Context: The Union Health Ministry has banned over-the-counter sale of around 14 creams containing steroids and antibiotics under the Schedule H category by making amendments to certain Drugs and Cosmetics Rules, 1945.
The decision was made following consultation with the Drugs Technical Advisory Board which recommended a ban on the sale of such creams without prescription and had also submitted their recommendations to the Central Drugs Standards Control Organisation.
What necessitated this move?
The move comes in the wake of dermatologists’ complaints that pharmaceutical companies were selling steroid-based creams and ointments without medical guidance.
About CDSCO:
The Central Drugs Standard Control Organisation(CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
About DTAB:
Drugs Technical Advisory Board (DTAB) is the highest decision-making body under the Union health ministry.