Hyderabad: Officials from the Drugs Control Administration (DCA), Telangana raided unlicensed manufacturing facilities on the outskirts of Hyderabad, uncovering the illicit production of the drug ‘Diacerein’ in a chemical factory without a drug license. They seized stocks worth 50.25 lakhs during the operation.
The surprise raids took place on Thursday and Friday, with two special teams constituted by DCA Telangana for the operation.
During the raid at Rakshit Drugs, Unit II, in Bonthapally village, Gummadidala Mandal, Sangareddy district, DCA officers detected unlicensed manufacturing of ‘Diacerein.’ It was revealed that Rakshit Drugs’ manufacturing facility at Bonthapally lacked a drug manufacturing license.
In the production area of the firm, DCA officials found nine drums of yellow-colored powder labeled as ‘CDE-I.’ Upon verification of the Route of Synthesis (ROS) and Batch Manufacturing Records, it was confirmed that the material labeled as CDE-I is the drug ‘Diacerein.’
V.B. Kamalasan Reddy, Director of DCA, stated, “Rakshit Drugs Unit II has manufactured and sold several batches of the drug ‘Diacerein’ under the code name ‘CDE-I’ without a drug license.”
The officials also noted that the firm operated as an unlicensed manufacturing facility without implementing ‘Good Manufacturing Practices’ (GMP). According to the Drugs and Cosmetics Act, drugs should be manufactured in ISO-8 Clean Rooms adhering to GMP. However, the firm was found to be manufacturing ‘Diacerein’ without adhering to GMPs and without a drug license.
GMP regulations ensure the minimum requirements for methods, facilities, and controls used in manufacturing, processing, and packing of drugs, guaranteeing the safety of drugs for patient use.