Hyderabad: All pharma companies will henceforth conduct mandatory tests for the deadly industrial solvents Diethylene Glycol (DEG) and Ethylene Glycol (EG), the Telangana Drug Control Administration (DCA) has announced.
The directive was issued following the deaths of around 20 children in Madhya Pradesh after they consumed Coldrif cough syrup, which contained DEG and EG.
Companies should 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,” the DCA said.
It further said that all finished syrups, 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.
“Non-conformity or negligence leading to product quality lapses will result in arrest and prosecution of both the manufacturers and the responsible technical staff,” the DCA said.
The administration warned that action will be initiated under Section 27(a) of the Drugs and Cosmetics Act, 1940, against violators. The Act 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 Rs 10 lakh.
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