Telangana Drugs Control Administration (DCA), on Wednesday, cancelled the product manufacturing licence of global pharmaceutical company Mylan Laboratories Limited for ‘alprazolam’, a sedative used to treat anxiety and sleeping disorders.
In the order letter dated February 13, issued by DCA, a copy of which is in possession of The Hindu, P. Sarala, Deputy Director, Nizamabad Licencing Authority “cancelled the drug manufacturing licence, that was issued for the substance ‘Alprazolam’ under Form-25 bearing Licence No. 108/MD/AP/97/B/R (for all specification types) with immediate effect in the larger public interest”. This was done under Section 85(2) in The Drugs and Cosmetics Rules, 1945.
The order comes on the back of unauthorised diversion of 21.25 kilograms of the drug from the licensed premises of the pharmaceutical major in Sangareddy, Telangana, through certain employees who were working as chemists and production officers at the site, V. B. Kamalasan Reddy, Director General, DCA explained. “In connection with this, a seizure of 4.85 kilograms of alprazolam was carried out in February 2023 by Prohibition & Excise Authorities from the consumables room of the pharmaceutical major,“ he added.
“Leakage from the pharmaceutical industry is a major concern. While Mylan had the licence to manufacture alprazolam, there was no proper control over the quantity being produced and sold,” a senior official from the Telangana Excise & Prohibition Department told said. Alprazolam can be sold only by medical shops with a licence and on prescription.
According to the order, a show cause notice was given to Mylan on January 8, 2024 based on the first inspection report dated January 3, 2023. The explanation submitted by the company on January 22, 2024 was not found satisfactory, the order read.
The licence issued by DCA includes permission for the activities of manufacturing the bulk drug alprazolam (API) and supplying the drug exclusively to formulation (tablets or injections) manufacturing units.
This comes at a time when alprazolam misuse has been a major concern for the state, especially events of the drug being mixed with toddy which leads to serious health consequences including addiction, physical dependence, tolerance and withdrawal symptoms upon discontinuation. In 2023, 43 instances of alprazolam seizures have been recorded and 66 cases of selling alprazolam mixed in toddy in Hyderabad alone.
