DCGI to revamp medicine packaging and labelling regulations

The Drug Controller General of India (DCGI) is spearheading a nationwide revamp of medicine packaging and labelling regulations to enhance patient safety, affordability, and transparency. The proposed changes aim to make critical information more legible, streamline the distinction between generic and branded drugs, and empower consumers with better-informed choices.

Government officials familiar with the development indicate that manufacturers may soon face mandates to adopt larger fonts, abandon reflective, shiny packaging materials that obscure print, and print expiry dates in multiple locations to prevent crucial details from being torn off or becoming illegible.

A key highlight of the proposed reforms is the planned introduction of a universal symbol explicitly designed to differentiate generic medicines from their branded counterparts. This comes in response to numerous complaints received by the regulator concerning the difficulty consumers face in discerning the more affordable generic options from their often pricier branded versions, hindering effective price comparisons.

A dedicated subcommittee established by the DCGI is currently reviewing these comprehensive proposals and is anticipated to submit its report shortly. This committee is also tasked with exploring the necessary amendments to the Drugs and Cosmetics Rules, 1945, the foundational legislation governing drug quality, manufacture, import, and sale in India.

The initiative holds substantial significance for India, a global powerhouse in generic drug manufacturing, accounting for approximately 20% of the world's supply and producing around 600 generic brands across 60 therapeutic categories. While both generic and branded medicines contain the same active ingredients and are expected to deliver identical therapeutic effects, their primary distinctions lie in cost, brand recognition, and patent status. Branded drugs, often bolstered by extensive marketing, typically command a higher price point, whereas generics offer a more budget-friendly alternative, often up to 80% cheaper, owing to their post-patent manufacturing without the burden of costly R&D.

Currently, international labels frequently use symbols like "Rx" to denote prescription-only medication, with its absence indicating an over-the-counter (OTC) drug. India's new symbol for generics could follow a similar intuitive approach.

While the pharmaceutical industry acknowledges potential logistical adjustments in updating their packaging lines, there is a consensus that these impending changes will yield a profoundly positive impact on patient welfare, affordability, and overall market transparency.