After cough syrup deaths, Telangana makes digital registration mandatory for procuring essential solvents

A month after child deaths linked to contaminated cough syrups were reported in Madhya Pradesh and Rajasthan, the Telangana Drugs Control Administration (DCA) has issued a fresh directive stating that every batch of essential solvents such as Glycerin, Propylene Glycol, Sorbitol Solution used in manufacturing liquid oral medicines must be procured exclusively from suppliers registered on the national Digital Monitoring System. The instruction forms part of a detailed follow-up circular issued to all liquid oral manufacturers. 

The circular builds on an earlier communication issued on October 13 which made testing for Diethylene Glycol and Ethylene Glycol compulsory at every stage of manufacture.

A key direction in the latest advisory concerns the mandatory digital trail for the above mentioned high-risk solvents. The DCA has stated that manufacturers of these solvents must be registered under the Digital Monitoring System on the Online National Drugs licensing system (ONDLS) portal of the Central Drugs Standard Control Organisation (CDSCO). Liquid oral manufacturers may use batches of such solvents only if they originate from entities listed on this digital system, making it binding for companies to verify the registration status of every consignment, the circular said.

The circular also reiterates the responsibility of manufacturers to follow supplier audit and approval rules. This includes verifying the reliability of suppliers who provide materials such as glycerin, propylene glycol and sorbitol solution. Audits, when required, must assess whether suppliers can meet Good Manufacturing Practice standards, while evaluations must consider past performance and the nature of materials supplied.

The DCA has cautioned that any negligence in following these directions, including the earlier circular, will be viewed with the utmost seriousness. Regulatory and penal action will be initiated against manufacturing firms and responsible personnel in cases of non-compliance. The circular makes it clear that strict adherence to these instructions is mandatory.