Pregabalin is an anticonvulsant and analgesic medication belonging to the gabapentinoid class. It is prescribed for conditions such as neuropathic pain, fibromyalgia, and as an adjunct therapy in some types of seizures, and is also used off-label in certain anxiety disorders. Its mechanism involves modulating neuronal excitability through binding to voltage-gated calcium channels.
On 21 January 2026, India’s Central Drugs Standard Control Organisation (CDSCO) issued a notification amending the Drugs and Cosmetics Rules, 1945 to place all pregabalin formulations under Schedule H1 of the Rules, a more stringent category requiring detailed prescription and record-keeping norms. This gazette notification formalises the move to tighten control over pregabalin sales amid rising concerns about its non-medical use.
Schedule H1 means:
Pregabalin can only be sold against a valid prescription from a registered medical practitioner.
Pharmacists and retailers must maintain detailed records of:
Prescribing doctor’s name and address
Patient identity details
Quantity and date of dispensed drug
These records must be retained for three years and available for inspection by authorities.
Prior to this amendment, pregabalin was not included under Schedule H1, and its sale was governed by standard Schedule H norms without stringent record-keeping.
State drug regulators, including officers in Punjab, reported that pregabalin tablets and capsules, especially at higher strengths like 150 mg and 300 mg, were being diverted for non-medical use and intoxication. Authorities have seized pregabalin from licensed and unlicensed premises amid concerns it was being sold and used illicitly.
Analyses in pharmacovigilance and clinical settings indicate:
Pregabalin has a potential for misuse, particularly when used in doses much higher than those prescribed clinically.
Recreational misuse can produce euphoria and dissociative effects, which may attract individuals with substance use history.
Higher doses significantly exceed usual clinical doses (e.g., up to 12,000 mg/day reported in case studies outside routine therapeutic ranges).
Common side effects include:
Dizziness, drowsiness, sleepiness
Headache and weight gain
Coordination and balance issues
Euphoria or “feeling high” at high doses
While pregabalin has generally lower abuse potential than many controlled substances, evidence from clinical and case reports indicates:
Misuse tends to occur in individuals with prior substance use disorders.
Higher than recommended doses can produce psychoactive effects sought for recreation.
Cases of tolerance and withdrawal symptoms have been described in clinical literature.
In some regions internationally, regulatory bodies have taken steps to monitor or control gabapentinoids more closely. For example, several European countries and parts of North America regularly evaluate gabapentinoid misuse patterns and issue guidance regarding tighter prescribing and surveillance.
Mandatory prescription verification and record keeping
Compliance with labeling and inspection norms
Potential penalties for non-compliance under drug regulation laws
Increased scrutiny on valid indications and dosing
Importance of documenting clinical justification
Awareness of misuse potential in patients with substance abuse history
Pregabalin will continue to be available only via prescription
Improved monitoring aims to maintain access for those with legitimate medical needs while reducing diversion
India, Ministry of Health and Family Welfare, Drugs and Cosmetics Rules, 1945, G.S.R. 54(E) Draft Notification for Amendment in Schedule H1 for Inclusion of Pregabalin and its drug formulations, January 21, 2026. Government Gazette Notifications, Central Drugs Standard Control Organization (CDSCO). https://www.cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/.
Gupta, Meghna, and Jawahar Singh, and Bharat Udey. “Very high dose of pregabalin abuse: A case report.” Indian Journal of Psychiatry 65, no. 9 (2023): 979-980. https://pmc.ncbi.nlm.nih.gov/articles/PMC10569330/.
Aneja, J., and J. Singh. “Pregabalin Use/Misuse: A Source of Consternation in Western Punjab.” Indian Journal of Psychological Medicine 45, no. 2 (2023): 206-207. https://pmc.ncbi.nlm.nih.gov/articles/PMC10011841/.
(Rh/TL/MSM)
