Telangana pharma firm loses licence to make alprazolam after unauthorised diversion detected
The drugs Control Administration (DCA) of telangana has revoked Mylan Laboratories' license to produce alprazolam following the discovery of an unlawful diversion of the psychotropic drug at the company's facility close to Hyderabad.
The DCA announced on wednesday that, in light of the infractions and following an evaluation of the current controls and procedures on the licensed premises of the company's unit 7 in Pashamylaram, sangareddy district, the drug's production license was revoked with immediate effect.
The DCA announced on wednesday that, in light of the infractions and following an evaluation of the current controls and procedures on the licensed premises of the company's unit 7 in Pashamylaram, sangareddy district, the drug's production license was revoked with immediate effect.
The DCA reported that 21.25 kg of alprazolam had been unlawfully diverted from the location, as discovered by prohibition and excise officials. A memo from the DCA's director-general, VB Kamalasan Reddy, states that the chemists and manufacturing officials employed at the location carried out this alprazolam diversion. It further stated that 4.85 kg of the medicine were taken this month from the unit's consumables room.
According to Reddy, the company neglected to tell the DCA about the unapproved diversion of alprazolam from its licensed premises, so inspectors conducted an inspection of the plant and issued a show-cause notice. The authorities also observed a few additional infractions, including as the absence of sufficient safeguards against the unlawful diversion of alprazolam and their identification.
According to Reddy, the company neglected to tell the DCA about the unapproved diversion of alprazolam from its licensed premises, so inspectors conducted an inspection of the plant and issued a show-cause notice. The authorities also observed a few additional infractions, including as the absence of sufficient safeguards against the unlawful diversion of alprazolam and their identification.
The DCA believed that such an unauthorized diversion may result in drug misuse. Permission to produce alprazolam (API) in bulk and distribute it solely to facilities producing tablets and injections was part of the DCA licensing.
Alprazolam is a psychotropic medication covered by the Narcotic drugs and Psychotropic Substances Act. It is used to treat a variety of conditions, including anxiety disorders, panic attacks, depression-related anxiety, sleeplessness, and more. Abuse of it, however, can result in physical dependency, addiction, and withdrawal symptoms when stopped. Long-term abuse can have a serious negative impact on a person's mental and physical well-being. It can also lead to mood swings, cognitive decline, and an elevated risk of accidents.
Alprazolam is a psychotropic medication covered by the Narcotic drugs and Psychotropic Substances Act. It is used to treat a variety of conditions, including anxiety disorders, panic attacks, depression-related anxiety, sleeplessness, and more. Abuse of it, however, can result in physical dependency, addiction, and withdrawal symptoms when stopped. Long-term abuse can have a serious negative impact on a person's mental and physical well-being. It can also lead to mood swings, cognitive decline, and an elevated risk of accidents.
The DCA has ordered producers of certain psychotropic and narcotic pharmaceuticals to put strict controls in place to guard against drug theft, pilferage, and unlawful diversion. It has alerted license units about the possibility of unexpected searches to confirm reconciliation data.