The Drug Controller General of India (DCGI) has banned the over-the-counter (OTC) sale of 14 different types of steroid-based fairness creams in India. In a notification released by the Union health ministry, the Central government has amended the Drugs and Cosmetic Act 1945 to bring in the steroid-based creams under the list of Schedule H drugs and made it mandatory to have prescription to avail the same.
According to the notification, creams and ointments based on a total of 14 steroids, have been adjudged not to be sold without a prescription by the doctors. With this new amendment to the D&C Rules 1945, fairness creams that have steroids can no longer be sold over-the-counter by the chemists. The fairness creams which contain chemicals like alclometasone, beclomethasone, betamethasone, desonide, desoximetasone, dexamethasone, diflorasone diacetate, fluocinonide, fluocinolone acetonide, halobetasol propionate, halometasone, methylprednisone, prednicarbate and triamcinolone acetonide can now be bought only with a prescription by the physician.
Apart from these mentioned steroids, earlier other steroids that were available with the chemists as OTC drugs to treat skin infections like fungal infections and other skin problems have also been grouped under Scheduled H drugs list and they too are now can be bought only with doctor’s prescription. In all a total of 14 different steroids based facial and skin ointments have been brought under Schedule H drugs list.
However, as per the notification, it is stated that the normal face cleaners and moisturisers which do not have topical preparations can be sold by chemists as OTC creams.
Earlier, the Indian association of dermatologists, venereologists and leprologists had raised concerns over the misuse and abuse of steroids based creams, which were leading to resistance in the treatment of fungal infections. Taking cognisance of this, the drug control general of India has amended its D&C Act 1945 and had banned the OTC sales of the steroid laden fairness creams and ointments.
While commenting on the new amendments to the D&C Act 1945 to ban OTC sale of the steroid based creams, Dr. M. Somla Nayak, a dermatologists from SVS Medical College says, “It is a welcome move by the government. Because indiscriminate use of un-prescribed steroids will lead to resistance by fungus and other bacteria and it will cause more damage in the long run.”