Doc ire at fairness cream

Complaint to drug regulator on steroid-laced product

By G.S. Mudur
  • Published 12.06.15

New Delhi, June 11: An association of Indian dermatologists has opposed the launch of a new steroid-laced fairness cream at a time it has sought a regulatory crackdown and a ban on over-the-counter sales of similar products without prescriptions.

The association has complained to the national drug regulator and an advertising industry watchdog that the Chandigarh-based Torque Pharmaceuticals has launched a product called U-B Fair containing a corticosteroid as a non-prescription skin cream for fairness.

The cream, similar to others already in the market, is a well-known pharmaceutical formulation that combines three medications, including a steroid that dermatologists say should be sold only through prescriptions for specific skin disorders, and not for fairness.

"Given our cultural preference for fair skin, giving such products to consumers is like putting guns into the hands of children," said Shyam Verma, a dermatologist in Vadodara and coordinator of a campaign by the Indian Association of Dermatologists to curb over-the-counter sales of skin creams containing steroids.

The doctors say their campaign was inspired by anecdotal evidence of serious adverse effects from steroid-based face creams and a study across seven states that found six in ten people using such creams on the advice of friends, peers or relatives ---- not doctors.

In its complaints to the Drugs Controller General of India (DCGI) and the Advertising Standards Council of India (ASCI), the association has said that Torque is among several companies promoting the steroid-based formulation as a fairness cream for the general public.

A YouTube video features Bollywood actors Pulkit Samrat and Om Puri at what appears to be the launch of the product, whose package urges consumers to "apply (the cream) only once at night".

The company has said India's drug laws exempt external preparations such as U-B Fair from the need for prescriptions irrespective of their contents, and so they can be sold as over-the-counter medications without violating laws.

"Dermatologists have been grossly overcharging consumers for similar formulations," Sajan Sahni, manager (regulatory affairs) with Torque Pharmaceuticals, told The Telegraph.

"We provide consumers a product at a reasonable and affordable price, which is bound to pinch the concerned dermatologists."

The dermatologists' association says it has already asked the DCGI to work towards regulatory changes that would turn skin creams containing corticosteroids into prescription-only drugs.

"Unsupervised use of such creams can cause severe and potentially irreversible damage to skin," Anil Abraham, a dermatologist at the St John's Medical College, Bangalore, and dermatologist Abir Sarawat in Lucknow wrote in the complaint to the DCGI and the ASCI.

The DCGI had earlier this year written to state drug controllers conveying the concerns expressed by the dermatologists' association and asking them to "keep a vigil and take appropriate action" against erring firms. But doctors say little has changed on the ground.

"On the one hand, we've approached central and state drug regulators to raid outlets selling such products over the counter; on the other, we have a new product that has joined many already in the market," said Koushik Lahiri, a dermatologist in Calcutta and chairperson of the association's task force against the abuse of steroid-based skin creams.

A study by Saraswat and his collaborators from 10 cities across India had found that among 433 patients who had used steroid-based skin creams on the face, 257 (59.4 per cent) had been told to use the creams by non-physicians such as friends, peers or relatives.

The study, conducted nearly five years ago, also found that 126 (29 per cent) of the 433 patients had used the steroid-based face creams as a fairness cream, general face cream, or aftershave cream. None of these 126 had received a prescription from a doctor.

A Mumbai-based company that markets another steroid-based face cream said that its package inserts mention that the formulation should be used only under medical supervision.