Denying Abbott proposal DTAB rules Zolpidem continues to be Schedule H1 drug

Zolpidem is a sedative hypnotic used for the short-term treatment of insomnia to improve sleep latency. Zolpidem belongs to a group of medicines called non-benzodiazepine hypnotics. It has hypnotic, sedative, and anticonvulsant (manages fits) properties. It works by binding of the GABAA receptor chloride channel macromolecular complex (a chemical messenger) that slows the activity of the nerve cells in the brain and helps fall asleep.

Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945 introduced in 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. The manufacture and sales of all drugs are covered under the Drugs and Cosmetics Act and Rules.

The drug label for Schedule H must exhibit the text "Rx" and Schedule H drug warning:

"To be sold by retails on the prescription of a Registered Medical Practioner only."

However, a new Schedule H1 was introduced through Gazette notification GSR 588 (E) dated 30-08-2013, which contained certain 3rd and 4th generation antibiotics, certain habit forming drugs and anti-TB drugs. These drugs required to be sold in the country with the following conditions:

(1) 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.

(2) The drug specified in Schedule H1 shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labelled with the following words in a box with a red border :

"Schedule H1 Drug-Warning:

-It is dangerous to take this preparation except in accordance with the medical advice.

-Not to be sold by retail without the prescription of a Registered Medical Practitioner."

Drugs that were previously classified as schedule H, such as antibiotics, anti-TB medicines, and habit-forming medications, were shifted to a new subcategory known as schedule H1.

At the 88th DTAB committee meeting, DTAB was apprised that the representation was received from M/s. Abbott India Ltd and FICCI wherein it has been requested to change schedule of Zolpidem Tartrate from Schedule H1 to Schedule H of the Drugs Rules, 1945.

The proposal was deliberated in the SEC (Neurology & Psychiatry) meeting held on 18.12.2019, wherein the committee deliberated the proposal in detail and recommended that the drug should continue to be Schedule H1 as it has potential for dependence.

The Board after detailed deliberation agreed to the recommendations made by the Subject Expert Committee and recommended,

"Zolpidem preparation shall continue to be in Schedule H1 of the Drugs Rules, 1945."