Drugs and Cosmetics Act

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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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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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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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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Double Check: Decoding India’s Dual Framework for Medical Device Labelling

Introduction

The medical devices sector in India is undergoing rapid transformation, driven by evolving regulations, technological advancements and growing healthcare demands. It is expected to grow to $20.51 billion by 2029. The demand for imported medical devices increased by 21% between November 2022 and October 2023, totalling medical device imports of INR 61,262.84 crore ($7.23 billion)[1]. The regulatory ambit governing medical devices in the country has seen significant reforms aimed at ensuring safety, quality and accessibility. For healthcare products, where precision and reliability are vital, stringent labelling regulations serve as a cornerstone for ensuring safety, quality, and consumer confidence. The regulatory framework for labelling of medical devices in India is governed by multiple legislative frameworks, each designed to uphold stringent standards.

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Navigating Adverse Drug Reactions: Extent of Pharmacovigilance in India

    Introduction

    Pharmacovigilance, as defined by the World Health Organization (WHO), is the science and practice of detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. Pharmacovigilance in essence aims to enhance patient safety by monitoring and evaluating the risks associated with pharmaceutical products. It is interesting to note that the significance of pharmacovigilance has grown over the years, especially with the increasing global integration of pharmaceutical supply chains and concerns over drug safety. With India being commonly referred to as the ‘pharmacy of the world’ due to it being a global supplier of affordable medicines, ensuring drug safety is critical for public health at large. This blog post outlines the pharmacovigilance system in India, including the existing framework, current challenges, and the future roadmap.

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    Prescription for Deception – An Analysis of Pharmaceutical Advertising in India

    Introduction

    Pharmaceutical advertisements hold significant power in shaping public perception of drugs, their efficacies and treatment options. In India, where healthcare access and awareness are often limited, misleading advertisements can have serious consequences. These ads have the potential to mislead customers and even endanger lives by exaggerating benefits or downplaying risks. Misleading advertisements, then, can simply be understood as uncorroborated, unsubstantiated, and often false claims made by pharmaceutical companies about their drugs – the lofty claims made by companies advertising their “COVID curing”[1] drugs to claims regarding “miracle drugs” that can battle life threatening diseases, are all case in point when one refers to misleading advertisements.

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    Impact of the Jan Vishwas Act, 2023 on the Pharmaceuticals Industry – Decriminalizing Minor Offences One Step at a Time

    Introduction

    The Jan Vishwas (Amendment of Provisions) Act, 2023 (“JV Act”) was introduced with the aim of conveying ease of doing business and to amend certain enactments for decriminalising and rationalising offences, thereby promoting trust-based governance. The impact of the JV Act has reverberated across various sectors, including the pharmaceuticals and cosmetics industry. A key area of interest in relation to the JV Act’s amendments is their impact on the Drugs and Cosmetics Act, 1940 (“D&C Act”), which governs the regulation of drugs and cosmetics in India.

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    Ayurvedic Medicine in Contemporary Times: Part 2 – Spicing Up Food Products

    Part 1  of our Ayurvedic Medicine in Contemporary Times series discussed the regulations and clinical evaluations governing Ayurvedic drugs and proprietary Ayurvedic medicines. The recent global resurgence of Ayurveda and a renewed interest in nutraceuticals and supplements derived from natural sources has led to an increased demand for biological resources. While this trend does lay emphasis on sustainable farming practices and effective resource management, not every natural product qualifies as an Ayurvedic product despite natural biological resources, such as plants, animal extracts, and minerals, being the primary building blocks of these Ayurvedic single-ingredient drugs or compound formulations.

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    Ayurvedic Medicine in Contemporary Times: Part 1 – Understanding Clinical Evaluation and Drug Development

    Introduction to Ayurveda

    Allopathic medicine, or modern Western medicine, has always played a dominant role in contemporary healthcare systems and is currently the mainstream practice. Nonetheless, Ayurveda – one of the oldest medical systems dating back thousands of years has stood the test of time, as its followers have reposed trust in its holistic healing properties for centuries. Ayurveda translates to “knowledge/science of life” in Sanskrit and emphasises the interconnectedness of the mind, body, and spirit for optimum health and wellness.

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