By Doctors' Prescription only: Oseltamivir and Zanamivir added into Schedule H1 Drugs
New Delhi: Through a recent gazette notification, the Ministry of Health and Family Welfare, Government of India, has placed Oseltamivir and Zanamivir to Schedule H1 of the Drug Rules, 1945, restricting the sale of these two antiviral drugs on a prescription from a Registered Medical Practitioner.
This move came in line with the draft notification published by the Ministry on September 25, 2023, suggesting the insertion of Oseltamivir (serial number 49) and Zanamivir (serial number 50) into the list of medications listed as Schedule H1.
In view of the above, the draft notification invited objections and suggestions from stakeholders within thirty days.
Following this, the Central Government came up with the amendment to add Oseltamivir (serial number 49) and Zanamivir (serial number 50) to the list of drugs referred to as Schedule H1 after receiving and taking into consideration the public suggestions and consulting with the Drugs Technical Advisory Board.
The Drugs and Cosmetic Rules of 1945 allocated provisions for the classification of the drugs under various given schedules including details regarding the storage, display, sale, and prescription of an individual schedule. The prominent schedules included Schedule G, H, X, and J.
Schedule H1 has been introduced through Gazette notification GSR 588 (E) dated 30-08-2013 to check the indiscriminate use of antibiotics, anti-TB, and some other drugs in the country. The schedule contains certain 3rd and 4th generation antibiotics, certain habit-forming drugs, and anti-TB drugs.
Schedule H contains a list of drugs that can be sold only against the prescription of a registered medical practitioner. Another provision that needs to be followed is that only the required amount of medications mentioned in the prescription can be dispensed. These drugs can be supplied only to licensed parties.
The drug label must exhibit the text “Rx” and Schedule H drug warning: To be sold by retailers on the prescription of a Registered Medical Practioner only. As per the notification on 16th March 2006 released by the Department of Health under the Ministry of Health and Family Welfare, there are 536 Schedule H drugs. The original list contained 510 drugs but this has been revised by the Drugs Technical Advisory Board (DTAB) and the present list includes about 536 drugs.
The drug supplied under the schedule H1 specification should be recorded in a separate register at the time of supply, mentioning the name and address of the prescriber, the name of the patient, and the name of the drug along with the quantity supplied. This register has to be maintained confidentially for up to three years and should be open for inspection.
The schedule H1 drugs should be labeled with the symbol Rx in red, clearly displayed on the left top corner of the drug label. The label should also bear 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.”
In exercise of the powers conferred by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:
(1) These rules may be called the Drugs (Amendment) Rules, 2024.(2) They shall come into force on the date of their final publication in the Official Gazette.In the Drugs Rules, 1945, in Schedule H1, after serial number 48 and entries relating thereto, the following serial number and entry shall be inserted, namely:-“49. Oseltamivir 50. Zanamivir”.
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