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Biplab Lenin

Partner in the Pharmaceutical, Healthcare & Life Sciences Practice at the Delhi NCR office of Cyril Amarchand Mangaldas. Biplab is an alumnus of IIT Kharagpur Law School. He is also an Industrial Biotech Engineer and a registered patent agent. Biplab specializes in regulatory, transactions, advisory and disputes pertaining to drugs, medical devices, healthcare, food, biotechnology, intellectual property matters including patents, plant variety and biodiversity. He can be reached at biplab.lenin@cyrilshroff.com

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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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Mirror, Mirror on the Wall: The Rise of Personalised Cosmetics Regimens in India

Summary: With artificial intelligence increasingly driving the personalisation of skincare and beauty products in India, businesses operating at this intersection must navigate a complex and evolving regulatory landscape. This post examines the key legal considerations that arise when AI is used to design customised cosmetic regimens. It explores the classification risk where AI-driven analysis and tailored recommendations risk crossing the line from cosmetics into drugs or even software as a medical device. It then considers the interplay between product and service liability under the Consumer Protection Act, 2019, particularly where harm results not from a defective product per se, but from an AI algorithm’s failure to account for individual user characteristics.

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Summary: Whole genome sequencing has rapidly transitioned from a research tool to a routine diagnostic offering in India, now available through accredited laboratory chains and direct-to-consumer testing kits alike. Yet India lacks a single, dedicated law governing genomic testing; instead, existing frameworks for laboratory accreditation, clinical establishments, and medical devices reach WGS only incidentally, leaving significant gaps around informed consent, genetic counselling, and long-term data protection. A comparative look at the United Kingdom and the United States reveals more structured, albeit still evolving, approaches to regulating genetic diagnostics and consumer genomics. This blog examines the current Indian regulatory patchwork and makes the case for a purpose-built governance framework that addresses the unique, far-reaching implications of genomic information.

Continue Reading Decoding the Genome, Encoding the Law: Whole Genome Sequencing in Healthcare
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.

Continue Reading Patchwork of Legal Classification: How Transdermal Patches reveal the fault lines in India’s Drug–Cosmetic Divide
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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Beyond the Advisory - The Legal Framework Governing GLP-1 Drug Advertising

Summary: This article examines the reach of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, through the lens of key judicial pronouncements – from the Supreme Court’s ruling in Hamdard Dawakhana upholding the constitutionality of advertising restrictions to the Bombay High Court’s broad reading of Section 4 as a catch-all prohibition against misleading drug advertisements and the Supreme Court’s recent observations in the Patanjali matter. These rulings map the boundaries of what constitutes a prohibited advertisement and identify the penal consequences under the Drugs and Cosmetics Act, 1940 Act and the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, for non-compliance with the Advisory.

Continue Reading Beyond the Advisory – The Legal Framework Governing GLP-1 Drug Advertising (Part 2)
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.

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

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.

Continue Reading India’s sexual wellness industry caught between prohibition, perception and profit