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Indian pharmaceutical companies have taken note of the Central Drugs Standard Control Organisation’s (CDSCO) recent labelling reforms, viewing them as a constructive step toward building a more globally aligned pharmaceutical ecosystem.
Saransh Chaudhary, president, global critical care, Venus Remedies and CEO, Venus Medicine Research Centre pointed out that better labelling can drive India’s push for safer and globally competitive pharma products. To this end, the recent decision by CDSCO is a long-awaited step that could meaningfully reshape how patients interact with medicines in India and abroad.
Clear, consistent, and intelligible labelling is fundamental to safe medicine use, and this regulatory review presents a much-needed opportunity to address gaps that have persisted for years. Once the conversation turns to labelling, it inevitably broadens to encompass pharmaceutical packaging as a whole, particularly in hospital and critical-care settings where even small errors can have serious consequences, he added.
Concerns around labelling and packaging have been repeatedly raised. Over time, issues such as cluttered label layouts, inconsistent placement of critical safety information, and packaging that is difficult for patients or caregivers to interpret have become all too familiar. These challenges are not merely aesthetic. They directly affect how medicines are prescribed, dispensed, and ultimately used, Chaudhary told Pharmabiz.
In the highly regulated world of pharmaceuticals, packaging is not just a functional requirement. It is the first line of defence in preserving a medicine’s efficacy, stability, and safety. When patients or healthcare professionals struggle to locate dosage instructions, expiry dates, or key warnings, the risk to patient safety arises even before treatment begins. In this context, the CDSCO’s move to reassess labelling standards should be seen as an opportunity to shift decisively toward a more patient-centric approach, he pointed out.
Globally, regulators have long recognised that labelling and packaging play a critical role in ensuring safe and effective medicine use. While frameworks differ by jurisdiction, the underlying objective is to protect patients, maintain product integrity, and reduce the risk of errors or counterfeiting.
US FDA, through the Drug Supply Chain Security Act, places strong emphasis on traceability, tamper evidence, and clear product identification across the supply chain. European Medicines Agency, under the Falsified Medicines Directive, requires unique identifiers and tamper-evident features on prescription medicines to reduce risks of counterfeits. Japan’s Pharmaceuticals and Medical Devices Agency similarly issues structured guidance ensuring that packaging is legible, user-friendly, and clinically safe, he said.
India has already begun moving in this direction. Measures like mandating QR codes on select high-risk and high-value medicines under Schedule H2 have strengthened traceability and enabled easier authentication by pharmacists and consumers. By rethinking visual design, information hierarchy, and the prominence of safety-critical details, Indian manufacturers have an opportunity to make medicine packaging significantly easier and safer to use, said Chaudhary.
A more thoughtful approach to labelling and packaging reform can help strike this balance. Patient-centric design principles, such as high-contrast printing, intuitive layouts, and clear separation of critical information, can materially reduce the risk of medication errors. Tamper-evident systems and packaging designs that support error-free administration are especially important in hospital and critical-care environments, where multiple drugs are handled under time pressure. These improvements also help Indian manufacturers align more seamlessly with the expectations of global regulators and international buyers, said Chaudhary.
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