Pregabalin, a commonly prescribed medicine used for nerve pain, epilepsy and certain neurological disorders, will no longer be available over the counter (OTC). The Union Health Ministry has brought the drug under stricter regulatory control following growing reports of misuse and illegal sale, particularly among youth.
The Ministry has notified the inclusion of Pregabalin under Schedule H1 of the Drugs Rules, 1945 — a category reserved for medicines requiring tighter monitoring because of their potential for abuse and public health risks.
With the revised classification, chemists will now be allowed to sell Pregabalin only against a valid prescription issued by a registered medical practitioner. Pharmacies will also have to maintain separate records of prescriptions and sales, while manufacturers have been directed to print mandatory Schedule H1 warning labels prominently on medicine packaging.
The decision comes after several States reported instances of unauthorised stocking, illegal distribution and recreational misuse of the medicine. Enforcement agencies have also seized large quantities of illegally stocked Pregabalin from different parts of the country in recent months.
Pregabalin is widely prescribed for neuropathic pain associated with diabetes, spinal cord injuries and nerve damage. It is also used in the treatment of fibromyalgia, epilepsy and certain anxiety-related disorders. However, health authorities say the medicine has increasingly been misused because of its sedative and euphoric effects when consumed without medical supervision or in excessive doses.
Officials said the tighter regulation is intended to prevent easy access to the medicine and improve prescription monitoring across the pharmaceutical supply chain.
“The measure is aimed at strengthening accountability across the supply chain, preventing unauthorised access, enhancing prescription monitoring, curbing illegal trafficking, and safeguarding public health from drug misuse and abuse,” the Health Ministry said.
Under the new rules, retailers will be required to maintain detailed registers recording the name of the prescribing doctor, patient details and quantity of the drug sold. Failure to comply with the provisions may attract penal action under the Drugs and Cosmetics Act, 1940, and associated Rules.
Drug regulators are also expected to intensify inspections to ensure that pharmacies do not continue dispensing the medicine without prescriptions.
Medical experts have increasingly voiced concern over the misuse of prescription medicines among adolescents and young adults, especially drugs that affect the nervous system and are easily accessible without strict checks.
In a letter published in November last year in The Lancet Regional Health – Southeast Asia, Dr. Surender Grover, Dr. Jadeer K. Muhammed, Dr. Atul Ambekar and Dr. Priyanka Saha from the National Drug Dependence Treatment Centre, AIIMS Delhi, had raised concerns over the rising misuse of Pregabalin, warning that the widely prescribed drug was increasingly finding its way into black markets and recreational substance abuse networks across India.
The medical experts had pointed out that Pregabalin is sometimes consumed alongside opioids, alcohol or sedatives to intensify intoxicating effects, increasing risks of overdose, impaired judgement and dependence.
The Union Health Ministry’s recent decision to move Pregabalin under Schedule H1 is now being viewed as an attempt to strengthen monitoring without immediately invoking the harsher provisions of the NDPS Act.
Public health experts say the move reflects growing concern over the misuse of prescription medicines among youth and the expanding market for pharmaceutical drug abuse in India.
Doctors warn that prolonged misuse of Pregabalin can lead to dependence, impaired judgement, dizziness, confusion, drowsiness and psychological disturbances. In some cases, excessive consumption may also increase the risk of accidents and mental health complications.
Schedule H1 medicines are subject to stricter control than ordinary prescription drugs because of their higher abuse potential or public health implications. The category already includes several antibiotics, anti-tuberculosis medicines and habit-forming pharmaceutical products.
Doctors have meanwhile cautioned genuine patients against stopping Pregabalin abruptly without medical consultation. Sudden withdrawal may trigger anxiety, sleep disturbances, seizures and worsening pain symptoms in some individuals who are taking the medicine under supervision for chronic conditions.
Authorities have advised manufacturers, distributors, wholesalers, pharmacists and retailers to ensure immediate compliance with the new notification. The Ministry has indicated that stricter monitoring and enforcement action will continue in order to prevent diversion of the drug into illegal channels.
Way back in 2018, the WHO's Expert Committee on Drug Dependence (ECDD) had reviewed pregabalin in response to reports of its misuse around the world. The WHO ECDD reported limited data on the extent of problems related to pregabalin abuse in the general population and had further recommended that “pregabalin should not be scheduled but should be kept under surveillance.”
