Telangana DCA cancels Mylan’s Alprazolam license over unauthorised diversion

Prohibition & Excise officials seized 4.850 kilograms of Alprazolam from the consumables room of Mylan’s unit at Pashamylaram in Patancheru mandal of Sangareddy district

Hyderabad: The TS Drug Control Administration (TSDCA) on Wednesday said that it has cancelled the drug manufacturing license of Mylan Laboratories, Unit-7 at Pashamylaram, Patancheru for the drug Alprazolam.

The DCA Telangana has issued a show cause notice to Mylan Laboratories, after carrying out an inspection of its facility, as the firm failed to notify it regarding the unauthorized diversion of Alprazolam from the licensed premises. The snow cause notice was also served because of lack of adequate controls for prevention and detection of unauthorized diversion of alprazolam from the licensed premises, TSDCA said.

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Given the nature of the violations, the manufacturing license for the drug Alprazolam has been cancelled by TSDCA with immediate effect, in the larger public interest, DG, TSDCA, Kamalasan Reddy on Wednesday said.

Recently, unauthorized diversion of 21.250 kilograms of the psychotropic substance Alprazolam from Mylan Laboratories, Pashamylaram by certain employees who were working as chemists and production officers at the site was detected by Prohibition and Excise authorities.

In connection with this, a seizure of 4.850 kilograms of Alprazolam was carried out in February 2023 by Prohibition and Excise officials from the consumables room of Mylan Laboratories Ltd., Unit-7, Pashamylaram.

Alprazolam is a psychotropic substance under Narcotic Drugs and Psychotropic Substances Act (NDPS Act) and is used as a medicine to treat anxiety disorders, panic disorders, anxiety associated with depression, insomnia. The abuse of Alprazolam, however, can lead to various adverse effects including addiction, physical dependence, tolerance and withdrawal symptoms upon discontinuation.