Four CNS drugs to come under Schedule H1 controls amid abuse concerns

Four widely used Central Nervous System medications, including Zopiclone and Gabapentin, have been placed under Schedule H1 controls amid concerns over over-the-counter availability and off-label intoxication. Chemists will have to follow stricter prescription, record-keeping and warning-label requirements for these drugs.

Hyderabad: Amid concerns over casual over-the-counter availability and growing patterns of off-label intoxication for recreational purposes, the Central Drugs Standard Control Organization (CDSCO) has placed four widely used Central Nervous System (CNS) medications under the stringent controls of Schedule H1.

The CDSCO, through a notification, has also decided to track physical prescription requirements and special warning labels for the four drugs – Zopiclone, Gabapentin, Flupentixol, and Carisoprodol.

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The move follows concerns flagged by the Drugs Consultative Committee over the abuse of these drugs and concerns over their over-the-counter availability and growing patterns of off-label intoxication, which means they were being used by substance addicts to get intoxicated.

From now on, these drugs will be strictly based on medical prescriptions and chemists must maintain audit registers of the sale of such drugs and record patients’ names, addresses and details of doctors who have prescribed them.

Zopiclone is a hypnotic and widely prescribed for short-term insomnia management, while Gabapentin is used for neuropathic pain and seizure control. Flupentixol is an antipsychotic used for anxiety and depressive symptoms, while Carisoprodol is a muscle relaxant known to metabolise in ways that trigger high psychological dependence and euphoria-seeking misuse.

The mandatory warning labels will have to include special packaging, featuring a prominent red-bordered warning box alongside the symbolic red “Rx” sign, alerting buyers against self-medication.