Kasaragod: A Pradhan Mantri Bhartiya Janaushadhi Kendra (PMBJK), pharmacy that sells unbranded generic drugs, was found illegally selling Pregabalin, a widely abused neurological drug, without prescriptions or maintaining the mandatory register in Kanhangad on Tuesday, March 11.

During a joint inspection by the Excise Department and Kerala’s Drugs Control Department, officials found that the pharmacy, owned and run by Sudheera P V at Padannakkad, had an unusually large stock of Pregabalin. The drug, though prescribed for nerve pain and seizures, is often misused for its euphoric and relaxing effects.

"We reviewed the purchase bills of Pregabalin for the past six months and found that they did not match the sales records," said Bijin EN, the Drug Inspector in charge of Kasaragod district.

The inspection followed a tip-off received by Kasaragod Excise Deputy Commissioner Joy Joseph alleging that Sudheera’s PMBJK was selling Pregabalin to school and college students without prescriptions. The drug had also been flagged in last month’s District Janakeeya Jagratha Samithi (People’s Monitoring Committee) meeting in Kasaragod, said Joseph.

Pregabalin is approved in India to treat nerve pain, including diabetes-related nerve damage, widespread muscle pain, and seizures. However, states such as Telangana have banned its sale without a prescription, even in combination with methylcobalamin, alpha-lipoic acid, pyridoxine, and folic acid, due to its rampant abuse.

In a September 2024 order, the Telangana Drugs Control Administration highlighted a sharp increase in Pregabalin misuse over the past decade. A pharmacist in Nileshwar confirmed this trend. "Youngsters crush the tablets or mix the capsule powder in carbonated drinks for intoxication. While students may not directly buy the drug, peddlers do, claiming it's for their sick family members," he said.

Despite carrying the label 'Not to be sold by retail without a prescription, ' Pregabalin is widely sold without oversight. During the inspection, Sudheera’s pharmacy was also found violating antibiotic record-keeping rules, a serious breach of the Drugs and Cosmetics Act, 1940, and its Rules, 1945.

As per the law, pharmacists must maintain a register with details of date of supply, name & address of the prescriber, name & address of the patient, drug name & quantity, manufacturer, batch number, and expiry date. "No such register was maintained," said Bijin.

Profits over public health?
The Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) was launched to provide affordable generic medicines through PMBJK stores, which are run by private individuals, NGOs, and institutions. To encourage entrepreneurship, the operating agency or entrepreneur is given a subsidy up to Rs 2 lakh to set up the store and is given a 20% commission on the MRP (excluding taxes) of each drug sold.

However, the lack of strict monitoring may have allowed some stores to prioritise profits over public health.

Drug Inspector Bijin said he would submit a report detailing the violations to Assistant Drugs Controller Harishkumar A, who is responsible for licensing retail and wholesale allopathic drug sales. Sudheera will receive a show-cause notice and must explain her actions. "Depending on her response, her licence could either be suspended or cancelled," said Bijin.