Govt Bans OTC Sale Of Skin Medications Containing Hydroquinone

New Delhi, 11 March 2019: Come April and pharmacies in the country have to stop selling topical medications containing hydroquinone, a bleaching agent for reducing skin pigmentation, without a doctor’s prescription. The health ministry has imposed the ban on over-the-counter (OTC) sale of these products to curb their indiscriminate use.

The amendment to the Drugs and Cosmetics (D&C) Rules of 1945 to bring hydroquinone-containing ointments under Schedule H will come into force on April 1. The government action came following a recommendation by the Drugs Technical Advisory Board, the country’s highest drug advisory body on technical matters.

Hydroquinone -- sometimes termed Benzene 1,4-diol or quinol -- is usually found in bleaching creams, skin lighteners, pigment gels, spot treatments and many popular anti-aging products. The chemical is added to work as a primary ingredient in the function of lightening a person’s skin.

Currently, several depigmenting skin creams containing hydroquinone are available in the Indian market, and many can be bought online. The products include Wockhardt’s Depiwhite and Abbott’s Melalite 15 Cream. 

Last year, the ministry had placed all pharmaceutical formulations containing steroids for external use under Schedule H of the D&C Act to stop their OTC sale. Hydroquinone is also added to the list now after several cases have shown that its unchecked sale is leading to adverse effects on skin such as redness, inflammation, rashes and discolouration. The government has brought all steroid-laced creams under Schedule H following a public interest litigation filed in the Delhi High Court by Indian Association of Dermatologists, Venereologists and Leprologists (IADVL), seeking a ban on manufacture and sale of skin creams potentially harmful ingredients.

However, regulating sales is not enough in the case of these products, say dermatologists. “The government should outrightly ban all irrational combinations. These creams are often used without medical guidance for itching, acne, minor infections and fairness, and even beauticians prescribe them. Thanks to lack of regulatory oversight, we are seeing an epidemic of fungal infections,” says Dr Ramesh Bhatt, eminent skin specialist and president of IADVL stated.

This view is echoed by other clinicians. “It is important that long term use of medicines for skin problems must be under prescription from a qualified doctor. Hydroquinone-containing medications should not be sold over the counter, they must be used only for serious skin ailments,” Delhi-based dermatologist Dr Mudasir Rashid Khan opined. 

According to industry observers, many of these creams are not allowed to be made or sold in the developed world. Several countries including the US, Japan and Australia have either banned or imposed regulations on the OTC sales of hydroquinone products. Back in 2016, the West African country of Ghana imposed a complete ban on the import and sale of hydroquinone citing rampant misuse. Pharmabiz