Drug Marketing Firms May Soon Need Mandatory Licenses

New Delhi: The Drugs Technical Advisory Board (DTAB) has recommended amending the Drugs Rules, 1945 to introduce a formal licensing system for pharmaceutical marketers, aiming to strengthen regulatory oversight and accountability in the drug marketing sector.

During its recent meeting, the Board considered a proposal regarding the issuance of licenses to marketers who fall under the definition specified in Rule 2(ea) of the Drugs Rules, 1945.

The proposal was presented along with the recommendations made during the 67th meeting of the Drugs Consultative Committee (DCC), held on November 17, 2025.

DCC was earlier apprised that at present there is no provision for monitoring the functions of marketers to ensure quality, safety and efficacy of products marketed. In many cases, the Marketer details (address & Constitution details) are also not readily available for communication for various regulatory purposes. Provisions need to be included in the rules requiring that no marketer shall market any drug without license obtained from the licensing authority.

DCC deliberated and recommended that Rules may be amended by incorporating provisions for the issuance of a license for marketers by including various conditions.

Rule 2(ea) of the Drugs Rules, 1945 states,

"Marketer means a person who as an agent or in any other capacityadopts any drug manufactured by another manufacturer under an agreement for marketing of such drug by labeling or affixing his name on the label of the drug with a view for its sale and distribution."

After detailed deliberations, the DTAB observed that the increasing number of pharmaceutical products marketed by companies that do not directly manufacture the drugs requires clearer regulatory control. At present, such marketers often rely on third-party manufacturers while marketing products under their own brand names, creating regulatory gaps in accountability and monitoring.

The committee recommended,

"DTAB after deliberation recommended that Drugs Rules, 1945 may be amended by incorporating suitable provisions for issuance of license for marketers for monitoring and better regulatory control."