The Union Ministry of Health and Family Welfare has proposed stricter regulations on prescription drug advertisements in India, seeking to extend existing restrictions beyond pharmaceutical manufacturers to include pharmacies, wholesalers and other licensed drug sellers.
Under the draft rules, advertisements for medicines listed under Schedules H, H1 and X of the Drugs Rules, 1945, would require prior approval from the Central Government before they can be promoted.
At present, such restrictions primarily apply to pharmaceutical companies manufacturing these medicines.
Draft Rules Expand Prescription Drug Advertising Restrictions
The ministry has proposed inserting a new sub-rule (22) under Rule 65 of the Drugs Rules, 1945, to widen the scope of the regulation. The amendment would cover entities licensed to sell, stock, exhibit, offer for sale or distribute drugs, bringing retail medical stores and wholesale drug dealers under the ambit of advertisement controls.
The move is aimed at strengthening oversight across the pharmaceutical supply chain and preventing the unauthorised promotion of prescription medicines.
Officials believe the proposed changes will help reduce the risk of self-medication and ensure that medicines requiring professional medical supervision are not marketed directly to consumers without adequate safeguards.
Schedules H, H1 and X Medicines Under Focus
The ministry noted that the proposal is particularly relevant for medicines covered under Schedules H, H1 and X, which include several antibiotics, psychotropic substances and other drugs that can only be dispensed against a valid prescription. Schedule H alone covers more than 500 medicines commonly used in medical treatment.
Proposal Follows Drugs Technical Advisory Board Recommendations
The draft amendment follows recommendations made during the 93rd meeting of the Drugs Technical Advisory Board (DTAB) held in February this year.
The board had discussed the need for explicit legal provisions to regulate advertisements by license holders engaged in the sale and distribution of drugs, in addition to manufacturers.
Stakeholders and members of the public have been invited to submit objections and suggestions within 30 days from the date copies of the Gazette containing the draft rules are made available.
Health Ministry Also Proposes CCTV Surveillance at Medical Stores
The proposal comes amid broader efforts by the government to tighten controls over the sale of prescription medicines. Last month, the Health Ministry proposed making CCTV surveillance mandatory at all medical stores, with recordings required to be preserved for at least three months. The measure is intended to curb unauthorised access to Schedule H, H1 and X medicines and prevent their sale without valid prescriptions.
If notified, the proposed amendments are expected to strengthen regulatory safeguards around prescription drugs and enhance accountability across the drug distribution network.
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