To curb the indiscriminate over-the-counter (OTC) sale of fairness creams containing hydroquinone, a bleaching agent, the Drugs Technical Advisory Board (DTAB), the country’s highest drug advisory body on technical matters, has cleared a proposal to amend an appended footnote to bring such products also under Schedule H of the Drugs and Cosmetics (D&C) Act.
The Union health ministry had earlier issued a notification that pharmaceutical formulations containing all kinds of steroids “for topical or external use” shall, from November 1, 2018, be covered under Schedule H of the D&C Act. Now, the proposal cleared by the DTAB would add formulations containing hydroquinone — sometimes termed Benzene-1,4-diol or quinol – also to the list of prescription drugs. All medications under Schedule H can only be sold by chemists on prescriptions of registered medical practitioners.
Hydroquinone is usually found in bleaching creams, skin lighteners, pigment gels, spot treatments and many popular anti-aging products. The chemical is generally added to work as a primary ingredient in the function of lightening a person’s skin.
The drug technical body “deliberated and agreed to the proposal to amend the Note appended to Schedule H of D&C Rules, 1945 to curb the misuse of preparation containing hydroquinone,” the minutes of the meeting of the DTAB on July 25.
“In view of the above, the paragraph 4 in the Note appended to Schedule H shall be substituted as follows: The salts, esters, derivatives and any preparations containing steroids and/or hydroquinone for topical or external use shall be covered by this schedule,” it further stated.
The government, in a notification issued on April 26, brought steroid-laced creams under Schedule H to address concerns expressed by dermatologists. Some ointments on the list are alclometasone, beclomethasone, desonide and fluocinonide. The action was prompted by a public interest litigation (PIL) filed in the Delhi High Court by Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) seeking ban on manufacture and sale of several skin creams containing steroids being marketed for conditions like pigmentation, itching, fairness and inflammation. Expressing concern over the issue, the court sent notices to the government and the Central Drugs Standard Control Organisation. The government had then assured the court that the relevant rules would be amended in two weeks’ time.
Top dermatologists, however, stressed that the inclusion of steroid-laced creams and hydroquinone preparations in Schedule H was only a small positive step. “What we want is an outright ban on the irrational combinations of skin creams. In this country, many steroid-laced creams are still used without medical guidance for itching, acne, minor infections and even fairness. And thanks to lack of regulatory oversight, we are seeing an epidemic of hard-to-treat fungal infections,” President of IADVL Dr Ramesh Bhatt said.
“Unchecked and unregulated manufacturing and sale of irrational, unscientific and hazardous corticosteroids, either in form of a single molecule or in combination with other anti-fungals or antibacterials, has caused serious adverse effects on the health of millions of Indians,” the doctors’ body stated in the PIL.
“These steroid-containing skin creams are usually prescribed for skin disorders such as melasma, the emergence of dark patches. But they are recommended even by beauty parlours. Many of these creams are not allowed to be made or sold in the developed world. The next hearing on our PIL is on August 24. We will continue our campaign to banish such harmful skin creams from the Indian market,” Dr Bhatt added.
