Telangana DCA Imposes Strict Regulations on Pregabalin Sales Amid Abuse Concerns

Hyderabad: The Drugs Control Administration (DCA) of Telangana has issued new restrictions on the sale of formulations containing Pregabalin, a drug commonly prescribed for peripheral neuropathic pain and fibromyalgia syndrome. This move comes in response to growing concerns about the drug's abuse potential.

Regulation on Sale of Pregabalin

The DCA has directed all stakeholders, including retail pharmacies and hospital-attached pharmacies, to ensure that Pregabalin formulations are only sold with a valid prescription from a Registered Medical Practitioner.

The drug, which is often prescribed in combination with Methylcobalamin, Alpha-lipoic Acid, Pyridoxine, and Folic Acid, must have a boxed caution on its label stating, "CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner."

Record-Keeping Requirements

Pharmacies are required to record detailed information about each sale of Pregabalin in a 'Prescription Register.' The details to be entered include:

- Serial number of the entry

- Date of supply

- Name and address of the prescriber

- Name and address of the patient

- Name of the drug and the quantity

- Name of the manufacturer, batch number, and date of expiry

- Signature of the registered pharmacist who supplied the medicine

Dr. V.B. Kamalasan Reddy, IPS, Director General of the DCA, emphasized, "Strict adherence to these regulations is necessary to prevent the misuse of Pregabalin. Non-compliance will result in penalties under the Drugs and Cosmetics Act, 1940."

Response to Abuse Concerns

The decision to impose these restrictions follows reports received by the DCA regarding the increasing abuse of Pregabalin. The drug's potential for misuse has been documented in various case reports and epidemiological studies, prompting the DCA to take action to control its distribution.

Instructions for State Officials

The DCA has instructed all Drugs Inspectors in Telangana to circulate this notice to all retail outlets, including hospital-attached pharmacies. Inspections will be carried out to verify compliance with the new regulations.