DCA cancels Mylan’s licence to manufacture Alprazolam – ET HealthWorld | Pharma

Hyderabad: The Telangana Drugs Control Administration ,DCA) on Wednesday canceled the Alprazolam manufacturing license of Mylan Laboratories Ltd‘s unit -7 for unauthorized diversion of the psychotropic drugs,

“The unauthorized diversion of 21.25 kg of the psychotropic substance from the licensed premises of Mylan Laboratories Ltd, unit-7 (in Pantancheru mandal, Sangareddy) through certain employees who were working as chemists and production officers at the site was detected by Prohibition & Excise Authorities. In connection with this, a seizure of 4.85 kg of Alprazolam was carried out in February 2023 by Prohibition & Excise Authorities,” a release issued by DCA stated. The regulatory body, subsequently, issued a show cause notice to Mylan for its failure to “notify the DCA regarding the unauthorized diversion”.

But considering the nature of the violations, DCA has decided to cancel the unit’s manufacturing license.

Alprazolam is a psychotropic substance under Narcotic Drugs and Psychotropic Substances Act and is used as a medicine to treat anxiety, panic disorders, anxiety associated with depression, insomnia. Its misuse can result in sedation, drowsiness, dizziness, confusion, impaired coordination, memory problems, and respiratory depression, particularly when combined with alcohol or other central nervous system depressants. Long-term abuse of Alprazolam can have serious consequences on physical and mental health, including cognitive impairment, mood disturbances, and increased risk of accidents.

“Manufacturers must implement stringent measures to prevent unauthorized diversion, pilferage, or theft of the drugs they manufacture, in order to prevent abuse,” stated VB Kamalsan Reddy, director general of DCA warning of more surprise raids in the future. “Strict action shall be taken against violators,” he added.

Mylan Laboratories unit-7 was issued a license by the DCA to manufacture Alprazolam in the past. The license included permission for activities of manufacturing the bulk drug and supplying it exclusively to the formulation (tablets/injections) manufacturing units.

  • Published On Feb 15, 2024 at 12:05 PM IST

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