Maharashtra FDA cracks down on ‘steroid-laden’ fairness creams

In order to curb the malpractice of selling prescription drugs in the name of cosmetics, the Maharashtra Food and Drug Administration (FDA) has directed Himachal Pradesh based manufacturer Torque Pharma to withdraw two of its products from the market - UB Fair for men and No Scars cream for women.

The FDA has seized its products from different locations in the state. The action comes in response to a letter by the Indian Association of Dermatologists, Venereologists and Leprologists, a national body of skin specialists, to the FDA demanding that the administration keep a watch on irrational sale of steroid based skin creams.

The Maharashtra FDA has also asked the Himachal Pradesh drug controller to take action against the company under the provisions of Drugs and Cosmetics Act.

Maharashtra FDA's action against two Torque Pharma products, is based on the ground that the products have been advertised as beauty treatments in contravention to the provisions of Schedule J of Drugs and Cosmetics Act, 1940 and Drugs and Magic Remedies Act.

Maharsashtra FDA joint commissioner Omprakash Sadhwani said, ''Steroid-laden drugs were being sold by Torque Pharma as over-the-counter cosmetics. The drugs positioned as fairness creams through 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.''

The two products 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.