Hindustan Unilever and Emami to weaken

Hindustan Unilever (HUVR IN) and Emami (HMN IN) - stocks are weak possibly due to one fairness cream being pulled off the market by the FDA; possible action to be taken on other brands...

News article from Mumbai Mirror

Crackdown on steroid-based beauty treatments - FDA pulls fairness cream off market, more brands may face similar action

Notices issued to company that promises its products will result in fair complexion; skin specialists warn of unwanted hair, acne, rash and dire side effects from prolonged use

The Food and Drug Administration has issued notices to Himachal Pradesh based beauty products manu facturer Torque Pharma and seized two of the company's skin creams from various locations in the state. The FDA's action is directed at steroid-laden drugs sold by Torque Pharma as over-the-counter cosmetics, a practice that is prohibited, and the use of which could aggravate skin problems. According to a FDA official, the drive could signal the launch of similar measures against other pharma companies dealing in such products.

The drive against two Torque Pharma products, UB Fair for men and No Scars cream for women, which are advertised as beauty treatments, was conducted 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 known to cause side effects like skin thinning, rashes, excess facial hair growth if used for a long time“.

“The advertisements promised a fair and beautiful complexion. These steroid containing creams are to be sold as drugs with proper prescriptions and not as over-the-counter cosmetics,“ said FDA commissioner Harshadeep Kamble.

The two products contain steroids like fluocinolon acetonid and mometasone along with skin bleaching agents. “We have seized the stock and further seizures will follow. The inspectors are on the lookout for other such products,“ said Kamble.

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.

Skin specialists say the seizure is indicative of a more pervasive malaise. “We are getting increased number of patients who have worsened skin problems due to use of steroid based creams. It is worrisome to know that in almost all these cases, the cream is bought over the counter with consultation from a chemist or the name of the cream is passed on by a friend or a relative. A doctor is never in the picture,“ said skin specialist Dr Kiran Nabar, managing committee member of IADVL Maharashtra.

According to Goregaon based dermatologist and cosmetologist Dr Vibhavari Nigale, topical steroid abuse has assumed the manner of an epidemic. “Everyone here wants to be fair and have a glow. And thus there is tremendous abuse of these creams that are now also being given by beauticians in parlours,“ said Nigale adding that some steroidbased creams are not categorised as Schedule H, and can be purchased over the counter.

Nigale cited the examples of three patients she treated on Monday who used steroidbased creams regularly. “While two of them wanted a fair complexion and were prescribed the cream by a beautician, the third woman was using the cream prescribed by a relative to get rid of her pigmentation,“ said Nigale adding that all of them had drastic side effects as they were using the creams for over six months.

Experts say that topical steroids have a wide range of potency. 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.

The IADVL has launched a nationwide campaign to combat indiscriminate use of topical steroids. The IADVL Task force Against Topical Steroid Abuse (ITASTA) has been constituted. “We will soon meet state health minister Deepak Sawant to take our cause forward,“ said Nabar adding that ITASTA has communicated to major pharmaceutical companies and requested them to stop the manufacture and marketing of irrational steroidbased combination creams. “We have also asked them to refrain from marketing steroidbased creams to AYUSH [Ayurveda, Yoga, Unani, Siddha and Homeopathy] practitioners and quacks. Posters and pamphlets are also being prepared for distribution to chemists,“ he said.

When reached for comment, Sajan Sahani, who tends to regulatory affairs at Torque Pharma said, “Yes, we have received the notices from the FDA.“ He refused to elaborate.