India's health ministry has proposed extending existing advertising restrictions on Schedule H, H1, and X drugs to chemists, wholesalers, and distributors, requiring central government approval before promoting potent prescription medicines such as antibiotics, hormonal preparations, psychotropic drugs, anti-cancer medicines, narcotics, and life-saving injectables.
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Existing Drugs and Cosmetics Rules already require prior government sanction for advertisements of Schedule H, H1, and X drugs, which include potent prescription medicines such as antibiotics, hormonal preparations, psychotropic drugs, anti-cancer medicines, narcotic drugs, and life-saving injectables.
NEW DELHI: Chemists, wholesalers and drug distributors may soon have to seek Centre's approval before advertising certain prescription medicines, with health ministry proposing to extend existing curbs on advertisements of Schedule H, H1 and X drugs to those involved in their sale and distribution. The proposal assumes significance as regulators have raised concerns over promotion of potent prescription medicines, including antibiotics, hormonal preparations, psychotropic drugs, anti-cancer medicines, narcotic drugs and life-saving injectables. The ministry has now proposed inserting a new sub-rule under Rule 65 of Drugs Rules, 1945, stating no advertisement of drugs specified in Schedule H, H1 or X shall be made without previous sanction of central govt. The provision would apply to those holding licences to sell, stock, exhibit, offer for sale or distribute such drugs. Importantly, the proposal does not mean that advertisements of these medicines are currently freely permitted. Drugs and Cosmetics Rules already require prior govt sanction for advertisements of Schedule H, H1 and X drugs.
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