DCA Cancel Mylan Alprazolam License Over Unauthorized Diversion 

Hyderabad, Feb 14 (Maxim News):  Telangana’s Drug Control Administration has canceled pharmaceutical major Mylan laboratories ‘ license to manufacture Alprazolam after unauthorized diversion of the psychotropic substance was detected from its unit near Hyderabad.

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According to Drug Control Administration (DCA) officials the unauthorized diversion of 21.250 kilograms of the psychotropic substance ‘Alprazolam‘ from the licensed premises of Mylan Laboratories Ltd., Unit-7, through certain employees who were working as chemists and production officers at the site, was detected by Prohibition & Excise authorities. 

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.

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DCA Director General V.B Kamalasan Reddy said on Wednesday that the event of unauthorized diversion, which could potentially lead to abuse of the drug ‘Alprazolam’, came to the notice of the Drugs Control Administration, Telangana, from the Excise authorities. 

DCA Telangana issued a show cause notice to Mylan Laboratories Unit-7 upon inspecting the site, as the firm failed to notify the DCA regarding the unauthorized diversion of Alprazolam and for certain violations reported by DCA officers regarding the lack of adequate controls for the prevention and detection of such unauthorized diversion.

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

The DCA has asked manufacturers of narcotic drugs and psychotropic substances to implement stringent measures to prevent unauthorized diversion, pilferage, or theft of the drugs they manufacture, to prevent abuse.

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Surprise raids shall be intensified on manufacturing units holding licenses to manufacture narcotic drugs and psychotropic substances to verify reconciliation data.  Stringent action shall be taken as per the law against violators, the DG added. (Maxim News) 

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