Mylan Labs license to manufacture Alprazolam cancelled by Telangana DCA

According to Drug Control Administration (DCA) officials the unauthorised 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.

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 carrying out an inspection of 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.

“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 cancelled by the Drugs Control Administration, Telangana, with immediate effect, in the larger public interest,” said the Director General.

Mylan was issued a license by the DCA, Telangana, to manufacture the drug ‘Alprazolam’ (Active Pharmaceutical Ingredient). The license issued by DCA includes permission for the activities of manufacturing the bulk drug Alprazolam (API) and supplying the drug exclusively to the formulation (tablets/injections) manufacturing units.

‘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 addiction / habit-forming potential of Alprazolam is very high. The abuse of Alprazolam can lead to various adverse effects including addiction, physical dependence, tolerance and withdrawal symptoms upon discontinuation.

Misuse of Alprazolam 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 for physical and mental health, including cognitive impairment, mood disturbances, and increased risk of accidents.

There were reported events of ‘Alprazolam’ drug being mixed with toddy (adulterating toddy) which leads to serious health consequences.

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, in order to prevent abuse.

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.