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Topical corticosteroid misuse in India is harmful and out of control

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h6079 (Published 25 November 2015) Cite this as: BMJ 2015;351:h6079
  1. Shyam B Verma, consultant dermatologist, Nirvan Skin Clinic, Vadodara, Gujarat 390009, India
  1. skindiaverma{at}gmail.com

Public and professional ignorance, legal ambiguity, and government indifference lead to widespread misuse of steroid containing skin creams and lotions, often in irrational combinations, which comes with substantial risk of harm, writes Shyam B Verma

Indian doctors are witnessing a pandemic of adverse effects induced by topical corticosteroids. Data on clinical use and misuse of topical corticosteroids in India are sparse.1 But production, sales, and prescribing have grown in the past three years, data from IMS Health show.2

The top prescribers of topical steroids in India, after dermatologists, are general practitioners, gynaecologists, paediatricians, and consulting physicians.2 In 2014-15 the market in India was worth Rs15.55bn (£155m; €218m; $234m), 11% higher than the previous year (Rs14bn).

Temporary and permanent damage

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.3 The National Psoriasis Foundation has a useful chart showing the potency of topical corticosteroids.4 Children are particularly susceptible.5 Side effects include hypopigmentation, atrophy of the skin, unsightly striae, telangiectasias, and secondary bacterial and fungal infections. Infections can also mask pre-existing conditions. Misuse of steroid combinations can cause bacterial or fungal resistance, which can make infections difficult to diagnose and treat.3 4 Unsupervised use of potent steroids can also lead to systemic side effects.3 5

Epidemiological evidence of the prevalence of such adverse effects is lacking in India, but dermatologists are all too familiar with the side effects of topical corticosteroid misuse. In a study of 2926 dermatology patients in 2013, for example, 433 (14.8%) were using topical corticosteroids, 392 of whom (90.5%) had adverse effects.1

More than two thirds of India’s population of about 1.3 billion people live in villages.6 India has 8500 dermatologists—just one for about 150 000 people—and about 80% practise in urban areas. Thus, many patients seek treatment for skin disease from primary care providers, including thousands of ayurvedic and homeopathic practitioners and unqualified charlatans. Although it is illegal, they may prescribe topical corticosteroids with little or no knowledge of dermatology.

Irrational combinations

Some 85% of the market (Rs13.22bn in 2014-15) comprises “steroid cocktails,” which are fixed dose combinations of topical corticosteroids and one or two antibiotics and antifungals.2 Sales of such irrational combinations grew 26% in 2014-15, compared with the previous year, when the market was worth Rs10.5bn.

The greatest increase in sales in May 2015 was of Panderm Plus Cream, which contains clobetasol, ornidazole, ofloxacin, and terbinafine. Sales of such products would be unthinkable in developed nations, but even qualified medical practitioners in India are ignorant about rational prescribing.1

In India all drug combinations are considered new drugs for the first four years and therefore need approval from the Drug Controller General of India after safety and efficacy data have been presented. After approval state licensing authorities allow manufacture and sale throughout the country.

By law strong corticosteroids, such as clobetasol, clobetasone, fluticasone, and mometasone, can be sold in India only with a registered medical practitioner’s prescription. All steroids are included in schedule H of the Drugs and Cosmetics Rules 1945, but a footnote confusingly excludes topical preparations and eye ointments from the list, even though oral forms of these drugs do not exist.7 8 This means that the status of these drugs is interpreted as “over the counter” for all practical purposes. This needs urgent revision. Moreover, existing laws are poorly implemented.7

Kligman’s formula

A modified and vitiated version of the original triple combination of Kligman’s formula, intended for use in melasma, contains potent topical corticosteroids such as mometasone in addition to hydroquinone and tretinoin, with a brand called Skinlite topping the sales in 2015. With total sales of Rs2.74bn in May 2015, these combinations are available over the counter, even though mometasone can cause severe cutaneous adverse effects. Some combination products are marketed and used as whitening creams but can cause long term and often permanent side effects.

Many of India’s 800 000 pharmacists sell steroid creams without a prescription, ignoring the box warnings.2 Patients with prescriptions often repurchase drugs and share them with friends and relatives with similar symptoms to save the cost and inconvenience of a dermatological consultation.1 The popular myth that no externally applied drug can be dangerous feeds such use.

Most developed countries restrict the sales of topical corticosteroids strictly by prescription, because they should be used judiciously, for appropriate indications and duration. The Indian government should bring topical corticosteroids, except for those with low potency, under schedule H to ensure their production and sale are regulated. The public, as well as doctors of all specialties, need to be informed and educated about safe use of topical corticosteroids. Irrational topical steroid combinations should be banned.

Task force

The Indian Association of Dermatologists, Venereologists, and Leprologists has formed a task force against topical steroid abuse, which seeks to raise public awareness, run media campaigns, form study groups for doctors, highlight the problem in journals, and meet with central and state authorities.

The task force has started to collect relevant data and has asked the drug controller to bring topical corticosteroids under schedule H, disallowing their unrestricted sale, and has demanded explanation as to why the authorities authorise irrational combinations.

This problem highlights the low priority that dermatology receives in India. The union health ministry’s drug technical advisory boards should include more dermatologists to advise the drug controller’s office and state representatives.2

Notes

Cite this as: BMJ 2015;351:h6079

Footnotes

  • I thank Koushik Lahiri, Apollo Hospital, Dermatology, Kolkata, and Abir Saraswat, InduShree Clinic, Lucknow, for their support and enthusiasm in helping with the manuscript.

  • Competing interests: I have read and understood BMJ policy on declaration of interests and have no relevant interests to declare.

  • Provenance and peer review: Not commissioned; not externally peer reviewed.

References

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