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Industry specific-Medical Telangana Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Telangana Drugs Control Administration Issues Directions on Diethylene Glycol (DEG) and Ethylene Glycol (EG) Testing in Liquid Oral Formulations

13-Oct-2025 | 28/DG-Peshi/2025

As per the issued circular direction are given to all Liquid Oral Manufacturers in the State to implement stringent quality control measures to prevent contamination of liquid oral formulations, following recent child fatalities in Madhya Pradesh suspected to be caused by adulteration in cough syrups. As per the circular, manufacturers must: 1. Procure excipients such as Glycerin, Propylene Glycol, and Sorbitol Solution only from original manufacturers and ensure they meet pharmacopoeial standards. 2. Test all raw materials and finished liquid oral products for DEG and EG content before use, ensuring levels do not exceed 0.10 percent as per the Indian Pharmacopoeia 2022. 3. Maintain data integrity and submit test reports to the Directorate of Drugs Control Administration and respective Drugs Inspectors. 4. Preferably conduct in-house testing using Gas Chromatography to ensure accuracy. Any non-compliance, adulteration, or lapse leading to adverse health incidents will invite stringent penal action, including prosecution. Please refer to the attached circular for detailed compliance requirements.

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