Image

Telangana Cancelled Mylan's Alprazolam License Amid Unauthorized Diversion

Asia Manufacturing Review Team | Thursday, 15 February 2024

 Asia Manufacturing Review Team

The Telangana Drugs Control Administration has taken decisive action against Mylan Laboratories Ltd by revoking its product manufacturing license for the psychotropic drug Alprazolam. This move comes after authorities discovered an unauthorized diversion of Alprazolam from the company's facility in the state, raising serious concerns about potential drug abuse.

V B Kamalasan Reddy, Director General of the Telangana Drugs Control Administration, revealed that the diversion of Alprazolam was flagged by Excise authorities. This diversion, which could fuel substance abuse problems, prompted the regulatory body to cancel Mylan Laboratories Ltd's manufacturing license.

Investigations unveiled that a significant quantity of 21.250 kilograms of Alprazolam had been illicitly diverted from Mylan Laboratories Ltd Unit-7 in Sangareddy District. This diversion was facilitated by certain employees who held roles as chemists and production officers at the facility. Additionally, authorities seized an additional 4.850 kilograms of Alprazolam last February from the consumables room of the same Mylan Laboratories Ltd unit.

In response to these alarming findings, the Telangana Drugs Control Administration issued a show cause notice to Mylan Laboratories Ltd. This action was taken as the company failed to report the unauthorized diversion of Alprazolam from its licensed premises to the regulatory authority, a violation of established protocols.

The cancellation of Mylan Laboratories Ltd's product manufacturing license for Alprazolam underscores the severity of the situation and the government's commitment to combatting drug-related issues. It serves as a stern warning to pharmaceutical companies to uphold strict adherence to regulations and prevent unauthorized diversions that could contribute to substance abuse problems in society.

In light of this development, stakeholders are urged to remain vigilant and cooperative with regulatory authorities to ensure the safe and responsible manufacturing and distribution of pharmaceutical products, particularly those with potential for misuse or abuse.