Pregabalin formulations must be sold with prescription: Drugs Control Administration, Telangana

New Delhi: In a significant move to counter the rising abuse of pregabalin, the Drugs Control Administration (DCA) of Telangana has instructed all stakeholders, including retail outlets and hospital-attached pharmacies, that pregabalin formulations must be sold only with a prescription from a registered medical practitioner.

This move is based on reports received by the Drugs Control Administration, Telangana, regarding the abuse potential of the drug Pregabalin, and considering drug literature, including several case reports and epidemiological studies, concerns have been raised about the abuse potential of Pregabalin, the use of which has increased substantially over the last decade.

The drug 'Pregabalin' has been approved in India by the Drugs Controller General (India) for the following indications: the treatment of peripheral neuropathic pain in adults (such as diabetic neuropathy), and the management of fibromyalgia syndrome, either as a single-ingredient formulation or in a fixed-dose combination with Methylcobalamin, Alpha-lipoic Acid, Pyridoxine, and Folic Acid.

Pregabalin is an anticonvulsant drug used to treat neuropathic pain conditions and fibromyalgia, and for the treatment of partial onset seizures in combination with other anticonvulsants.

Pregabalin is structurally similar to gamma-aminobutyric acid (GABA) - an inhibitory neurotransmitter. It may be used to manage neuropathic pain, postherpetic neuralgia, and fibromyalgia among other conditions. Although, as per the FDA label, the mechanism of action has not been definitively characterized, there is evidence that pregabalin exerts its effects by binding to the α2δ subunit of voltage-dependent calcium channels. Pregabalin is marketed by Pfizer under the trade names Lyrica and Lyrica Cr (extended release). It may have dependence liability if misused but the risk appears to be highest in patients with current or past substance use disorders.

Products containing 'Pregabalin' are being manufactured and supplied by most pharmaceutical manufacturers with a boxed caution on the product label, including the primary pack (strip) and carton, stating: CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

Considering the drug literature, which includes numerous case reports and epidemiological studies, as well as reports obtained by the Drugs Control Administration, Telangana, regarding the abuse potential of the medication pregabalin—the use of which has significantly increased over the past ten years—concerns have been raised.

In light of the reports concerning the abuse potential of Pregabalin, the Drugs Control Administration, Telangana, instructs all stakeholders, including retail outlets and hospital-attached pharmacies, that Pregabalin formulations must be sold only with a prescription from a Registered Medical Practitioner.

In addition to the above, the Drugs Control Administration, Telangana, through a notice stated that the details of Pregabalin sales must be recorded in the Prescription Register at the time of supply, and the serial number of the register entry must be noted on the prescription.

The following particulars shall be entered in the 'Prescription Register' for the sale of formulations containing pregabalin:

(a) Serial number of the Entry,

(b) date of Supply,

(c) name and address of the Prescriber

(d) name and address of the Patient,

(e) name of the drug and quantity,

(f) Supplied manufacturer's name, batch number, and date of expiry of potency,

(g) Signature of the registered pharmacist who supplied the medicine or under whose supervision it was supplied.

Furthermore, the notice added, "The above instructions shall be strictly adhered to. Failure to comply with these instructions will attract punishment under the Drugs and Cosmetics Act, 1940, and the Rules made thereunder."

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