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 21st January 2026, India’s Central Drugs Standard Control Organisation (CDSCO) amended the Drugs and Cosmetics Rules, 1945 to place all pregabalin formulations under Schedule H1.
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.
Previously, pregabalin was listed under Schedule H, which required only a prescription with no additional documentation or tracking requirements.
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. Such formulations were seized from licensed and unlicensed premises.
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, international regulators have responded by classifying pregabalin as a controlled substance to mitigate diversion and misuse concerns.
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
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