Corticosteroids can be sold in India only on production of a registered medical practitioner’s prescription as they are included in schedule H of the Drugs and Cosmetics Rules 1945. However, a footnote in the Rules exempts eye ointments and topical preparations like skin ointments, creams and lotions from the list.
Thus, topical preparations containing steroids, including strong corticosteroids, prescribed by dermatologists and others can essentially be sold as “over-the-counter” (OTC) drugs.
“Even ofloxacin, which is a schedule H1 drug, is freely used in topical preparations,” said Dr. Abir Saraswat, dermatologist based in Lucknow and a member of the Indian Association of Dermatologists, Venereologists and Leprologists.
The schedule H1 category was introduced with an express intent of preventing any misuse of 46 third and fourth generation drugs and delaying drug resistance from emerging. Since March 1, 2014, the schedule H1 drugs could be sold by chemists only on production of a valid prescription. The chemist has to maintain a separate register that has details of patients and prescribing doctors. The register has to be retained for at least three years.
Worse, steroid cocktails, which are in fixed dose combinations, are mixed with various antifungal and anti-bacterials, thus making the drugs extremely dangerous and irrational. Use of irrational topical steroid combinations can lead to drug resistance.
“Dermatologists are seeing increasingly widespread fungal diseases where the use of irrational combination drugs has been implicated. The fungal diseases do not respond to conventional drugs for conventional duration and dose,” said Dr. Shyam B Verma, dermatologist based in Vadodara, Gujarat.
“Indian doctors are witnessing a pandemic of adverse effects induced by topical corticosteroids,” Dr. Verma writes in a news piece published a few days ago in The BMJ .
Topical steroids can cause substantial and permanent damage, especially to thin skin such as on the face and groin, even if used for a short period of 15 days. Side effects include pigmentation and atrophy of the skin. “Misuse of steroid combinations can cause bacterial or fungal resistance, which can make infections difficult to diagnose and treat,” Dr. Verma writes.
According to a 2011 study, nearly 15 per cent of dermatological patients were found using topical corticosteroids. Of the 15 per cent, over 90 per cent had adverse effects.