Prime Highlights
- The Telangana Drugs Control Administration (TGDCA) has made DEG and EG testing mandatory at multiple stages of syrup production to prevent contamination.
- Strict penalties, including arrest and imprisonment, will be imposed on manufacturers violating the new safety regulations.
Key Facts
- All excipients like Glycerin, Propylene Glycol, and Sorbitol must be sourced from original suppliers and tested for DEG and EG upon receipt and in finished products.
- Violations may lead to prosecution under Section 27(a) of the Drugs and Cosmetics Act, 1940, with punishments ranging from 10 years to life imprisonment and fines starting at ₹10 lakh.
Background
To ensure the safety of children’s medicines, the Telangana Drugs Control Administration (TGDCA) has made it mandatory for all syrup manufacturers in the state to test for Diethylene Glycol (DEG) and Ethylene Glycol (EG) at multiple stages of production. The move comes after the deaths of children in Madhya Pradesh from DEG- and EG-contaminated cough syrups.
During a virtual meeting on October 10, the TGDCA instructed manufacturers to source excipients like Glycerin, Propylene Glycol, and Sorbitol Solution directly from original suppliers. Each container or pack of raw materials must be tested for DEG and EG on receipt, and all finished syrups must undergo the same tests before being released to the market.
Companies must maintain accurate records of all tests, even if testing is done by approved external labs. The TGDCA also recommended that manufacturers set up in-house testing facilities, including Gas Chromatographs, to ensure safety at every step.
The TGDCA said it will conduct surprise inspections to check compliance. Any negligence or violation may result in arrest and be charged under Section 27(a) of the Drugs and Cosmetics Act, 1940. This can lead to 10 years to life in prison and a fine of at least ₹10 lakh. They may also face charges under the Bharatiya Nyaya Sanhita, 2023, including laws on serious harm and drug tampering.
The new rules aim to stop harmful contamination in syrups, protect children, and improve the quality and safety of oral medicines in Telangana.
