DCA cancels Mylan’s permission to manufacture Alprazolam: Telangana

Alprazolam falls under the category of psychotropic substances as defined by the Narcotic Drugs and Psychotropic Substances Act.

The Health Master

February 16, 2024

134

Drugs Control Administration DCA Telangana — DCA Telangana

Table of Contents

Last Updated on February 28, 2024 by The Health Master

Alprazolam

The Telangana Drugs Control Administration (DCA) recently made headlines by canceling the Alprazolam manufacturing permission of Mylan Laboratories Ltd’s unit-7.

This drastic action was taken due to the unauthorised diversion of the psychotropic drug from the licensed premises of the said unit.

Let’s delve into the details and understand the implications of this regulatory decision.

Follow us on WhtasApp Channel

Unearthing the Unauthorized Diversion

Discovery by Prohibition & Excise Authorities

In a surprising turn of events, Prohibition & Excise Authorities detected the unauthorized diversion of 21.25 kg of the psychotropic substance from Mylan Laboratories Ltd, unit-7, located in Pantancheru mandal, Sangareddy.

The discovery unfolded through the actions of certain employees working as chemists and production officers at the site.

Seizure of Alprazolam in February 2023

In response to the unauthorized diversion, a seizure of 4.85 kg of Alprazolam took place in February 2023, conducted by Prohibition & Excise Authorities.

This event marked a significant step in addressing the illicit activities surrounding the manufacturing unit.

Click for Guidance documents for industry

Show Cause Notice Issued to Mylan Laboratories Ltd

Following the discovery, the DCA issued a show cause notice to Mylan Laboratories Ltd.

The notice pointed out the company’s failure to notify the DCA regarding the unauthorised diversion, sparking concerns about compliance and transparency in pharmaceutical operations.

Nature of Violations

Failure to Notify DCA about the Unauthorized Diversion

One of the primary reasons for the permission cancellation was Mylan Laboratories Ltd’s failure to promptly inform the DCA about the unauthorized diversion.

The lack of transparency in such matters raises questions about the company’s adherence to regulatory protocols.

Click for more Articles on Pharmaceuticals

Click for more Legal Articles on Pharmaceuticals

Decision to Cancel the Manufacturing permission by DCA

Considering the nature of the violations, the DCA took the bold step of Mylan Laboratories unit-7’s manufacturing permission.

This decision underscores the severity of the situation and the need for pharmaceutical companies to ensure strict compliance with regulations.

Alprazolam: A Psychotropic Substance

Classification under the Narcotic Drugs and Psychotropic Substances Act

Alprazolam falls under the category of psychotropic substances as defined by the Narcotic Drugs and Psychotropic Substances Act.

This classification signifies its potent nature and the regulatory measures in place to monitor its production, distribution, and usage.

Click for more article on DCA Telangana

Medicinal Uses and Treatment Areas

Despite its potential for misuse, Alprazolam serves crucial medicinal purposes.

It is commonly prescribed to treat anxiety, panic disorders, and anxiety associated with depression.

Additionally, it is used to address insomnia, providing relief to individuals grappling with sleep-related issues.

Risks Associated with Misuse

However, misuse of Alprazolam can lead to adverse effects, including sedation, drowsiness, dizziness, confusion, impaired coordination, memory problems, and respiratory depression.

The dangers escalate when combined with alcohol or other central nervous system depressants.

Long-term abuse can result in serious consequences, such as cognitive impairment, mood disturbances, and an increased risk of accidents.

Consequences of Alprazolam Abuse

Short-term Effects on the Central Nervous System

The short-term effects of Alprazolam abuse are profound, affecting the central nervous system.

Users may experience sedation, drowsiness, and impaired cognitive function, highlighting the importance of responsible and regulated use.

Long-term Implications on Physical and Mental Health

Beyond immediate effects, long-term abuse of Alprazolam poses significant threats to physical and mental health.

Users may encounter cognitive impairment, mood disturbances, and an elevated risk of accidents, emphasizing the need for strict control over its distribution.

Regulatory Perspective

DCA’s Emphasis on Stringent Measures by Manufacturers

In response to the permission cancellation, VB Kamalsan Reddy, the Director General of DCA, emphasized the necessity for manufacturers to implement stringent measures.

These measures aim to prevent unauthorized diversion, pilferage, or theft of the drugs they manufacture, ensuring the prevention of potential abuse.

Director General’s Warning and Future Surprise Raids

VB Kamalsan Reddy issued a stern warning, indicating that more surprise raids could be on the horizon.

The regulatory body is committed to taking stringent action against violators, reinforcing the importance of adherence to regulations within the pharmaceutical industry.

Mylan Laboratories’ Licensing History

Issuance of permission for Alprazolam Manufacturing

Mylan Laboratories unit-7 was granted a permission by the DCA to manufacture Alprazolam in the past.

The license included permission for activities involving the manufacturing of the bulk drug and supplying it exclusively to the formulation (tablets/injections) manufacturing units.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.