A month after child deaths related to contaminated cough syrups were reported in Madhya Pradesh and Rajasthan, the Telangana Drugs Control Administration (DCA) issued a new directive stating that every batch of basic solvents like glycerin, propylene glycol, sorbitol solution used in the manufacture of liquid oral medicines must be purchased exclusively from suppliers registered with the National Digital Monitoring System. The instructions form part of a detailed follow-up circular issued to all oral liquid manufacturers.
The circular builds on an earlier notice issued on October 13 that made testing of diethylene glycol and ethylene glycol mandatory at every stage of production.
A key direction in the latest guidance concerns a mandatory digital footprint for the high-risk solvents mentioned above. The DCA said manufacturers of these solvents must be registered under the digital monitoring system on the Online National Drugs Licensing System (ONDLS) portal of the Central Drug Standards Control Organization (CDSCO). Oral liquid manufacturers can use batches of such solvents only if they come from entities listed in this digital system, making it mandatory for companies to verify the registration status of each shipment, the circular said.
The circular also re-emphasizes the responsibility of manufacturers to comply with supplier audit and approval rules. This includes verifying the reliability of suppliers who provide materials such as glycerin, propylene glycol and sorbitol solution. Audits, if required, must assess whether suppliers can meet GMP standards, while assessments must take into account past performance and the nature of the materials supplied.
DCA warns that any negligence in following these instructions, including the earlier circular, will be viewed with utmost seriousness. In case of non-compliance, regulatory and criminal measures will be initiated against the manufacturing companies and responsible workers. The circular makes it clear that strict adherence to these guidelines is mandatory.
Published – 16 Nov 2025 19:51 IST
