The health ministry has prohibited the over-the-counter (OTC) sale of topical medications containing hydroquinone, a bleaching agent for reducing skin pigmentation.
As per the new order, pharmacists cannot dispense ointments, creams and other dermatological applications that contain hydroquinone without the prescription of a medical practitioner with effect from April 1, 2019.
The Central Drug Control and Standards Organisation under the health ministry has slapped the ban on the OTC sale of these products to curb their indiscriminate use as a whitening agent. The government action came following a recommendation by the Drugs Technical Advisory Board, the country’s highest drug advisory body on technical matters.
The amendment to the Drugs and Cosmetics (D&C) Rules of 1945, India’s rule book on drugs and devices, to bring hydroquinone-containing ointments under Schedule H, will come into force on April 1.
Last year, the ministry had curbed the OTC sales of all pharmaceutical formulations containing steroids for external use by placing them under Schedule H of the D&C Act to stop their OTC sale.
Even though hydroquinone is widely prescribed for the treatment of hyperpigmentation, leading regulatory agencies including that of the US, EU and Japan had raised concerns about its safety profile. The USFDA on June last year proposed a ban on all OTC preparations containing hydroquinone.