In a move that could make it safer for patients to know exactly what medicine they are taking, India’s apex drug regulatory body has sought comments aimed at curbing a confusing pharmaceutical marketing practice of selling different drugs under near-identical brand names.
“The change under consideration could matter a lot for the common man as many people recognise medicines by their brand name rather than their chemical composition, and often assume products sharing a name are variations of the same treatment,” said a person in the know. “If a company sells one drug under a brand name and another drug with a completely different active ingredient under a slight variation of that same name, patients or even pharmacists could easily pick up the wrong product or fail to realise two similarly named medicines treat entirely different conditions.”
Tightening the rules around this practice, known as brand name extension, is intended to reduce mix-ups, prevent accidental misuse of medication, and help the public trust that a familiar brand name reliably points to a familiar treatment, he said.
The Central Drugs Standard Control Organisation (CDSCO) issued a notice on July 6, inviting stakeholders to comment on how such branding practices should be regulated going forward.
The move gains significance as the regulator had received representations alleging that some pharmaceutical companies were selling several drug formulations under a common brand name, distinguished only by suffixes or add-ons, despite the products containing different active pharmaceutical ingredients.
People in the government say that this could mislead patients and healthcare providers, potentially causing confusion about a medicine’s actual therapeutic use, a risk that could translate into real harm if a consumer assumes two similarly named products treat the same condition.
The matter was discussed by the Drugs Consultative Committee (DCC) at a meeting held in November last year. Experts at the DCC reviewed the complaints and concluded that broader stakeholder input was needed given the multiple dimensions of the issue, including consumer safety, industry branding practices and existing labelling regulations.
The CDSCO has asked stakeholders including pharmaceutical companies, healthcare professionals, industry associations, and the public to submit comments by July 17.
