Drug Advertisement: According to the proposal, prior permission from the central government would be required to advertise these drugs. This restriction currently applies to pharmaceutical companies under existing regulations.

New rules on prescription drug advertising

Govt Stricters Rules on Prescription Drug Ads: The central government has proposed tightening regulations regarding the advertising of prescription drugs. The Union Ministry of Health and Family Welfare has released a draft amendment to the Drugs Rules, 1945. Under this amendment, restrictions on advertising drugs included in Schedules H, H1, and X are proposed to be extended to retailers, wholesalers, and distributors.

According to the proposal, prior permission from the central government will be required to advertise these drugs. Currently, this restriction applies to pharmaceutical companies under existing regulations, but licensees engaged in retail and wholesale sales of drugs were not explicitly included in its scope. The government says that changes to the regulations have been proposed to address this shortcoming.

What changes does the government want to make in the Drugs Rules, 1945?

The Ministry of Health notified the draft amendment through Gazette Notification GSR 861(E) dated September 28, 2026. This proposal emerged after consultation with the Drugs Technical Advisory Board (DTAB). The Ministry has proposed to add sub-rule (22) to Rule 65 of the Drugs Rules, 1945. Under this, the advertising restrictions will also apply to licensees licensed to sell, stock, exhibit for sale, offer for sale, or distribute drugs. This will include both retail and wholesale drug dealers.

According to the proposed provision, drugs listed in Schedule H, Schedule H1, and Schedule X cannot be advertised without prior approval from the central government. However, this change is currently in the form of a proposal. The government is seeking suggestions and objections from stakeholders before finalizing it.

Which drugs will the proposed rules apply to?

Schedules H, H1, and X include drugs that must be dispensed only on prescription under established regulations. These include certain antibiotics, drugs with psychotropic effects, and other prescription drugs. These drugs must be used under appropriate medical advice and supervision. The government's proposal aims to prevent unauthorized marketing and reduce the risks associated with using drugs without proper medical advice.

According to the ministry, extending advertising regulations to the entire pharmaceutical supply system will strengthen regulatory oversight. It seeks to bridge the gap between the current restrictions on pharmaceutical companies and the provisions for licensees who sell or distribute medicines.

This issue was raised in the 93rd meeting.

Prior to this proposal, the subject was also discussed at the 93rd meeting of the Drugs Technical Advisory Board, held on February 16, 2026. The meeting considered the need for appropriate provisions to regulate advertisements by individuals and institutions licensed to sell and distribute medicines. Following this, the Ministry of Health drafted amendments to the regulations. The proposal aims to apply advertising regulations to pharmaceutical companies as well as businesses that sell, stock, or distribute medicines.

Suggestions sought from parties

The Ministry of Health has invited objections and suggestions from the public and stakeholders on this proposal. Suggestions and objections can be submitted within 30 days from the date copies of the draft rules are made available to the public in the Gazette. The Central Government will consider the suggestions and objections received within the stipulated period. The process of finalizing the amendments will then proceed.