Pharma firm Mylan’s product manufacturing licence for psychotropic drug ‘Alprazolam’ cancelled

The Telangana Drugs Control Administration on Wednesday said it has canceled the product manufacturing license of Mylan Laboratories Ltd for the drug ‘Alprazolam’ after an allegedly “unauthorized” diversion of the psychotropic drug was detected from its unit in the state. The unauthorised diversion, which could potentially lead to abuse of the addictive drug ‘Alprazolam’, came to the notice of the Drugs Control Administration, Telangana, from Excise authorities, DCA Director General V B Kamalasan Reddy said in a release.

The Telangana Drugs Control Administration (DCA) said that Prohibition and Excise authorities had found that 21.250 kilogram of Alprazolam was diverted, “unauthorized”, from the licensed premises of Mylan Laboratories Ltd Unit-7, at Sangareddy District, through certain employees who were working as chemists and production officers.

In a related incident, 4.850 kilogram of Alprazolam had been seized in February last year by Prohibition and Excise authorities from the “consumables room” of Mylan Laboratories Ltd Unit-7, they said.

DCA Telangana issued a show cause notice to Mylan Laboratories Ltd, upon carrying out an inspection of the site, as the firm “failed” to notify the Telangana DCA of the alleged “unauthorized” diversion of Alprazolam from its licensed premises.

The notice was issued also over certain violations reported by DCA officers regarding the lack of adequate controls for the prevention and detection of such “unauthorised” diversion, an official said.

“Considering the nature of the violations reported regarding the drug ‘Alprazolam’, which is a psychotropic substance, and its unauthorised diversion from Mylan Laboratories Ltd., Unit-7, upon assessment of the existing controls and practices at the site, the manufacturing licence for the drug ‘Alprazolam’ has been canceled by the Drugs Control Administration, Telangana, with immediate effect, in the larger public interest,” the DCA Director General said.

The licence held Mylan Laboratories Ltd Unit-7, Pashamylaram, Patancheru Mandal, Sangareddy District had been for the manufacture of the drug ‘Alprazolam’ (Active Pharmaceutical Ingredient).

The licence issued by the Telangana DCA had included permission for the activities of manufacturing the bulk drug Alprazolam (API) and supplying the drug exclusively to the formulation (tablets/injections) manufacturing units, the release said.

‘Alprazolam’ is a psychotropic substance under the Narcotic Drugs and Psychotropic Substances Act (NDPS Act) and is used as a medicine to treat anxiety disorders, panic disorders, anxiety associated with depression and insomnia. The addiction/habit-forming potential of Alprazolam is very high.

The abuse of Alprazolam can lead to various adverse effects including addiction, physical dependence, and withdrawal symptoms upon discontinuation, the release added.