Draft Drugs Rules amendment extends prescription-drug ad curb to chemists
The Union Ministry of Health and Family Welfare has proposed amending the Drugs Rules, 1945 so that chemists, wholesalers and distributors cannot advertise Schedule H, Schedule H1 and Schedule X drugs without the Central Government's previous sanction. The draft, dated September 28, 2026, is open for objections and suggestions for 30 days. Manufacturers already face this restriction.
Syllabus: GS2 · Statutory & Regulatory Bodies; GS2 · Government Policies; GS2 · Health, Education & Human Resources
Why it matters
A patient who sees a pharmacy advertising an antibiotic or a psychotropic medicine, often with a large discount, may buy it without seeing a doctor. The Health Ministry says the draft is meant to discourage unauthorised promotion of prescription medicines and reduce inappropriate self-medication. A senior government official said it would help curb the misuse of antibiotics, which fuels antimicrobial resistance: bacteria stop responding to the drugs meant to kill them. If the draft is finalised, a chemist, a wholesaler or a distributor would need the Central Government's sanction before advertising such drugs, as a manufacturer already does. The All India Organization of Chemists and Druggists welcomed the proposal, saying online pharmacies advertise very large discounts.
Prelims pointers
- Drugs and Cosmetics Act, 1940: regulates the import, manufacture, distribution and sale of drugs and cosmetics; the Drugs Rules, 1945 are made under it.
- Drugs Technical Advisory Board: statutory body under Section 5 of the 1940 Act; advises the Central and State Governments on technical matters arising from the Act.
- Schedule H: prescription drugs; sold by retail only on the prescription of a registered medical practitioner, with the Rx symbol on the label.
- Schedule H1: notified in 2013; the chemist enters the prescriber, patient, drug and quantity in a separate register kept for three years.
- Schedule X: habit-forming psychotropic drugs; the prescription is in duplicate and the chemist keeps one copy for two years.
- Central Drugs Standard Control Organisation: under the Directorate General of Health Services, Health Ministry; headed by the Drugs Controller General of India.
- Seventh Schedule: "Drugs and poisons" is in the Concurrent List; "Public health and sanitation" is in the State List.
- Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954: bans advertisements of drugs for diseases listed in its Schedule and of magic remedies.
Practise a UPSC-style question
With reference to the draft amendment to the Drugs Rules, 1945 on drug advertisements published in 2026, consider the following statements:
1. It has been proposed by the Ministry of Chemicals and Fertilizers.
2. It would apply to holders of licences to sell, stock or distribute drugs, including retailers and wholesalers.
3. It would require the previous sanction of the Central Government for advertising Schedule H, Schedule H1 and Schedule X drugs.
Which of the statements given above is/are correct?
- (a) 1 and 2 only
- (b) 2 and 3 only
- (c) 1 and 3 only
- (d) 1, 2 and 3
Show the answer
Answer: (b) 2 and 3 only
1 is incorrect: the draft was published by the Union Ministry of Health and Family Welfare, not the Ministry of Chemicals and Fertilizers. 2 is correct: the proposed sub-rule sits in Rule 65, which governs sale licences, so it would reach retail and wholesale licence holders. 3 is correct: the draft says no advertisement of these drugs shall be made except with the previous sanction of the Central Government.
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