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Stop indiscriminate OTC sale of topical steroid without prescription, most are Schedule H drugs
Drug company faces heat over fairness cream
Koushik Lahiri
Kolkata, WB, India
Sep 30, 2015 —
MUMBAI: A pharmaceutical company selling steroid-based fairness cream for men has landed in the Maharashtra Food and Drug Administration (FDA) net for running a mammoth advertising campaign about skin whitening. The drug regulator seized stocks worth over Rs 8 lakh from the company's warehouse in Bhiwandi and a distributor in Panvel over Friday and Saturday. Thousands of packs of 'U-B Fair' cream for men manufactured by the Torque Pharmaceuticals as an over-the-counter product, were seized by the FDA. Additionally, 'No-Scars' cream for women is also under the lens. The launch of U-B Fair cream containing corticosteroid in June was met with sharp criticism from dermatologists, who even approached the Drug Controller General of India asking for a ban on the product and the ones with similar composition. Experts claim the concoction of-corticosteroid, hydroquinone (bleaching agent) and tretinoin (vitamin A derivative) found in U-B Fair may not only have far-reaching skin complications but is also least preferred world over. A prohibition order has also been issued against the marketing of both the products in Maharashtra. "It is a drug and not a cosmetic product. It is not supposed to be sold without a prescription in supermarkets and chemist stores," said FDA commissioner Harshadeep Kamble. "The women's cream promoted as a face wash contains salicylic acid that can cause difficulty in breathing, dryness and even peeling of skin. Supervision while using them is imperative," he added. The marketing campaign that drew FDA's attention was unleashed through media and TV advertisements over the last few weeks. It promised fairer skin in a span of weeks. "Promising fairness is an outright violation of the Drug and Magic Remedies Act. Advertising about such cure or treatment too is not allowed under the Drugs and Cosmetics Act. It is punishable with up to 2 years' imprisonment," Kamble said. Torque Pharmaceutical could not be reached for comment on Sunday. However, the company's website confirms the products' composition. Dr K Narendra Kamath, one of the members of the Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) that has approached the health ministry for a ban, said the issue of steroid-based creams is a serious one. "As a country, we are obsessed with fairness. But, people do not realize that prolonged application of such creams can lead to premature ageing of skin, facial hair and steroid acne that does not get resolved in months. Most don't know that they should not step out in the sunlight after applying such creams as it can cause severe sunburn allergies," he added
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FDA PULLS FAIRNESS CREAM OFF MARKET, MORE BRANDS MAY FACE SIMILAR ACTION