CDSCO Seeks Public Feedback on Regulating Drug Brand Name Extensions
CDSCO has invited public comments on a proposal to regulate pharmaceutical brand name extensions amid concerns that similar branding across different medicines could confuse patients and healthcare professionals.
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India’s top drug regulator Central Drugs Standard Control Organization (CDSCO) has released a proposal to regulate the practice of brand name extensions by pharmaceutical companies for public comments. The practice is feared to cause confusion among patients and healthcare professionals.
The Directorate General of Health Services (DGHS) has received several representations on use of brand name extensions by drug manufacturers, the CDSCO said in a statement. The matter was later discussed at the Drugs Consultative Committee (DCC) meeting in November 2025.
The committee was informed of a complaint received during the meeting that a pharmaceutical company was marketing a number of drug formulations with different active pharmaceutical ingredients under the same established brand name by using different suffixes or extensions. Stakeholders said this practice could mislead prescribers and patients about the therapeutic use of the medicines, and potentially compromise patient safety.
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Stakeholder Consultation:
After deliberation, the DCC recommended that the regulator should hold wider stakeholder consultations before making a final decision.
The CDSCO has taken cognisance of the recommendation and has now invited comments from pharmaceutical companies, industry stakeholders and the public on the proposed regulatory approach.
The move is part of a wider effort by the regulator to strengthen standards around drug labelling and prescribing. Rule 96 of Drugs and Cosmetics Rules states that the generic name of the drug or fixed-dose combination, other than combinations containing three or more drugs shall be boldly printed in the same font style as the brand name and in a font size of not less than two points larger.
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Further, by virtue of Rule 97, drugs containing substances specified in Schedule G are required to bear a statutory warning on the label in legible black lettering within a red rectangular box.
The regulator also reiterated that the labelling and prescribing information of similar biologics should be in accordance with the provisions of Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules and New Drugs and Clinical Trials (NDCT) Rules, 2019. The prescribing information for similar biologics should be very similar to the prescribing information for the reference biological product, with the exception of product-specific differences, particularly in the areas of dose, contraindications, warnings, and known adverse events.
