nOintments containing hydroquinone, a strong bleaching agent used for reducing skin pigmentation, have been banned from being sold Over-the-Counter (OTC) in India from April 1, 2019 as their unchecked usage can cause redness, inflammation and discolouration and in the long run permanent blemishes.
It means that ointments containing hydroquinone as ingredients will not be sold without a doctor’s prescription from next month. Dermatologists have been using it for the treatment of freckles, melasma (butterfly shaped blemishes) and general brown patching. Worldwide, hydroquinone is still the most commonly used bleaching agent.
Sources in the Union Health Ministry said that 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, 2019. The move follows a recommendation by the Drugs Technical Advisory Board, the country’s highest drug advisory body on technical matters.
Hydroquinone is a prescription drug all across for long. But in India, it was not a prescription drug, so any company would put the substance as ingredient and sell it to anybody. In other words, any skin-lightening products containing hydroquinone has been brought under the Schedule H of the Drug and Cosmetic Rules.
The products would require DCGI approval before being sold to the public and would only be available with a doctor’s prescription, explained Dr Mukesh Girdhar, Vice President, Indian Association of Dermatologists, Venereologists and Leprologists (IADVL). “The chemist cannot give it to anybody without prescription. Its usage can cause irritation, rash while over-use or long term usage can damage the skin which cannot be treated,” he cautioned about its unchecked usage.
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 following a public interest litigation filed in the Delhi High Court by the IADVL, seeking a ban on manufacture and sale of skin creams potentially harmful ingredients.
Some studies also report abnormal function of the adrenal glands and high levels of mercury in people who have used hydroquinone-containing cosmetics. For these reasons, hydroquinone has already been banned in Japan, the European Union, and Australi while the US has imposed regulations on its OTC sales, according to a report.
