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The Union Health Ministry has banned over-the-counter sale of 14 products.
FACTS FOR PRELIMS
To prevent the indiscriminate sale of ointments containing steroids and antibiotics without prescription, over-the-counter sale of 14 such products were banned. The preparations were included under the Schedule H of the Drugs and Cosmetics Rules, 1945, in a notification issued on March 23.
The decision was taken following consultation with the Drugs Technical Advisory Board, which had recommended a ban on the sale of such creams without a prescription and also submitted their recommendations to the Central Drugs Standards Control Organisation.
Schedule H Drugs
It 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. It is revised at times based on the advice of the Drugs Technical Advisory Board, part of the Central Drugs Standard Control Organization in the Ministry of Health and Family Welfare.
Central Drugs Standard Control Organization (CDSCO)
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when needed.