Drug Controller Cancels Mylan’s Licence to Produce Alprazolam

Hyderabad: The TS Drugs Control Administration (DCA) has cancelled the product manufacturing licence of the Mylan Laboratories’ factory in Sangareddy for manufacturing alprazolam in bulk quantity in various forms and diverting it in the market unauthorisedly.

The unauthorised diversion of 21.25 gram of alprazolan, a psychotropic substance, from the licensed premises of Mylan’s Unit-7 through certain employees was detected by prohibition and excise authorities, DCA Director-General V.B. Kamalasan Reddy said on Wednesday.

He said that 4.85 gm of alprazolam was seized in February 2023 from the consumables room of Mylan’s Unit-7.
The DCA was tipped off about the unauthorised diversion of ‘Alprazolam’ by the excise authorities.

Kamalasan Reddy said the DCA issued a show-cause notice to the Unit-7 of Mylan Laboratories, as it had failed to notify the diversion of alprazolam from the licensed premises.

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 and insomnia among others.

While the addiction potential of alprazolam is very high, its abuse can lead to various adverse effects including physical dependence, tolerance and withdrawal symptoms upon discontinuation.