India’s obsession with fair skins is likely to face a regulatory crackdown with the government planning to ban over-the-counter sales of steroid-laced fairness cream without prescriptions. The ministry of health and family welfare is all set to regulate over-the-counter sale of fairness creams carrying corticosteroids — a steroid hormone known to cause severe skin damage and other health hazards. Some fairness cream makers add corticosteroids thanks to their effectiveness in lightening skin colour. Dermatologists say it is impossible to find out how many brands use these steroids as manufacturers do not mention them on their packs, in breach of labelling rules. Ironically, topical creams also do not come under the purview of schedule H, which means that they can be purchased over the counter and used without a doctor’s prescription. A notification to this effect is likely to come soon. The government has proposed amendments to the Drugs and Cosmetic Rules, 1945 inserting potent corticosteroid ingredients in Schedule H, which would restrict the over-the-counter sale of these topical creams. According to the draft notification, these will affect creams using the following so-called “potent topical steroids”:
- Diflorasone Diacetate
- Halobetasol Propoionate
- Prednicarbate and
- Triamcinolone Acetonide.
The Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) suggested making amendment in the D&C rules raising their concerns with the health ministry and the Central Drugs Standard Control Organization (CDSCO). The manufacture and sale of all drugs are covered under the Drugs and Cosmetics Act and Rules. Dermatologists found a link between using these creams and cases of Topical Steroid Damaged Face (TSDF)’ s type of skin damage due to steroid-laced creams as well. Dermatologists say that simple skin ailments are now becoming almost non-treatable due to the widespread use of creams that contain a cocktail of steroids. There’s also an increase in the number of patients who are showing the side-effects of steroid use. The matter was taken up by the drug technical body — Drugs Technical Advisory Board which recommended inserting steroid-laced fairness cream in schedule H.