Last Updated on January 6, 2024 by The Health Master
Download notification No. GSR 75(E) dt 01-02-2022: The ministry of health and family welfare (MoHFW) has issued a draft amendment notification to include psoriasis drug Acitretin in the Schedule H of the Drugs Rules, 1945 vide notification GSR 75(E) dt 01-02-2022.
Acitretin is one of the systemic retinoids used in medicine, particularly in dermatological diseases, and has a serious side effect profile, particularly related to pregnancy, as it is a teratogenic drug which can disturb the development of the embryo or fetus.
The draft rule follows a recommendation by the Drugs Technical Advisory Board (DTAB), in its meeting held on April 13, 2021.
It was informed that the drug is not included in any schedule of the Drugs and Cosmetics Rules, 1945, which requires a prescription from a registered medical practitioner.
Hence, the drug Acitretin has been under the status of non-prescription and over the counter drugs (OTC) in India. The DTAB was apprised of this situation through a representation it received in February, 2021, which requested for inclusion of the drug in the Schedule H of the Rules.
The Central Drugs Standard Control Organization (CDSCO) had approved Acitretin for severe psoriasis in adults (excluding female of child bearing potentials) on September 9, 2005, with the condition that the label of the immediate container of the drug as well as the packing in which the container is enclosed should contain the warning that it should be prescribed by dermatologists knowledgeable in systemic use of retinoid.
After deliberation, the DTAB meeting in April, 2021, agreed to include the drug in the Schedule H of the Drugs Rules, 1945.
The draft rule published by the Ministry on February 1, inserts Acitretin as serial number 552 in Schedule H, following the DTAB’s recommendation.
The draft rules shall be taken into consideration on or after the expiry of a period of 30 days from the date on which the copies of the Gazette of India containing the draft rules are made available to the public.
Objections and suggestions received within the period will be considered by the Central Government, said the notification.
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