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DTAB asks drug regulator to amend D&C Rules to introduce license for pharma marketers
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Gireesh Babu, New Delhi
March 14 , 2026
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The Drugs Technical Advisory Board (DTAB) has recommended to the national drug regulator to amend Drugs and Cosmetics Rules, 1945, to frame rules to issue licenses to pharmaceutical marketers for monitoring and better regulatory control.
The recommendation is in line with the advice of the Drugs Consultative Committee (DCC), in its meeting held on November, 17 to incorporate the rules with various conditions in order to ensure quality and safety of products marketed in the country.
Considering the proposal for issuance of license to marketer falling under the definition of Rule 2(ea) of Drugs Rules, 1945, the DTAB in its meeting held on February 16, 2026, “recommended that Drugs Rules, 1945 may be amended by incorporating suitable provisions for issuance of license for marketers for monitoring and better regulatory control."
Earlier, while the matter came up for discussion in the DCC, the Committee was 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.
The Committee observed that provisions need to be included in the rules requiring that no marketer shall market any drug without license obtained from the licensing authority.
The Committee, after deliberations, recommended "that Rules may be amended by incorporating provisions for issuance of license for marketers by including various conditions."
According to Rule 2(ea) of the Drugs Rules, "'Marketer' means a person who as an agent or in any other capacity adopts any drug manufactured by another manufacturer under an agreement for marketing of such drug by labelling or affixing his name on the label of the drug with a view for its sale and distribution."
It may be noted that industry experts have in the past raised demand for such a move, in order to bring the pharmaceutical marketing firms also responsible for the quality, safety and efficacy of drugs they market.
While there are only around 10,500 formulation manufacturing units in the country, a large number of companies are using the facilities through outsourcing and these ‘marketed by’ are not even in the database of the departments or regulatory agencies, said an industry expert.
While the government has said that the marketing companies who manufacture with another company and market the products in India are responsible for the storage of medicine quality as per earlier notification, there is no provision for monitoring of their functions.
Since the manufacturer produces the medicine, and the distribution is by the marketing company to the nook and corner of the country, they should also have the accountability for the product and should also be brought under control, said the expert.
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