Telangana DCA imposes strict controls on Pregabalin sales due to abuse
Hyderabad: The Telangana Drugs Control Administration has issued a public notice imposing new restrictions on the sale of medications containing Pregabalin. This decision follows increasing concerns over the abuse potential of the drug.
Pregabalin, which is approved by the Drugs Controller General (India) for treating peripheral neuropathic pain and managing fibromyalgia syndrome, can be found in both single-ingredient formulations and fixed-dose combinations with Methylcobalamin, alpha-lipoic acid, Pyridoxine, and Folic Acid. Despite its therapeutic benefits, the substance has been linked to a rising trend in abuse, prompting the Telangana Drugs Control Administration to enforce stricter regulations.
According to the new directive, all Pregabalin formulations must be sold exclusively with a prescription from a Registered Medical Practitioner. Retail outlets and hospital-attached pharmacies are required to maintain detailed records of these sales in a Prescription Register. The following details must be recorded for each transaction:
1. Serial number of the entry
2. Date of supply
3. Name and address of the prescriber
4. Name and address of the patient
5. Name of the drug and the quantity supplied
6. Name of the manufacturer, batch number, and expiry date
7. Signature of the registered pharmacist who supplied the medication or supervised its supply
The Telangana Drugs Control Administration has said that these instructions must be strictly followed. Non-compliance with these regulations will result in penalties under the Drugs and Cosmetics Act, 1940, and the associated Rules.
The new measures are aimed at curbing the misuse of Pregabalin and ensuring its use remains within the bounds of medical necessity.
The public is encouraged to report any suspected drug manufacturing activities, including those involving narcotic drugs and psychotropic substances, in residential, commercial, or industrial areas. Any other complaints regarding illegal activities concerning medicines can also be reported. One can contact the Drugs Control Administration, Telangana, on their toll-free number 1800-599-6969. The helpline is operational from 10:30 a.m. to 5:00 p.m. on all working days.
