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Health ministry proposes inclusion of analgesic drug pregabalin under Schedule H1
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Our Bureau, New Delhi
January 31 , 2026
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The Union ministry of health and family welfare has issued a draft notification to amend the Drugs Rules, 1945 to include analgesic drug Pregabalin and its drug formulations under the Schedule H1 of the Rules, in light of its misuse and intoxication.
The proposed amendment is expected to add the drug as serial number 51 of the Schedule H1, to monitor the sale of drugs only on the prescription of the Registered Medical Practitioner (RMP).
The draft amendment will be taken into consideration on or after expiry of 30 days from its publication in Gazette of India and once finalised the rule shall come into force after three months of publication of the final rules in the Official Gazette.
Under the Rules, the supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.
The move follows the recommendation of the Drugs Technical Advisory Board in its 65th meeting held on December 20, 2024. The Drugs Consultative Committee (DCC) has earlier considered the issue of potential misuse of the drug, along with opioid pain-relief medicine tapentadol and appointed a sub-committee to look into the issue.
During the period from January to December, 2024, the Food & Drugs Administration (Drugs Wing), Government of Punjab, seized drug formulations containing Pregabalin from 72 premises on firms, amounting to Rs. 5.97 crore. Additionally, the licenses of 12 firms were cancelled, licenses of 46 firms had been suspended and 11 complaints have been filed in the courts.
The drug regulatory authority from Punjab informed the DCC that the drugs formulations containing Pregabalin 150mg/300mg are being misused for intoxication, and requested that the Pregabalin and its preparations may be included in Schedule H1 of the Drugs Rules 1945.
Further, as the said drugs do not have much therapeutic usage and are being misused for intoxication, continuation of DCGI approvals of the dosage forms containing Pregabalin 150 mg and 300 mg may be re-evaluated, it added.
So far, the drug formulations containing Pregabalin are neither Schedule H nor in Schedule H1 of the Drugs Rules, 1945.
The drug formulations containing Pregabalin are available in different strengths in the market containing Pregabalin from 75mg to 300mg per unit dosage form.
The drug formulations containing Pregabalin are generally prescribed by the doctors for the management of neuropathic pain, to treat fibromyalgia. Pregabalin capsules/tablets are used along with other medications to treat certain types of seizures in adults and children of one month of age and older.
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