Government of Telangana’s Drugs Control Administration Busts Unlicensed Drug Manufacturing Facility
Hyderabad January 05
In a recent operation, officials from the Drugs Control Administration (DCA) in Telangana raided an unlicensed manufacturing facility on the outskirts of Hyderabad. The surprise raids, conducted on January 4th and 5th, 2023, targeted Rakshit Drugs Pvt. Ltd., Unit II, located in Bonthapally Village, Gummadidala Mandal, Sangareddy District.
During the raid, two special teams constituted by DCA discovered that Rakshit Drugs was involved in the unlicensed manufacturing of the drug ‘Diacerein.’ This chemical factory lacked a proper drug manufacturing license, a violation of the Drugs and Cosmetics Act.
DCA officers found nine drums containing a yellow-colored powder labeled as ‘CDE-I’ in the production area. Upon verification of the Route of Synthesis (ROS) and Batch Manufacturing Records, it was revealed that ‘CDE-I’ was, in fact, the drug ‘Diacerein.’ The firm had produced and sold several batches of Diacerein without the necessary drug license.
Further investigations disclosed that Rakshit Drugs Pvt. Ltd., Unit II, failed to adhere to Good Manufacturing Practices (GMP). According to the Drugs and Cosmetics Act, drugs should be manufactured in ISO-8 Clean Rooms with GMP compliance to ensure patient safety. The absence of GMPs in the unlicensed facility raised concerns about the quality of the manufactured drug.
A total of 236 kgs of Diacerein, valued at 50.25 lakhs, was seized by DCA officers during the raid. M. Anish Kalyan, Assistant General Manager of Rakshit Drugs Pvt. Ltd., Unit II, was present during the operation.
Diacerein, an Active Pharmaceutical Ingredient (API), is commonly used in the formulation of drugs to treat Osteoarthritis.
The raid was led by Assistant Director P. Ramu, along with Drugs InspectorsG. Srikanth, K. Anvesh, Ch. Karthik Siva Chaitanya, and A.N. Kranthi Kumar.
The DCA emphasized the importance of Good Manufacturing Practices (GMP) in drug manufacturing, underscoring their role in ensuring drug safety for patients. Unlicensed facilities pose serious risks, including contamination and deviations from quality standards.
V.B. Kamalasan Reddy, IPS, the Director General of DCA, Telangana, stated that further investigations would be carried out, and legal actions would be taken against all offenders. The intensified surveillance on chemical and intermediate factories in the state aims to curb unlicensed drug manufacturing, with stringent actions planned for violators, including imprisonment up to five years as per the Drugs and Cosmetics Act.
