Stricter regulations for Liquid Oral Formulations imposed in Telangana following fatalities
Hyderabad: In the wake of tragic child fatalities in Madhya Pradesh linked to contaminated cough syrups, Telangana's Drugs Control Administration (DCA) has stepped up with stringent new measures aimed at ensuring the safety of liquid oral formulations across the state. The directive, issued after a virtual meeting with all liquid oral manufacturers on October 10, 2025, places a strong focus on the testing of raw materials and finished products for Diethylene Glycol (DEG) and Ethylene Glycol (EG), substances found to have caused recent health scares.
The most crucial measure in the directive mandates that manufacturers to test all raw materials, such as Glycerin, Propylene Glycol, and Sorbitol Solution, for DEG and EG before their use in manufacturing. The limit shall not exceed 0.10% as per the respective pharmacopoeial monographs.
In addition, all liquid oral finished products must be tested for Diethylene Glycol (DEG) and Ethylene Glycol (EG) as per the amendment to the Indian Pharmacopoeia 2022 dated 10.10.2025, without fail, with the permissible limit not exceeding 0.10%.
They are also instructed to procure pharmaceutical aids or excipients such as Glycerin, Propylene Glycol, Sorbitol Solution, etc., mandatorily directly from the manufacturers. All raw materials shall comply with pharmacopoeial standards, and only pharmacopoeial grade excipients shall be used in production.
As an abundant precaution, manufacturers shall sample and test all the individual containers or packs of Glycerin, Propylene Glycol, Sorbitol Solution, and other excipients upon receipt of raw materials.
As part of the enhanced safety protocols, manufacturers are urged to conduct in-house testing for DEG and EG by arranging Gas Chromatographs in their own Quality Control sections.
The DCA also announced that surprise inspections would be carried out at manufacturing facilities to ensure compliance with these requirements. Moreover, firms must ensure and be able to demonstrate that actual testing has been carried out and that data integrity is maintained for all test reports relating to DEG and EG content. The test reports for DEG and EG shall be periodically submitted to the Directorate of Drugs Control Administration, with a copy marked to the concerned Drugs Inspector, without fail.
The DCA has made it clear that any non-conformity or lapse in ensuring product quality leading to adverse events will attract stringent action, including the arrest and prosecution of the manufacturers and the responsible technical staff under Section 27(a) of the Drugs and Cosmetics Act, 1940, which is punishable with imprisonment for a term of not less than ten years, extendable to life imprisonment, and a fine of not less than ten lakh rupees.
Additionally, action may be initiated under Section 105 (Culpable Homicide Not Amounting to Murder) and Section 276 (Adulteration of Drugs) of the Bharatiya Nyaya Sanhita, 2023, in the event of any adverse incidents.
