Telangana Drug Control Administration revokes product manufacturing licence of Mylan Laboratories

HYDERABAD: The Telangana Drugs Control Administration (DCA) on Wednesday cancelled the product manufacturing license of Mylan Laboratories Ltd. based in Pashamylaram Patancheru Mandal, Sangareddy district, for the drug 'Alprazolam'.

Mylan Laboratories Ltd. with its registered office at Unit-7, Pashamylaram, Patancheru Mandal, Sangareddy District, obtained a license from the Drugs Control Administration, Telangana, to manufacture the drug 'Alprazolam' (Active Pharmaceutical Ingredient). This license included the permission to manufacture the bulk drug alprazolam (API) and supplied it exclusively to production units for formulations (tablets/injections).

Alprazolam' is categorised as a psychotropic substance under the Narcotic Drugs and Psychotropic Substances Act (NDPS Act) and is commonly prescribed for a range of conditions such as anxiety disorders, panic disorders, anxiety associated with depression, and insomnia. However, its high potential for addiction and habit formation has raised significant concerns within the medical community. Misuse of Alprazolam can lead to addiction, physical dependence, tolerance, and withdrawal symptoms upon cessation.

The misuse of Alprazolam can result in various adverse effects, including sedation, drowsiness, dizziness, confusion, impaired coordination, memory problems, and respiratory depression, especially when combined with alcohol or other central nervous system depressants. Prolonged abuse of Alprazolam can have severe repercussions for physical and mental health, including cognitive impairment, mood disturbances, and an increased risk of accidents.

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Instances have been reported where 'Alprazolam' was adulterated with toddy, leading to serious health consequences.

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. In connection with this, Prohibition & Excise Authorities seized 4.850 kilograms of Alprazolam in February 2023 from the consumables room of Mylan Laboratories Ltd., Unit-7.

The Drugs Control Administration, Telangana, learned about the unauthorised diversion, which could potentially lead to the abuse of the drug 'Alprazolam', through the Excise Authorities.

Following an inspection of the site, the DCA Telangana issued show cause notice to Mylan Laboratories Ltd, Unit-7, to submit an explanation as the company had failed to inform the Drug Control Authority about the unauthorised diversion of Alprazolam from the licensed premises. DCA officials also found certain violations involving the lack of adequate controls to prevent and detect such illicit diversion.

Given the seriousness of the reported violations involving the psychotropic substance 'Alprazolam' and its illicit diversion from Mylan Laboratories Ltd, Unit-7, and after evaluating the existing controls and practices at the site, the Drug Control Authority has revoked the manufacturing license for the drug 'Alprazolam' in the larger public interest with immediate effect.

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Manufacturers of narcotics and psychotropic substances are required to take stringent measures to prevent the unauthorized diversion, theft or pilferage of the drugs they manufacture to prevent misuse.

Surprise raids on manufacturing units holding licenses to manufacture narcotic drugs and psychotropic substances will be intensified to verify reconciliation data, and stringent action will be taken against violators as per the law.