The Ministry of Health and Family Welfare vide its notification dated 1st February 2022 has published the Drugs ( Draft Amendment) Rules, 2022 to further amend the Drugs Rules, 1945.
Through this amendment, the ministry has included drug “Acitretin” in the Schedule H of the Drugs Rules, 1945 to prevent adverse events during pregnancy.
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.
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.
The Ministry has invited Objections and suggestions from the public on the above draft which shall 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. within 30 days.
