Unregulated promotion of prescription drugs fuels self-medication and antimicrobial resistance in India. Critically examine the adequacy of India's legal framework on drug advertising in light of recent amendments to the Drugs Rules, 1945.

Schedule H1 covers 3rd- and 4th-generation antibiotics and anti-TB drugs [2]. Misuse of these drugs drives antimicrobial resistance (AMR). The draft G.S.R. 861(E) of September 2026 inserts Rule 65(22) into the Drugs Rules, 1945. It extends the need for prior Central sanction to advertise Schedule H, H1 and X drugs from manufacturers to retailers, wholesalers and distributors [1]. The framework is now wider, but it still has gaps.

Strengths of the framework

• Layered law: The Drugs and Magic Remedies Act, 1954 bans misleading drug advertisements and advertisements for listed diseases [3]. A 2015 amendment made prior Central sanction compulsory for advertising Schedule H, H1 and X drugs [4].
• Accountability across the supply chain: Rule 65(22) brings licensed sellers into the rule. This curbs discount-led promotion of antibiotics and psychotropics [1].
• Expert-led, participatory rule-making: The change was recommended by the 93rd DTAB meeting in February 2026, and the public has a 30-day window to file objections [1].
• Audit trail: Every H1 sale must be entered in a separate register kept for 3 years [2].

Gaps and weaknesses

• It targets advertisements, not counter sales: Most self-medication happens when chemists sell antibiotics without a prescription. No advertisement is involved in that sale, and the chemist still profits from it.
• Centre–State split: The Centre grants the sanction, but State Licensing Authorities suspend or cancel licences under Rule 66 [5]. The draft does not require a public list of sanctions [1], so State inspectors cannot easily check whether an advertisement is legal.
• Digital blind spot: The rule covers only licence holders [1]. Unlicensed apps, aggregators and influencers fall outside it, and the DMR Act's coverage is narrow [3].
• Definitional ambiguity: The draft does not separate plain price information from promotion [1]. This could reduce price competition and raise costs for patients with long-term illnesses.
• Weak record-keeping: Ordinary Schedule H drugs have no sale register like the H1 register [2].

Overall, the framework is sound in design but weak in reach and enforcement. The final rule should:

• define "advertisement" broadly, including digital media;
• exempt plain price lists;
• publish every sanction granted;
• extend coverage to online platforms;
• pair advertising curbs with audits of H1 prescriptions.

These steps would serve Article 47's duty to improve public health and SDG 3, so that the curb on promotion actually reduces self-medication and AMR.