Telangana cancels license of Mylan Lab’s unit following unauthorised use of Alprazolam

Hyderabad: Telangana’s Drug Control Administration (DCA) had cancelled the license of one of the units of Mylan Laboratories Ltd to manufacture drug ‘Alprazolam’ an Active Pharmaceutical Ingredient (API).

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 cancellation of the product manufacturing license is followed by  the unauthorized diversion of 21.250 kilograms of 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, detected by Prohibition & Excise (P&E) Authorities.

In connection with this, P & E sleuths seized 4.850 kilograms of Alprazolam from the consumables room of Mylan Laboratories Ltd, Unit-7, recently.

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 Ltd, Unit-7, upon carrying out an inspection of the site, as the firm failed to notify the them regarding the unauthorized diversion of Alprazolam from the licensed premises and for certain violations reported by DCA officers regarding the lack of adequate controls for the prevention and detection of such unauthorized diversion of Alprazolam from the licensed premises.

“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 licence for the drug ‘Alprazolam’ has been cancelled by the Drugs Control Administration, Telangana, with immediate effect, in the larger public interest,” said  DCA, director general VB  Kamalasan Reddy.

He said that manufacturers producing narcotic drugs and psychotropic substances must implement stringent measures to prevent unauthorized diversion, pilferage, or theft of the drugs they manufacture, in order to prevent abuse.

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 which leads to serious health consequences, he said.