The Delhi High Court today sought the Centre's response on a plea seeking direction to ensure that no topical medications which contain a "cocktail of harmful steroids" is sold without valid prescription.
Expressing concern over the issue, a bench of Acting Chief Justice Gita Mittal and Justice C Hari Shankar issued notice to the government and the Central Drug Standards and Control Organisation (CDSCO).
It directed the authorities to place their stand before the court before the next date of hearing on January 23.
The public interest litigation (PIL) filed by the Indian Association of Dermatologists, Venereologists and Leprologists (IADVL), a leading official body of dermatologists and skin specialists, has sought a ban on the manufacture and sale of several skin creams containing steroids being marketed for skin conditions like pigmentation, itching, fairness and inflammation.
The IADVL has also sought a high-level enquiry into how the CDSCO granted approval for the commercial manufacture, use and sale of hazardous as well as irrational and unscientific steroid combinations and also ordering prosecution of the officers concerned.
The plea has contended that the government has to curb the menace of abuse of certain drugs used in treatment of skin diseases affecting the health of millions in India by enforcing the provisions of Drugs and Cosmetics Act.
"The 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 PIL said.
It stated that potent topical corticosteroids are being misused in the country in the name of treating bacterial or fungal infections, lightening skin colour for fairer complexion, suppressing itchy or painful skin rashes, regardless of their underlying cause.
"Some major adverse effects are growth retardation in infants and children, Cushing syndrome, suppression of hypothalamic pituitary adrenal axis, acute adrenal insufficiency, severe hard to treat steroid modified fungal infection of the groin and other body areas, male genital dermatophytoses, topical steroid damaged face," it said.
It also said that supposedly herbal creams such as Meglow Premium fairness cream and Pearl Beauty Whitening fairness cream also contained steroids.
"In spite of the fact that these drugs can cause such serious adverse effects, they are sold without medical prescription or control and there is little awareness about the adverse effects among the general public," it said, adding that no other country in the world has this combination but there are numerous brands in India which were selling such combination.
Many of India's 800,000 pharmacists sold steroid creams without prescription, ignoring the box warnings, it added.
The plea sought direction for government to include in Schedule H of the Drugs and Cosmetic Rules 1945, the hazardous steroid molecules as proposed by Drugs Technical Advisory Board.
Schedule H is the category of drugs which need to be dispensed only through a prescription and not over the counter and cannot be advertised.
The sale of steroid creams is over half a billion dollar business, with almost two-thirds of which are sold without prescription.
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