The Union health ministry has brought the anticonvulsant and nerve pain drug, Pregabalin, under the stricter Schedule H1 category of the Drugs Rules, 1945, to curb its growing recreational abuse, according to a government official and a notification reviewed by Mint.
The 20 May gazette notification states that the stricter compliance rules will come into effect nationwide in 180 days.
The drug will now be sold only against a valid, stamped prescription from a registered medical practitioner, while pharmacists must maintain a separate register recording the patient’s name and address, the prescribing doctor’s details, and the quantity dispensed. These records must be preserved for at least three years and will be subject to surprise inspections by drug control officers.
In addition, product packaging must prominently display a red ‘Rx’ symbol and a Schedule H1 drug warning label highlighting the drug’s potential risks.
Violations and non-compliance will attract penal action under the Drugs and Cosmetics Act, 1940 and Rules thereunder, the health ministry said in a statement on Friday.
“With the 180-day transition timeline ticking in India, all manufacturers, wholesale distributors, and retail chemists must immediately re-align their operations to meet these rigorous tracking standards,” said the official on the condition of anonymity.
Leading domestic drugmakers such as Sun Pharmaceutical Industries Ltd, Torrent Pharmaceuticals Ltd and Intas Pharmaceuticals Ltd are among the key manufacturers of generic Pregabalin in India.
Mint's queries emailed to the health ministry, Sun Pharma, Torrent, Cipla and Intas remained unanswered.
Rampant abuse
The state regulators in Punjab, Haryana, and Delhi, during enforcement crackdowns over the past two years, detected extensive black marketing, unauthorized over-the-counter sales, and severe addiction trends, resulting in massive seizures of high-dose 150mg and 300mg formulations from unlicensed premises and retail chemists.
Though Pregabalin, a gamma-aminobutyric acid (GABA) analogue that suppresses excitatory neurotransmitters, is widely prescribed to treat diabetic peripheral neuropathy, fibromyalgia, postherpetic neuralgia and certain epileptic seizure disorders, users have increasingly sought it for its sedative, euphoric and dissociative effects, the person said, citing state controllers' inputs to the Central Drugs Standard Control Organisation (CDSCO).
In 2024, the Drugs Controller General of India (DCGI) constituted a sub-committee under the chairmanship of Atul Ambekar, a professor at the National Drug Dependence Treatment Centre (NDDTC), AIIMS, alongside senior experts and state drug control members. Concluding its evaluations, the committee formally recommended upgrading Pregabalin to Schedule H1 to curb drug abuse.
The Centre acted after recommendations from the Drugs Technical Advisory Board (DTAB), the top advisory panel to the Drugs Controller General of India (DCGI), as well as repeated warnings from state law enforcement agencies.
“Pregabalin is currently not scheduled at the international level or in India as a narcotic or psychotropic. Currently, it is not well recognized as a drug which can be misused. However, some instances of misuse as an addictive drug have come to light. Considering this, the step by the government to increase the regulation (H1, prescription only) is welcome," Abmekar told Mint.
"As and when more evidence about its addictive properties is available, its notification as a psychotropic substance should also be considered,” he added.
Global precedents
Globally, regulators have tightened controls on Pregabalin in response to its potential for abuse. In the UK, the drug was reclassified as a Class C, Schedule 3 controlled substance from a standard prescription medicine. Possession without a prescription is illegal; prescriptions are valid for only 28 days; and dispensing requires physical signatures rather than routine electronic processing.
In the US, Pregabalin is classified as a Schedule V controlled substance under the Controlled Substances Act, reflecting its accepted medical use alongside a recognized, though relatively low, risk of abuse and dependence. The classification subjects the drug to federal monitoring and refill restrictions.
Australia categorizes it as a Schedule 4 (S4) prescription-only medicine requiring close medical supervision, while the European Union broadly regulates it as a prescription-only medication.