Scanner on risky skin creams

G.S. Mudur, TT, New Delhi, Nov. 25:India's drug regulator has agreed to examine a footnote in its rulebook that allows pharmaceutical companies to sell potentially dangerous skin creams over the counter for infections, fairness and good-looking skin.

The Central Drugs Standards Control Organisation (CDSCO), alerted by dermatologists that India is witnessing a pandemic of side-effects of these creams, has asked an advisory board to find ways to revise the footnote to curb the sales of such products.

Many of these creams are irrational combinations of steroids and other drugs that conflict with each other, or contain unnecessary drugs that don't help patients while exposing them to their potential side-effects.

The steroid-based creams are at times needed to treat skin disorders such as eczema, an inflammatory condition, or psoriasis, an autoimmune disease.

Steroids work by decreasing inflammation and reducing the activity of the immune system.

But anecdotal accounts and studies from across the country suggest that many people are using steroid-based creams for conditions such as fungal infections, acne and non-specific itching - and to get a fairer skin.

Since their inhibition of immune responses increases the risk of infection, steroids are not usually preferred in the treatment of infections. And acne can itself be a side effect of steroid use.

The solution, dermatologists say, is for patients to use skin creams or ointments only after seeing a doctor, who clearly diagnoses the problem and prescribes only the specific drug needed.

The Indian Association of Dermatologists, in several representations to the CDSCO, has warned that unjustified and unrestricted sales of medicated skin creams is leading to a range of side-effects in many users, from rebound acne to serious facial damage.
"We've received scientific findings and market data from dermatologists. We believe there is a case for our technical advisory board to examine this issue," Gyanendra Nath Singh, the drug controller-general of India and head of the CDSCO, told The Telegraph.

Pharmaceutical sales figures suggest that millions of people across the country bought steroid-based skin creams worth Rs 1,500 crore during 2014-15.

Some 85 per cent of these would have been "steroid cocktails" - combinations of potent steroids and one or two antibiotics or anti-fungal drugs, said Shyam Verma, a Vadodara-based dermatologist who had analysed the 2014-15 sales using market figures.

Verma has calculated that the sales of irrational combinations grew 26 per cent during 2014-15 over the previous year, with a cocktail of the steroid clobetasol, an anti-protozoal called ornidazole, an antibiotic called ofloxacin and an anti-fungal called terbinafine recording the highest increase in sales.

"The sales of such products would be unthinkable in developed countries, but here they are prescribed by even medical practitioners or sold as over-the-counter products," said Verma, who flagged the subject in today's issue of the British Medical Journal.

Steroids are among drugs listed under Schedule H of India's drug rules, and are thus required to be sold only against prescriptions. However, a footnote in the rules appears to exempt steroid preparations from Schedule H if they are intended for use on the skin, eyes or ears.

"This ambiguity in the law allows unscrupulous companies to pass off such products as over-the-counter products," said Binod Khaitan, professor of dermatology at the All India Institute of Medical Sciences, New Delhi. "We have pointed this out to drug regulators."

A 10-city study by a group of dermatologists had four years ago screened 2,926 patients with skin disorders and found that among 433 patients who were using steroid skin creams, 392 (90.5 per cent) had experienced side effects of the creams.

Medical studies suggest that steroid-based creams, when used even for periods as short as two weeks, can lead to substantial damage, particularly on thin skin such as on the face and the groin.

"In our practice, we routinely see patients with facial skin damaged by steroid creams," said Abir Saraswat, a dermatologist from Lucknow who was among a group of representatives from the Indian Association of Dermatologists that met Singh at the CDSCO last week.

India's shortage of dermatologists may be exacerbating the problem. Verma says India has only 8,500 dermatologists, or about one for every 150,000 population.

The 10-city survey had found that nine in 10 patients who were using steroid skin creams either did not need them, or were using the wrong levels, or applied the cream without any diagnosis of their underlying skin condition.

"Many young men and women use them for fairness or to maintain healthy-looking skin without any underlying skin disorder," Saraswat said.

"Steroid creams can make skin appear lighter. The steroid makes the skin thinner and reduces the activity of the cells that produce melanin, the dark pigment."

He added: "But this comes at a huge cost. Long-term use of steroid-based creams can cause irreversible damage."