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

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.Continue Reading Navigating Adverse Drug Reactions: Extent of Pharmacovigilance in India

    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.Continue Reading Prescription for Deception – An Analysis of Pharmaceutical Advertising in India

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

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

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

    Regulating Software as Medical Devices – Navigating Hurdles One Byte at a Time

    Transitioning Regulatory Landscape

    Dynamic progress in healthtech and medtech has led to a transformative surge of the medical devices landscape, propelling the rise of new and innovative medical devices. However,  preceding the amendments to the Medical Devices Rules, 2017 (“MD Rules”), only a handful of medical devices were regulated, with software escaping regulatory scrutiny. Recognising the myriad instruments affecting individual and animal health, the Government found it imperative to extend regulations to this rapidly evolving realm. Continue Reading Regulating Software as Medical Devices – Navigating Hurdles One Byte at a Time

    Linking Patents to Pills: Unravelling the Patent Linkage Framework for Pharmaceutical Products in India

    A patent grants the patentee exclusive rights, title, and interest in an invention. This creates a right in rem – a right to restrict a third party from making, using, offering for sale, selling, or in any manner commercializing the invention (as claimed in the patent)[1] for a period of 20 years[2]. In case of drugs, grant of patent, does not give the patent owner an automatic right to market the product. Such additional right in the form of a marketing approval/ license/ registration is granted by the concerned drug regulatory body acting under the auspices of the relevant legislation that regulates the import/ manufacture/ sale/ marketing of the drug in the relevant jurisdiction. Continue Reading Linking Patents to Pills: Unravelling the Patent Linkage Framework for Pharmaceutical Products in India

    Medical Devices Policy, 2023

                                                                                                                                                   

    In a bid to reduce import dependency and boost domestic production of medical devices, the Union Cabinet recently approved the National Medical Devices Policy, 2023 (“Policy”)[1]. The broad contours of the Policy were earlier notified vide a press release issued by the Press Information Bureau (“Press Release”).[2] The Policy aims to reduce India’s import reliance and has a stated goal to establish India as a global manufacturing hub for medical devices. This announcement comes at a time when the Government is actively promoting the ‘Atmanirbhar Bharat’ and ‘Make in India’ initiatives.Continue Reading Medical Devices Policy, 2023 – A Vision to Streamline Regulation, Incentivise Domestic Manufacturing and Facilitate R&D

    Cosmetics Regulation in India

    Customised cosmetics have recently grown in popularity, with customers increasingly appreciating the value of personalised rather than off-the-shelf products. Customers often prefer to pick ingredients which suit their skin/ hair characteristics, and associate such unique products with greater effectiveness and functionality. Several cosmetics manufacturers and retailers are already in the race to capture this growing demand in India. However, little attention has been paid to the legal implications and regulatory risks which arise from the import, production, storage, mixing and/ or retail of such customised cosmetics. It is therefore essential for players in this emerging market to be mindful of certain important legal questions and considerations to ensure proper compliance. This is especially in light of the new regulatory landscape, which has been laid down through the Cosmetics Rules, 2020 (“Cosmetics Rules” / “Rules”) and has been rapidly evolving over the past few years.Continue Reading Concept to Compliance: Unveiling the Untapped Realm of Customised Cosmetics Regulation in India