In a critical move toward sharpening drug safety and regulatory clarity, the misuse and proliferation of “brand name extensions” within the pharmaceutical sector has drawn renewed focus from industry regulatory bodies. Chandrashekar Ranga, Joint Drugs Controller at the Central Drugs Standard Control Organisation (CDSCO), has highlighted the critical public health risks associated with the trend of utilizing established brand names for entirely different drug formulations.
The practice where a recognizable brand name is extended to a new combination or variation containing different active pharmaceutical ingredients (APIs) poses significant challenges to patient safety, increasing the probability of prescription errors, look-alike sound-alike (LASA) confusion, and incorrect self-medication.
Regulatory experts point out that while brand extensions offer commercial leverage to pharmaceutical companies, they can severely compromise clinical transparency. Steps are being actively advocated to mandate stricter naming conventions and more rigorous review protocols before approving brand name extensions for retail markets.
The emphasis on this regulatory loophole signals an impending push for comprehensive enforcement guidelines aimed at protecting consumer health and ensuring that every unique therapeutic formulation carries distinct, unambiguous branding.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
