Last Updated on January 6, 2024 by The Health Master
Download GSR 357 (E) Dt 18-05-2022, link given below: The Union ministry of health and family welfare (MoHFW) has notified the addition of psoriasis drug acitretin under the Schedule H of the Drugs Rules, 1945 vide notification GSR 357 (E) Dt 18-05-2022.
Acitretin is one of the systemic retinoids used in medicine particularly in dermatological diseases.
It 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 amendment called the Drugs (Fourth Amendment) Rules, 2022, 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 prescription from the 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 Organisation (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 of the rule was published by the Ministry on February 2, 2022, inserting acitretin as serial number 552 in Schedule H, following the DTAB’s recommendation.
Objections and suggestions received from the public following the draft notification were considered by the Central government, said the final notification.
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