Creams with steroids pushed via loophole

With more than thousand steroid-containing skin creams being sold in the market without any check, skin specialists have approached the authorities to remove an old footnote in the Drugs and Cosmetics Rules, 1945, which is being misused by the manufacturers to sell these ointments without regulatory screening.

These creams containing steroids and other medicines are sold as over-the-counter drugs as the footnote made an exception for steroids that are used in topical (skin) preparations and eye ointments. Oral forms of these drugs do not exist.

Topical steroids used for periods as short as 15 days can cause substantial and often permanent damage, especially on thin skin such as on the face and groin. Children are more susceptible.

“These ointments are sold as OTC drug, for all practical purposes that needs urgent revision. Even some of the fairness creams contain steroids,” said Shyam Verma, an experienced dermatologist from Vadodara and a member of Indian Association of Dermatologists, Venereologists and Leprologists (IADVL), which red-flagged the problem.
Last week, a IADVL delegation met the Drugs Controller General of India G N Singh to apprise him of the extent of the potential risk.

“The DCGI agreed to examine the issue by the Drugs Technical Advisory Board (DTAB). We have also written to the DTAB with a request for amending the rules,” Abir Saraswat, a Lucknow-based doctor, who is the convener of the IADVL task force against topical steroid abuse told Deccan Herald. The DCGI and DTAB come under the Health Ministry.
Indian data on the misuse of topical corticosteroids is sparse, but industry figures suggest that production, sale and prescription of these creams have grown in the past three years.

In 2014-15, the market in India was worth more than Rs 1,500 crore, 11 per cent higher than the previous year. There are about 1,050 brands of topical steroids sold in the Indian market.

While dermatologists are all too familiar with the side effects of topical corticosteroid misuse, epidemiological evidence is lacking. A 2013 study on 433 users of topical corticosteroids indicated that more than 90 per cent of the people faced adverse effects.
“When it comes to skin ointment, everything comes to a naught. The misuse can also add to drug resistance as many of them also contain antibiotic and anti-fungal medicines,” Saraswat said.

Many pharmacists sell these creams without a prescription, ignoring the box warnings and patients often repurchase drugs and share them with friends and relatives with similar symptoms to save the cost and inconvenience of a dermatological consultation.

The popular myth that no externally applied drug can be dangerous feeds such use.
“Most developed countries restrict the sale of topical corticosteroids by making prescription compulsory, because they should be used judiciously,” Verma added.