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No topical steroid creams without prescription, says Centre

Topical steroid creams. Copyright: <a href=''>agephotography / 123RF Stock Photo</a>Topical steroid creams can no longer be sold over the counter in India. This is per a notification issued by the Ministry of Health and Family Welfare (MoHFW), banning the sale of fourteen topical steroid creams and ointments without prescription.

The ban comes after dermatologists raised concerns that overuse of such creams is leading to an uptick in ‘highly contagious’ fungal infections. However, ‘abuse of steroid creams and steroid combination creams is unchecked because the Health Ministry is not taking timely or adequate steps,’ said the Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) in a statement on World Skin Day.

“Misuse of topical steroid creams has caused ‘serious adverse effects on the health of millions of Indians'”

Topical steroid creams, or topical corticosteroids, are frequently prescribed products in India for a number of dermatological disorders. A 2016 study said they account for almost 82 percent of dermatological product sales in the country.,

Chemists often recommend such products to customers who proceed to use them without proper medical guidance, the study said. This provides the impetus behind making such products prescription-only.

Members of the IADVL Taskforce Against Topical Steroid Abuse (ITATSA) reportedly brought these concerns to the attention of the Drug Controller General of India (DCGI) on a number of occasions. Dissatisfied with the DCGI’s response (or lack thereof), ITATSA filed a public interest litigation (PIL) in the Delhi High Court (DHC).

The PIL said misuse of topical steroid creams ‘has caused serious adverse effects on the health of millions of Indians.’ It called for topical steroid creams to be recategorised as Schedule H products under the Drugs and Cosmetics Rules. These are products which are available only on prescription.

The DHC sided with ITATSA. It sent a notice to the Centre and the Central Drugs Standards Control Organisation (CDSCO), asking them to respond to the PIL.

The Drugs Technical Advisory Board (DTAB) took notice of dermatologists’ concerns. They recommended to the CDSCO and the MoHFW that topical steroid creams be  recategorised under schedule H.

The MoHFW acquiesced. They rescheduled fourteen topical steroid products including alclometasone, beclomethasone, and desonide. However, other schedule H products are widely sold without prescriptions. The law, which dates back to 1942, is often thought to be unclear about the kinds of medical practitioners who may issue these prescriptions.

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