The Maharashtra Food and Drug Administration (FDA) is all set to launch prosecution against manufacturers of steroid-laden skin creams for violating the labeling conditions of the Drug Rules and making false claims of making a person fair.
These creams which contain mild steroids and are recommended to be taken under the supervision of a skin care specialist or dermatologist were being advertised and sold in the brand names - My Fair, ClearSkin, SuperGlow and Skinbrite.
These creams which were being sold as OTC drugs have ingredients like hydroquinone, tretinoin, mometasone furoate which are meant to treat skin disorders based on a doctor’s supervision. Mometasone is a potent steroid that can cause acneiform eruption on the face, unwanted hair growth, rosacea (pustular lesions), perioral dermatitis (facial rash) and fixed redness.
According to officials, drugs positioned as fairness creams through companies' advertisements have misled the public with false claims on enhancing skin complexion and treatment, a practice that is prohibited, and the use of which could aggravate skin problems.
The Union health ministry has also considered the proposal to amend a rule that currently exempts steroid based skin creams from being labeled as Schedule H drugs during a recent meeting of the Drugs Technical Advisory Board (DTAB) held in Delhi.
FDA had earlier detected cases of leading cosmetic brands also in the country promoting skin creams as OTC drugs for treatment of skin ailments through self-medication in violation of labeling conditions of the Drugs and Cosmetic Rules, 1945.
Action will be taken against the companies as provisioned under Rule 106 to be read along with Schedule J and Section 18 (6).
State regulator had earlier seized such steroid-laden creams from different locations in the state and detected two such cases in the past of products UB Fair for men and No Scars cream for women containing steroids like fluocinolon acetonid and mometasone along with skin bleaching agents.
The products are supposed to be advertised or positioned as a drug which requires a prescription for its use as indicated clinically and not to be sold or to be used as a cosmetic under the provisions of the law.