Telangana Mandates Digital Registration for Essential Solvents

The Telangana Drugs Control Administration (DCA) has mandated that all essential solvents, including Glycerin, Propylene Glycol, and Sorbitol Solution, used in the production of liquid oral medicines must now be procured exclusively from suppliers registered on the national Digital Monitoring System. This directive follows tragic incidents involving child deaths linked to contaminated cough syrups in Madhya Pradesh and Rajasthan last month.

This new regulation is part of a comprehensive follow-up circular issued to all liquid oral manufacturers. It builds on a previous communication from October 13, which required testing for Diethylene Glycol and Ethylene Glycol at each stage of production. The latest advisory emphasizes the need for a mandatory digital trail for these high-risk solvents. The DCA has specified that manufacturers of these solvents must be registered on the Online National Drugs Licensing System (ONDLS) portal managed by the Central Drugs Standard Control Organisation (CDSCO).

New Compliance Requirements for Manufacturers

According to the DCA’s circular, liquid oral manufacturers can only use batches of these solvents if they originate from verified suppliers listed on the digital system. This requirement places the onus on manufacturers to ensure the registration status of every consignment. The circular also stresses the importance of adhering to supplier audit and approval processes. Manufacturers must verify the reliability of their suppliers, ensuring they meet the standards of Good Manufacturing Practices.

Audits should evaluate suppliers based on their ability to comply with these standards, taking into account their past performance and the nature of the materials supplied. The DCA has issued a stern warning regarding compliance, stating that any negligence in following these new guidelines, as well as the previous circular, will be treated seriously. Regulatory and penal actions may be initiated against manufacturing firms and responsible personnel in cases of non-compliance.

The circular makes it unequivocally clear that adherence to these instructions is not optional. As the DCA continues to enforce stricter regulations, the focus remains on ensuring the safety and quality of medicine production in the region.