Govt to include psoriasis drug acitretin in Schedule H

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Govt of India

The Union health ministry will soon include psoriasis drug “Acitretin” in the Schedule H of the Drugs Rules, 1945 to prevent adverse events during pregnancy.

The ministry’s action in this regard is based on the Drugs Technical Advisory Board (DTAB)’s recommendations.

CDSCO FDA

Acitretin is one of the systemic retinoids used in medicine particularly in dermatological diseases and has a serious side effect profile particularly pregnancy related (teratogenic drug). A teratogen is an agent that can disturb the development of the embryo or fetus. Teratogens halt the pregnancy or produce a congenital malformation (a birth defect). Classes of teratogens include radiation, maternal infections, chemicals and drugs.

A retinoid has a structure similar to vitamin A and is involved in the normal growth of skin cells. Acitretin works by inhibiting the excessive cell growth and keratinisation (process by which skin cells become thickened due to the deposition of a protein within them) seen in psoriasis. It therefore reduces the thickening of the skin, plaque formation and scaling.

A representation was made to the DTAB on February 06, 2021 wherein it had been requested for inclusion of the drug ‘Acitretin’ in the Schedule H of Drugs and Cosmetics (D&C) Rules 1945.

In the representation made to DTAB, it has been stated that the drug acitretin is not included in any Schedule of the D&C Rules 1945, which requires prescription from the RMP. ‘Acitretin’ possesses the status of non-prescription and over the counter drugs (OTC) in India.

Central Drugs Standard Control Organisation (CDSCO) had approved acitretin for severe psoriasis in adults (excluding female of child bearing potentials) on September 09, 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 following warning; “Acitretin should be prescribed by dermatologists knowledgeable in systemic use of retinoid.”


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