In order to address the concerns over sale of steroid or other prescription-drugs-based skin creams advertised and sold without prescription for cosmetic and skin problems, government has considered the proposal to amend abolishing a footnote in the country's rule book on medicines that currently exempts skin creams from being labeled as Schedule H drugs.
The recommendation for such an exemption is in view of the consideration of the proposal made by the Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) to amend note appended to Schedule H omitting exemption for topical or external use for steroid preparations from the provisions of Schedule H drugs during the recent Drugs Technical Advisory Board (DTAB) meet held in Delhi.
IADVL had made a representation to the office of Drug Controller General of India (DCGI) regarding the adverse effects induced by rampant misuse of creams containing cortico-steroids along with antibiotics and anti-fungals causing damage to the skin of Indian citizens.
Increasing numbers of cases of Topical Steroid Damaged Face (TSDF) and steroid modified recalcitrant and/or extensive tinea (fungal infection of the skin known as ringworm) have come to the notice of the dermatologists.
These creams are purchased and used by the patients without any doctor's prescription as Schedule H provided exemption for topical or external use preparations from the purview of Schedule H and H1, in the note appended to these Schedules.
In order to prevent over the counter sale of topical preparations containing steroids and antibiotics, it was proposed to amend the note which states, "The salts, esters, derivatives and preparations containing the above substances excluding those intended for topical or external use (except preparations containing steroids) are also covered by this Schedule."
The footnote exempting skin creams from the Schedule H tag is a Rs. 1,500 crore annual market for skin creams that contain steroids and other prescription medications.
Dermatologists had complained to the government that the exemption allowed pharmaceutical companies to sell potentially dangerous medications that may cause harm to patients who, unaware of their side effects, use them without medical guidance.
The revised rule will apply only to skin creams that contain steroids or other prescription drugs. It will not apply to ordinary face-cleansing and fairness creams and moisturisers.