Punjab Seizes Pregabalin Worth ₹5.97 Crore Amid Rising Abuse, Health Minister Informs Lok Sabha

New Delhi, April 4 – The Food and Drugs Administration (FDA) of Punjab seized pregabalin-based drug formulations worth ₹5.97 crore during raids conducted at 72 premises last year, Union Health Minister J.P. Nadda informed the Lok Sabha on Friday.

Pregabalin, a neurological drug commonly prescribed for epilepsy, has emerged as a substance of abuse in several regions. While it offers legitimate therapeutic benefits, its misuse for recreational purposes has raised significant concerns among regulatory authorities.

Crackdown on Violators: Legal and Administrative Action Taken​

In a written response, Minister Nadda highlighted the regulatory measures taken by the Punjab government to curb the growing misuse and trafficking of pregabalin. As part of this crackdown:

• Licenses of 12 pharmaceutical firms were cancelled
• Licenses of 46 firms were suspended
• 11 court complaints were filed

He emphasized that the state is actively monitoring the situation, following increasing incidents of misuse and illegal distribution.

Mandatory Reporting Introduced for High-Volume Drug Sales​

On February 28, the FDA of Punjab issued new directives to all drug manufacturers, clearing and forwarding agents, as well as wholesale and retail chemists. The order mandates the submission of detailed reports for the sale and purchase of pregabalin and six other specified drugs. Any transaction exceeding a fixed threshold per invoice must now be reported to the designated drugs control officers.

Regulatory Framework and National Oversight​

Drug sale and distribution across India are governed by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. These are enforced through a robust system of licensing and inspection managed by State Licensing Authorities (SLAs).

Minister Nadda acknowledged that isolated complaints regarding the unauthorized sale of prescription drugscontinue to surface. These cases are forwarded to SLAs for necessary action.

Consideration to Add Pregabalin to Schedule H1​

The issue of pregabalin misuse was also taken up during the 65th meeting of the Drugs Consultative Committee (DCC), held on December 20, 2024. The committee, which advises both central and state governments along with the Drugs Technical Advisory Board (DTAB), discussed the possibility of including pregabalin under Schedule H1 of the Drugs Rules, 1945. Such a move would restrict its sale only on prescriptions issued by Registered Medical Practitioners, enabling tighter control and traceability.