Govt to include psoriasis drug Acitretin in Schedule H of Drugs Rules 1945

In India, Schedule H refers to a group of prescription drugs that are listed as an appendix to the Drugs and Cosmetics Rules, 1945, which were introduced in 1945. There are medications that can only be purchased with a qualified doctor's prescription and can not be purchased over-the-counter.

 Acitretin is a retinoid similar to vitamin A that is prescribed for individuals with extreme psoriasis, a skin condition characterised by swollen, scaly, or thickened skin and irregular skin cell formation. 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.

Acitretin is marketed in India by Glenmark, Dr. Reddy, Cipla, Ranbaxy, and IPCA Laboratories under the brand names Aceret, Acetec, Zoratame, Acrotac, and Acitrin respectively. 

However, Acitretin is highly teratogenic and must not be used during pregnancy. Acitretin use during pregnancy is strongly restricted because it can harm the unborn child and cause congenital disabilities. During Acitretin therapy and for three years after quitting acitretin, strict birth control methods must be used. As a result, acitretin is rarely prescribed to women who are planning to start a family.

In this regard, it is worth noting that CDSCO had approved Acitretin for severe psoriasis in adults (excluding female of childbearing potentials) on 09.09.2005 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"

Last year, the Medical Dialogues Team had reported that after considering the serious teratogenicity effect of Acitretin, a systemic retinoid prescribed particularly in dermatological diseases, the Drugs Technical Advisory Board (DTAB) had recommended including Acitretin in Schedule H of the Drugs Rules, 1945 to prevent adverse events during pregnancy.

Now in continuation, the draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to public.

Furthermore, the draft rules stated, "Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government."

"Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in.," the notice added.

In view of the above, as per the proposed amendment;

"1. (1) These rules may be called the Drugs (…..Amendment) Rules, 2022.

     (2) These rules shall come into force on the date of their final publication in the Official Gazette.

2. In the Drugs Rules, 1945, in Schedule H, after serial number 551 and the entries relating thereto, thefollowing shall be inserted, namely:—

"552. Acitretin". "

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