Maha FDA detects cases of steroid-laden creams being sold as OTC drugs

Maharashtra Food and Drug Administration (FDA) has detected cases of leading brands in the country promoting skin creams as OTC drugs for treatment of skin ailments through self-medication in violation of labelling conditions of the Drugs and Cosmetic Rules, 1945. 

The state regulator is planning to take action against the companies as provisioned under Rule 106 to be read along with Schedule J and Section 18 (6). Stocks worth over Rs.70, 000 have already been seized from retailers in Mumbai alone.

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 contain steroids like fluocinolon acetonid and mometasone along with skin bleaching agents.

According to a senior FDA official, these skin creams violate the labeling conditions of the Drug Rules and make false claims of making a person fair despite the fact that they are mild steroids. They are recommended to be taken under the direction/ supervision of a senior skin care specialist or dermatologist. Sold under brand names like SuperGlow, My Fair, Skinbrite and ClearSkin, they have Hydroquinone, Tretinoin, Mometasone Furoate which are meant to treat skin disorders based on a doctor’s supervision. 

According to FDA, 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 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.

Maharashtra FDA had also detected cases of illegal sale of steroid-laden creams in the past and cancelled license of a Mumbai based retailer. FDA is also planning to prosecute 3 people involved in illegal sale of Betnovate C cream and Betnovate cream N without a bill worth Rs.40 lakhs in contravention to the provisions of Drugs and Cosmetics Act, 1940.

An FIR has also been filed against the retailer and persons involved in the racket who used to sell these creams with false and misleading claims of enhancing skin complexion despite the fact that it contains a potentially dangerous steroid Betamethasone Valerate which can cause skin cancer.

According to FDA’s recent order, these creams should only be sold only under the prescription of a physician. Meanwhile, government has also considered the proposal to amend a rule that currently exempts steroid based skin creams from being labelled as Schedule H drugs during a recent meet of the Drugs Technical Advisory Board (DTAB) held in Delhi.

The recommendation for such an exemption was in view of the proposal made by the Indian Association of Dermatologists, Venereologists and Leprologists (IADVL).

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. Other steroids like fluocinolone, hydroquinone and tretinoin are often prescribed for skin diseases like melasma or discoloration but long term usage can cause severe side effects.

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=96432&sid=1