2022, dated October 10. The DCA has insisted that manufacturers ensure authentic and verifiable testing for the absence of DEG and EG, particularly when testing is outsourced to approved laboratories.
DCA officials will also conduct surprise inspections of manufacturing facilities to verify compliance with these directives.
Published – October 15, 2025 10:39 am IST
