Last Updated on April 20, 2025 by The Health Master
Pregabalin
Pregabalin, a prescription drug, is alarming as it is being misused, particularly within the state’s opioid user population, triggering a wave of concern that has reached the highest level of both state and central governments.
Alarm Bells Ring in Parliament:
The Punjab government has officially recognized the disturbing surge in the illegal use and trafficking of Pregabalin, acknowledging the gravity of the situation.
Member of Parliament Gurjeet Singh Aujla raised the matter in the Lok Sabha, bringing national attention to the insidious spread of this prescription drug’s misuse within the state.
This parliamentary intervention underscores the seriousness with which authorities are now viewing this emerging crisis.
Raids Uncover a Multi-Million Rupee Illicit Trade:
Data released by the Union Health Ministry paints a stark picture of the extent of Pregabalin’s misuse.
According to figures from the Food and Drugs Administration (Drugs Wing), Punjab, a staggering amount of Pregabalin-based drug formulations, valued at nearly ₹6 crore (₹5,97,09,785), was seized during a series of raids conducted at 72 different premises and firms between January 1st and December 31st, 2024.
This extensive operation also resulted in stringent regulatory actions, including the cancellation of licenses for 12 firms, the suspension of operations for 46 others, and the filing of 11 legal cases in court, demonstrating a firm stance against the illicit trade.
Tightening the Noose:
In a proactive response to the increasing crisis, the Punjab FDA issued a set of stringent new directives on February 28th.
These guidelines target key players in the pharmaceutical supply chain, including drug manufacturers, clearing and forwarding agents, wholesale chemists, and retail chemists.
These directives mandate that all sales and purchases of Pregabalin, including six other drugs, exceeding specified limits per invoice must now be reported to the drug control officers of the concerned area.
Regulatory Framework and Enforcement
The Union Health Ministry has clarified that the prescription drugs fall under the purview of state drug control authorities, working under the framework of the Drugs and Cosmetics Act, 1940, and Rules 1945.
These drug control authorities are empowered to conduct regular inspections, issue licenses, and take legal action against the defaulters found in violation of the regulations.
The ministry acknowledges receiving complaints regarding the sale of prescription drugs without valid prescriptions; these are swiftly forwarded to the relevant state drug control authorities for further necessary action.
Need for Consistent Regulation
Responding to concerns raised in Parliament about the absence of a uniform national policy to regulate the sale of such prescription drugs, the ministry has confirmed that this serious issue is currently under active consideration.
In this regard, an important step was taken during the 65th meeting of the Drugs Consultative Committee (DCC) held on December 20th, 2024.
The inclusion of Pregabalin in Schedule H1 of the Drugs Rules, 1945, was thoroughly discussed during the above-said meeting.
If this proposal is implemented, it would mean that Pregabalin could only be sold upon presentation of a valid prescription from a registered medical practitioner (RMP).
Focus on Retail Networks:
As Punjab intensifies its crackdown on both traditional narcotics and the growing menace of pharmaceutical drug misuse, state drug authorities are having vigilant eyes on the retail distribution network.
There is a growing concern that ongoing anti-drug campaigns, while crucial in disrupting illegal supply chains, could inadvertently lead to a greater misuse of pharmaceutical drugs as alternative substances.
Regular Inspections to Curb Unauthorised Sales
To proactively address this potential risk, authorities have been explicitly directed to ensure regular and thorough inspections of chemist shops throughout the state.
The primary objective of these inspections is to effectively curb the unauthorized sale of prescription drugs like Pregabalin and to significantly strengthen oversight at the ground level, ensuring that these medications are dispensed responsibly and only to those with legitimate medical needs.
Q. What is Pregabalin, and why is it being misused?
A. Pregabalin is a prescription drug used to treat health issues like seizures, nerve pain, and anxiety. It is being misused, mainly by opioid users, for its sedative or euphoric effects.
Q. What actions has the Punjab government taken for Pregabalin misuse?
A. The Punjab government has taken prompt action, conducted raids leading to seizures and arrests, suspended and cancelled licenses of violating firms, and issued new directives for stricter reporting of Pregabalin sales and purchases.
Q. What is Schedule H1?
A. Schedule H1 bearing a list of drugs that can only be sold on the prescription of a registered medical practitioner and requires specific record-keeping.
Q. What can be done to prevent Pregabalin misuse?
A. Prompt and stricter enforcement of prescription drug regulations, initiating awareness programs among the public and healthcare professionals regarding the potential risks of misuse of pregabalin, and regular inspections of medical stores/pharmacies towards regulating the sale of such drugs are crucial steps.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purppurposes only, it cannot be treated as medical advice. Always consult your doctor for any health issues and and/or rthe treatment of the same. The Health Master does not claim responsibility for this information.
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