No Ads for High-Risk Medicines: Govt Panel Recommends Major Amendments to Drugs Rules 1945

New Delhi: In a significant move aimed at tightening regulatory control over the promotion of high-risk medicines, the Drugs Consultative Committee (DCC) has recommended amendments to the Drugs Rules, 1945, to prohibit sales and distribution license holders from advertising prescription-only and potent drugs.

The proposal emerged during the DCC’s meeting held on November 17, where the panel reviewed the proposal for amendment in rules under Chapter VI Sales of Drugs other than Homeopathic medicines with respect to advertisement.

The Committee expressed concern that advertisements for potent and specialized drugs such as antibiotics, hormonal preparations, injectables, psychotropic medicines, oncology drugs, and narcotic substances are increasingly appearing on various platforms without adequate oversight.

DCC was apprised about the concern over the widespread and unchecked advertisement of prescription-only and potent drugs, including life-saving injectables, antibiotics, hormonal preparations, psychotropic substances, anti-cancer drugs, and narcotic drugs.

DCC noted that there is already a provision in the Drugs Rules for the manufacturers under the conditions of license that no advertisement of drugs specified in Schedules H, H1, and X shall be made except with the previous sanction of the Central Government.

Earlier, the Medical Dialogues Team reported that the government initiated steps to clamp down on the online advertising of high-risk prescription medicines. The proposal was to amend the Drugs and Cosmetics Rules, 1945, making it mandatory for every drug license to explicitly prohibit advertisements for Schedule G, H, H1 and X medicines.

DCC deliberated the matter and recommended that similar provisions be made in the rules for licensees holding licenses for sale or distribution.