Against the backdrop of illegal sale of steroid-laden creams in the past, the Maharashtra Food and Drug Administration (FDA) has recently cancelled license of a Mumbai based retailer and initiated the process to prosecute 3 other 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 use 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 labeled 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).
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 to be used as a cosmetic under the provisions of the law of the land
State regulator had seized such steroid laden products 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.
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.
In 2011, a study published Indian Journal of Dermatology, Venereology and Leprology that was carried in 12 cities had revealed that 60 per cent of patients who had skin problems on their face were using self-prescribed steroid-based creams. The study named the condition as "topical steroid-dependent face" and recommended a more stringent implementation of existing laws to limit public access and advertising of potent topical corticosteroids.