Pharmaceuticals

When The Cover Gets Judged: Unboxing Cosmetics Packaging Obligations

Summary: Cosmetics packaging sits across overlapping regimes, spanning labelling accuracy, plastic waste management, and product-specific rules of their own. A single product may touch all three frameworks at once, raising issues from registration requirements to mislabelling liability to repercussions for missed EPR targets. The real challenge, however, lies in reliably seeing where they all converge on the same pack.

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Patchwork of Legal Classification: How Transdermal Patches reveal the fault lines in India’s Drug–Cosmetic Divide

Summary: This article explores the regulatory challenges surrounding acne and transdermal patches in India. An acne patch that promises to “reduce a blemish overnight” and a nicotine patch that delivers a measured dose through the skin look worlds apart. Yet under Indian law, both sit on the same unresolved line. Their classification determines whether a company needs only a cosmetic registration or a full drug license backed by clinical data, with any misclassification carrying serious risks.

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Building the Missing Middle Piece: The Case for Micro-Hospitals in India

Summary: India’s healthcare delivery has long been shaped by two extremes: small clinics offering basic consultation and large corporate hospitals delivering advanced tertiary care. Micro-hospitals, typically comprising 15 to 75 beds, have emerged as the “missing middle”, combining lean infrastructure, digital diagnostics, and a sharper focus on patient experience. This blog examines the rationale for the micro-hospital model, its operational and economic advantages, and the extensive regulatory framework that governs hospital establishments of any size in India today.

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Breathing Life into Regulation: Case for ECMO Governance in India

Summary: Despite Extracorporeal Membrane Oxygenation (“ECMO”) gaining significance as part of critical care treatment in India, especially post-COVID-19, the regulations for ECMO treatment continue to be restricted to the Medical Devices Rules, 2017, and the device risk classification guidelines of the Central Drugs Standard Control Organization. This blog discusses the evolving regulatory regime in relation to ECMO in India, the lack of specific clinical governance protocols for ECMO treatment, and the need for such a protocol.

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Beyond The Siren: Rethinking The Role of Modern Ambulances

Summary: This article examines whether advanced ambulances, such as ALS vehicles and Mobile ICUs, could be classified as mobile clinics or Mobile Medical Units, attracting registration requirements as ‘clinical establishments’ under the Clinical Establishments Act, 2010. A review of the applicable regulatory framework indicates that ambulances and MMU/ mobile clinics serve fundamentally distinct purposes and are regulated differently, with ambulances presently not requiring clinical establishment registration solely by virtue of carrying medical equipment. However, as pre-hospital care continues to evolve, there is a growing need for a clearer regulatory framework to address the increasingly blurred boundaries between emergency transport vehicles and mobile healthcare delivery.

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From Awareness to Advertising: Re-examining the GLP-1 drug boundaries (Part 1)

Summary: Part 1 of this Article examines the CDSCO’s March 2026 Advisory directed at manufacturers, importers and marketing authorisation holders of GLP-1 receptor agonists, reinforcing that regulatory scrutiny of prescription-only medicine promotion will focus on substance over form. It prohibits all advertising — whether direct, surrogate, or influencer-led — that create brand recall among public.

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Summary:India’s sexual wellness industry operates under a regulatory paradox wherein products are permitted to be legally sold, but advertising is restricted. This situation arises due to outdated obscenity laws, inconsistent enforcement, restrictive platform policies, and the lack of a dedicated regulatory framework, despite judicial progress and confirmation that such products are not classified as medical devices.

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Claims, Compliance and Credibility: Changing Face of Food Regulation in India

Summary: India’s food regulations have evolved from focusing mainly on hygiene to closely monitoring advertising and health claims. In recent years, enforcement has shifted toward demanding stronger scientific evidence and India‑specific validation to back up product claims. While this may slow down approvals, it rewards businesses that invest in credible research, giving them a competitive edge over those relying only on marketing.

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The Cosmos of Cosmeceuticals in India

Summary: Cosmeceuticals are topical products with biologically active ingredients that blur the line between cosmetics and pharmaceuticals. Such products have gained significant market traction in India, yet occupy a regulatory grey zone with no independent legal status under the Drugs and Cosmetics Act, 1940. This ambiguity forces businesses to strategically navigate compliance by carefully crafting product claims to remain within the “cosmetic” category while avoiding the stricter regulatory requirements applicable to “drugs” or “medical devices”.

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Medical Device As Software: Has CDSCO Guidance Changed The Rules?

Summary: The CDSCO’s Draft Guidance on Medical Device Software only clarifies how the existing Medical Devices Rules apply to software across its lifecycle, but does not create any new regulatory requirements. Its significance lies in signalling a more structured, risk-based and lifecycle-oriented approach to regulating software-driven healthcare products in India.

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