CDSCO bans OTC sale of topical medications containing hydroquinone from April 1, 2019

New Delhi: Effective from April 1, the pharmacies in the country will have to halt the sale of topical medications containing hydroquinone, a bleaching agent for reducing skin pigmentation, without a doctor's prescription.

This comes after a recent Gazette notification, the Central Drug Standards and Control Organisation (CDSCO) imposed a ban on over the counter (OTC) sale of medicines containing hydroquinone.

In exercise of the powers conferred under sections 12 and 33 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board has imposed the ban on OTC sale of these products. The Drugs Technical Advisory Board is the country's highest drug advisory body on technical matters.

The move will help curb the indiscriminate use of hydroquinone. 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.

Prior to this, copies of the Gazette were made available to the public on the 26th September 2018. However, no objections or suggestions were received from the public on the said rule for consideration by the Central Government.

Thereby, an official notification has been release wherein amendment to the Drugs and Cosmetics (D&C) Rules of 1945 to bring hydroquinone-containing ointments under Schedule H has been made.

The notice reads;

"In the Drugs and Cosmetics Rules, 1945, in Schedule H, in the Note appended thereto, in paragraph 4, for the word 'steroids', the words "steroids or Hydroquinone" shall be substituted."

Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945 introduced in 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. The manufacture and sale of all drugs are covered under the Drugs and Cosmetics Act and Rules.

Medical Dialogues had earlier reported that the public interest litigation (PIL), filed by the Indian Association of Dermatologists, Venereologists, and Leprologists (IADVL), had sought a ban on manufacture and sale of several skin creams containing steroids being marketed for skin conditions like pigmentation, itching, fairness, and inflammation.

The plea had contended that the government has to curb the menace of abuse of certain drugs used in the treatment of skin diseases affecting the health of millions in India by enforcing the provisions of Drugs and Cosmetics Act.

Also Read: Misuse of Topical Steroid Skin Creams: Delhi HC notice to CDSCO

Deliberating the concern, 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.

It is reported that dermatologists are of the opinion that mere regulating the sale of these products is not enough, Government should outrightly ban all irrational combinations.

It is further reported that presently several depigmenting skin creams containing hydroquinone are available in the Indian market, and many can be purchased online. The products include Wockhardt's Depiwhite and Abbott's Melalite 15 Cream.

However, 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 reportedly 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.

Also Read: Suprise Visit check by CDSCO finds banned Oxytocin in East Delhi