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Centre to amend Rules to act against ads of prescription-only & potent drugs by sales & distribution firms
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GireeshBabu, New Delhi
December 01 , 2025
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The Central government may soon tighten the provisions under the Drugs Rules, 1945 to act against advertisement of prescription-only and potent drugs by the sales and distribution firms in various platforms, including online.
The Drugs Consultative Committee (DCC), a committee of regulatory experts from the central and the State drug control authorities, has recommended addition of provisions under the Part VI of the Drugs Rules, for sales of drugs other than homoeopathic medicines, in line with the existing provisions against advertisements under the rules applicable for manufacturing license.
The Committee's meeting held on November 17, discussed 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.
It also noted that there is already provision in the Drugs Rules for the manufacturers under the conditions of licence that no advertisement of drugs specified in Schedule H, H1 and X shall be made except with the previous sanction of the Central government.
The Committee deliberated the matter and "recommended that similar provisions may be made in the Rules for licensees holding licence for sale or distribution".
At present, Rules under the Drugs Rules for various manufacturing licenses, including those for manufacturing of drugs on their own or as loan license, and repacking of drugs under various schedules, stipulate that no advertisement of the drugs specified in Schedule H, Schedule HI or Schedule X shall be made except with the previous sanction of the Central Government.
It may be noted that the Indian drug regulation has been stringent on advertisement of high-risk and potent drugs, habit forming drugs, and psychotropic drugs. Apart from the provisions under the Drugs and Cosmetics Act, and Drugs Rules, the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, also prohibits misleading advertisements of drugs through all types of medium including online advertisements.
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