Health Ministry May Require Licenses for Drug Marketers

The Union health ministry's Drugs Consultative Committee (DCC) has advised the government to modify the Drugs and Cosmetic Rules (D&C Rules) to grant licenses to pharmaceutical marketers under specific conditions aimed at guaranteeing the quality and safety of products sold in the country.

 In a hybrid format, addressed the issue and suggested an amendment to the Drugs Rules accordingly. The DCC was informed that currently there is no mechanism in place to oversee the activities of marketers to guarantee the quality and  safety, and effectiveness of products sold. Often, the marketer's information (address and constitution details) is also not easily accessible for communication for several regulatory reasons.

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The Committee noted that the rules must incorporate provisions stating that no marketer can promote any Pharmaceutical drugs without a license acquired from the licensing authority. The Committee, following discussions, suggested "that Rules could be modified to include provisions for granting licenses to marketers by adding several conditions."

As per Rule 2(ea) of the Drugs Rules, "'Marketer' refers to an individual who, as an agent or in any other role, endorses any drug produced by another manufacturer under a marketing agreement by labeling or placing his name on the drug's label for the purpose of selling and distributing it." It should be noted that industry experts previously called for such an action to make pharmaceutical marketing companies accountable for the quality, safety, and effectiveness of the drugs they promote.