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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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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”.Continue Reading The Cosmos of Cosmeceuticals in India

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Summary: The CDSCO’s Draft Guidance on Medical Device Software only clarifies how the existing Medical Devices Rules apply to software across its lifecycle, but does not create any new regulatory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.Continue Reading Medical Device As Software: Has CDSCO Guidance Changed The Rules?

Curbing Hospital and Surgeon Promotions in India: Regulation of Live Surgery Broadcasts

Summary: The NMC has issued new guidelines restricting live surgery broadcasts to curb patient exploitation, ensure ethical safeguards, and prevent commercial misuse. The framework shifts focus towards pre-recorded simulations and controlled teaching environments to balance education with patient rights.Continue Reading Curbing Hospital and Surgeon Promotions in India: Regulation of Live Surgery Broadcasts

In Part 1 of the blog post series, we explored the complex and multi-layered regulatory framework governing alcohol advertising and packaging in India. We discussed how both central and state laws — shaped by constitutional mandates, statutory provisions, and evolving self-regulatory guidelines — intersect to create a challenging compliance landscape. As we highlighted, the rise of surrogate advertising and the tightening grip of regulators have significantly reshaped industry practices. In this second part, we turn our focus to the fast-evolving regulatory environment specific to digital media, packaging and labelling norms, and the divergent approaches adopted by Indian states. As online platforms become increasingly central to brand communication and consumer engagement, and as product labelling becomes a site of regulatory scrutiny, it is essential to unpack the distinct legal developments shaping the alcohol industry’s future in India.Continue Reading Pouring Over the Law: Navigating Alcohol Advertising & Packaging Regulations in India – Part 2

Pouring Over the Law: Navigating Alcohol Advertising & Packaging Regulations in India – Part 1

CAM Comment: Part 1 of this blog post series aims to shed light on the multi-layered regulatory framework surrounding the advertisement and promotion of alcoholic beverages in India.

Introduction

India presents a uniquely complex regulatory environment for the alcoholic beverages industry. Unlike many sectors governed primarily by central legislation, alcohol falls under the purview of states, creating a fragmented landscape of laws governing production, sale, advertising, and consumption. This complexity stems from the Indian Constitution, which places production,  possession, transport, purchase and sale of intoxicating liquors on the State List, granting states legislative power. This contrasts with the Directive Principle in Article 47, which encourages states to prohibit intoxicating drinks, highlighting an intrinsic conflict between public health objectives and the significant state revenue generated from alcohol excise duties.Continue Reading Pouring Over the Law: Navigating Alcohol Advertising & Packaging Regulations in India – Part 1

Understanding regulatory safeguards for influencer marketing of nutraceuticals in India

Introduction

The last decade witnessed an increasing number of nutraceuticals — in the form of teas, protein powders, or hair-growth gummies — being marketed by influencers and celebrities on social media platforms. The Indian nutraceutical market is experiencing significant growth, mirrored by the meteoric rise in influencer marketing as a potent channel to reach health-conscious consumers. Reports suggest that the Indian nutraceutical market is projected to touch $10.19 billion by 2026. While collaborations between nutraceutical brands and social media influencers offer compelling opportunities for engagement and sales, this intersection operates within a complex and strictly regulated legal environment. Navigating this landscape requires adherence to a multi-layered framework, encompassing inter alia the regulations laid down by the Food Safety and Standards Authority of India (“FSSAI”), the code set out by Advertising Standards Council of India (“ASCI”), and the Consumer Protection Act, 2019 (“CP Act”). In this article, we outline the key regulatory considerations and underscore the necessity of ensuring compliant nutraceutical marketing campaigns in India.Continue Reading Understanding regulatory safeguards for influencer marketing of nutraceuticals in India

Paneer or Not Really Paneer? Navigating the Regulatory Landscape of Dairy Analogues in India

Introduction

In the Indian culinary landscape, for a substantial segment of the population, particularly those adhering to vegetarian diets, paneer serves not merely as a delicacy but as a vital source of protein and essential nutrients, effectively stepping in where non-vegetarian options might otherwise feature. From rich curries to flavourful stir-fries, delectable snacks and desserts, Indians consume paneer in different forms. However, recent concerns regarding proliferation of ‘fake’ paneer in the market have created doubts and apprehensions in the minds of Indian consumers.Continue Reading Paneer or Not Really Paneer? Navigating the Regulatory Landscape of Dairy Analogues in India

Tobacco Control Laws in India: Ambit of restrictions on consumption, advertisements and packaging of cigarettes

Introduction

The consumption of tobacco products continues to be a major public health issue in India, with smoking-related diseases causing numerous deaths annually. According to estimates cited in the World Health Organization’s (“WHO”) ‘Economic Costs of Diseases and Deaths Attributable to Tobacco Use in India’ study, “the economic burden of diseases and premature deaths attributable to smoking and smokeless tobacco use by persons over 35 years of age in India is over 1% of India’s GDP”. Further, the expenditure incurred to treat tobacco related illnesses and diseases accounts for 5.3% of the total private and public health spending in India in a year[1]. Continue Reading Tobacco Control Laws in India: Ambit of restrictions on consumption, advertisements and packaging of cigarettes

Designer Babies in India: Ethical Dilemma and Legal Roadblocks

Introduction

Imagine walking into a fertility clinic and choosing every detail of your future baby, including eye colour, height, intelligence, athletic ability, and even resistance to genetic diseases. Advancements in reproductive technology are pushing the boundaries of what is possible. In the United States, the demand for sperm and egg selection is soaring, with individuals spending thousands of dollars to “curate” their ideal baby. However, it is important to note that experts in the United States currently do not support the practice of creating designer babies through gene editing. Continue Reading Designer Babies in India: Ethical Dilemma and Legal Roadblocks