By Prescription only: Psoriasis drug Acitretin to be included Schedule H of Drugs Rules 1945
Acitretin to be sold only on prescription of Registered Medical Practitioner: MOHFW
New Delhi: Due to the highly teratogenic impact of the psoriasis medicine Acitretin, the Ministry of Health and Family Welfare has placed it on schedule H of the Drugs and Cosmetics Rules, 1945, limiting it to be marketed only on the prescription of a Registered Medical Practitioner. The said policy will take effect from November 2022.
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.
Confirmation to this effect was made by the recent gazette notification issued by Department of Health and Family Welfare, Ministry of Health and Family Welfare, Government of India which moved to amend the Drugs Rules, 1945 to include psoriasis drug Acitretin in schedule H of Drugs Rules 1945.
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, Medical Dialogues Team had reported earlier 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, considering the serious teratogenicity effect of Acitretin, 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 Central Government analyzed the objections and suggestions received from the public on the said draft rules published vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 75(E), dated the 1st February, 2022.
Following extensive deliberation, the Central Government issued a gazette notification stating,
" In exercise of the powers conferred by sections 12 and 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. (1) These rules may be called the Drugs (Fourth Amendment) Rules, 2022.(2) They shall come into force with effect from the 1st day of November, 2022.2. In the Drugs Rules, 1945, in Schedule H, after serial number 551 and the entries relating thereto, the following serial number and entry shall be inserted, namely:—"552. Acitretin".
