On July 6, 2026, the Central Drugs Standard Control Organisation (CDSCO) released a public notice asking stakeholders to share their views on the use of established pharmaceutical brand names with different extensions across multiple drug formulations, signalling a renewed regulatory focus on pharmaceutical branding and patient safety. While the consultation does not propose an immediate regulatory change, prohibition, or binding direction, it indicates CDSCO’s concern that using the same core brand name for medicines with different active pharmaceutical ingredients (APIs) could confuse patients, healthcare professionals, and pharmacists, thereby raising the risk of medication errors.
The consultation follows the recommendation of the 67th Drugs Consultative Committee (DCC) held on November 17, 2025, during which the committee discussed concerns arising from a representation alleging that a pharmaceutical company was marketing several drug formulations under the same brand name with different suffixes. The Committee noted that the use of identical or similar brand names for medicines with different active ingredients may mislead consumers about their therapeutic uses and recommended that CDSCO seek stakeholder input before making any regulatory changes.
This issue is important because pharmaceutical branding occupies a unique position at the intersection of intellectual property law and drug regulation. Unlike most consumer products, medicines are usually known by their brand names, making pharmaceutical nomenclature directly important to patient safety. Patients often recognise medicines by their brand names; pharmacists rely on brand names to fill prescriptions; and healthcare professionals often prescribe medicines by brand name. Thus, using a common root brand for products intended for different therapeutic uses or containing different APIs may lead patients to believe that such medicines are different strengths or dosage forms of the same product. In clinical settings, especially with handwritten prescriptions, verbal instructions, or similar packaging, this confusion can lead to dispensing or prescribing errors, which may have serious consequences.
This issue has attracted regulatory and public-health attention over the past two years. Public concern grew in 2024 after reports showed that medicines from different therapeutic areas were being sold under the identical or confusingly similar brand names. A reported example is the use of the brand name “Linamac” for products meant to treat entirely different medical conditions, raising concerns over patient safety. The matter reportedly drew the attention of the National Human Rights Commission (NHRC), which took suo motu cognisance, stating that if these practices were confirmed, they could pose serious public health risks. In this context, the present consultation reflects CDSCO’s ongoing efforts to examine whether existing regulations are effective in addressing the risks associated with pharmaceutical brand extensions.
While the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, do not specifically prohibit the use of common brand names with different extensions, the statutory framework is primarily designed to ensure the safety, efficacy, and quality of medicines marketed in India. The DCC is a statutory advisory body constituted under Section 7 of the Drugs and Cosmetics Act, 1940, to advise the Central and State Governments on matters requiring uniform implementation of the Act and the Rules framed in the Act. The recommendation to hold a stakeholder consultation is an important step in determining whether additional safeguards are needed to prevent confusion arising from pharmaceutical nomenclature.
This consultation builds on earlier DCC recommendations regarding pharmaceutical brand approvals. Noting the rise in look-alike and sound-alike brand names, the Committee had suggested that the database of approved drug brand names available on the Sugam Portal be made accessible to the public. It was also recommended that, when companies furnish Form 51 undertaking for marketing a drug under a brand name or trade name under the Drugs Rules, 1945, the concerned State Licensing Authorities (SLAs) should verify the proposed names against the Sugam database, the TradeMarks Registry, and other sources to ensure similar names do not already exist. The DCC also advised that manufacturers upload formulation details, along with approved brand names, to the Sugam Portal, as required by Rule 84AB of the Drugs Rules, 1945, to help create a complete national database for regulatory review and to avoid duplication in pharmaceutical branding.
The Committee also suggested that if identical brand names are already in use, the manufacturer who first submitted Form 51 may be permitted to continue using the brand name, while later conflicting approvals may be reviewed by the the State Licensing Authorities. Where Form 51 does not apply, the decision should be based on the regulatory approval history kept by the licensing authorities. These recommendations show that the regulator aims for clarity and consistency in pharmaceutical naming, not just trademark ownership.
The consultation also supports the broader regulatory objective of ensuring accurate identification medicinal products throughout the supply chain. This initiative also aligns with the broader objective of preventing misleading claims regarding medicinal products, which remains a key feature of the regulatory framework under the Drugs and Cosmetics Act.
The consultation also highlights the difference between trademark protection and regulatory approval. Under the Trade Marks Act, 1999, registering a pharmaceutical trademark gives the proprietor exclusive rights to use the mark for certain goods and protects the brand’s commercial reputation. However, trademark registration does not automatically allow a manufacturer to market a medicine under that name. Drug regulators evaluate pharmaceutical brand names from a different perspective: whether the proposed name is likely to create confusion regarding therapeutic indications, active ingredients, or its intended use. Accordingly, pharmaceutical companies must ensure that their branding strategies meet both trademark law requirements and the independent regulatory requirements set by CDSCO and State Licensing Authorities.
For the pharmaceutical industry, this consultation is a reminder that managing brands now requires combining intellectual property, regulatory compliance, and patient safety. Companies using brand name extensions or common root brands across multiple therapeutic areas may need to review their product portfolios if stricter rules on brand names are introduced. Greater emphasis may also be placed on due diligence before adopting new pharmaceutical brands, including an assessment of existing regulatory approvals and the potential for therapeutic confusion in addition to standard trademark clearance.
Although CDSCO has not yet proposed any amendments to the existing regulatory framework, its decision to initiate a public consultation reflects a proactive and consultative approach to addressing an important public health issue. The results of this consultation could influence future rules governing pharmaceutical brand approvals, improve coordination among State Licensing Authorities, and make digital tools like the Sugam Portal more effective in preventing confusing or similar brand names. Ultimately, the initiative reinforces that while pharmaceutical brands are valuable commercial assets, they also play a key role in public health, and their adoption must balance commercial interests with the main goal of keeping medicines safe and effective. The final regulatory position will depend on stakeholder comments and any further action by CDSCO or the government.
Authors: Manisha Singh and Kratika Patel