Telangana mandates 100 per cent DEG, EG testing for all oral syrups
The Telangana Drug Control Administration has made testing for toxic solvents Diethylene Glycol and Ethylene Glycol mandatory in all oral liquid drugs. The move strengthens quality checks after recent syrup-related deaths, warning strict legal action for violations
Hyderabad: Telangana Drug Control Administration (TGDCA) has made it mandatory for all oral liquid drug manufacturers in the State to conduct checks for the deadly industrial solvent Diethylene Glycol (DEG) and Ethylene Glycol (EG) at multiple stages of drug production.
Following the tragic deaths of children in Madhya Pradesh after consuming cough syrups contaminated with DEG and EG, the TGDCA has directed pharma companies to procure pharmaceutical excipients like Glycerin, Propylene Glycol, and Sorbitol Solution from original manufacturers to eliminate potential points of adulteration.
Manufacturers must not only use pharmacopoeial-grade raw materials but also test each container or pack of these excipients for DEG and EG upon receipt. All finished liquid oral formulations, including cough and cold syrups, must be tested for DEG and EG before release. Firms must be able to demonstrate and maintain data integrity for all test reports, especially when testing is outsourced to approved laboratories, the directive said.
Manufacturers were also recommended to establish in-house testing capability for DEG and EG by installing Gas Chromatographs in their Quality Control sections. The TGDCA said it would intensify oversight by conducting surprise inspections of all manufacturing facilities to verify strict adherence to the new norms.
“Non-conformity or negligence leading to product quality lapses will result in arrest and prosecution of both the manufacturers and the responsible technical staff. Action will be initiated under Section 27(a) of the Drugs and Cosmetics Act, 1940, which carries a punishment of imprisonment for a term of not less than ten years, extendable to life imprisonment, and a fine of not less than ten lakh rupees,” the TGDCA said.
Additionally, in case of adverse incidents, action may be initiated under Bharatiya Nyaya Sanhita, 2023, specifically citing Section 105 (Culpable Homicide Not Amounting to Murder) and Section 276 (Adulteration of Drugs).
