The Medical Devices ( Draft Amendment) Rules, 2022.

The Registration Certificate issued in Form MD-42, shall remain valid in perpetuity, subject to payment of Registration Certificate retention fee as specified in the Second Schedule before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by State Licensing Authority.

Relaxation in Drugs Rules and New Drugs and Clinical Trials Rules for making available suitable drugs to meet the requirements arising due to COVID-19

The Central License Approving Authority or the State Licensing Authority, as the case may be, if satisfied that requirements under the provisions of the said Act and the Drugs Rules, 1945 and the New Drugs and Clinical Trials Rules, 2019 have been complied with, grant License to manufacture and stock the new drug subject to the condition that the licensee shall sell or distribute the new drug only after obtaining permission for such new drug in Form CT-23.

The Drugs (Draft Amendment) Rules, 2022.

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.