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Biplab Lenin

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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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CRISPR, The New Gold Standard?Understanding The Rise Of Genetic Engineering In India – Part 2

In Part 1 of the CRISPR blogpost series, we outlined the science behind CRISPR technology and also illustrated its current and potential uses in India. As previously discussed, CRISPR technology, being a genetic engineering method, poses some serious concerns. These concerns are largely ethical, social, and safety related. Hence, it is pertinent to understand the regulatory regime for CRISPR in India. In this blog post, we have outlined the regulatory regime for genetic engineering in India, with special focus on CRISPR technology.Continue Reading CRISPR, The New Gold Standard?Understanding The Rise Of Genetic Engineering In India – Part 2

CRISPR, The New Gold Standard? Understanding The Rise Of Genetic Enigineering In India – Part 1

Introduction

Advancements in science and technology have made gene-editing and the creation of genetically modified organisms (“GMOs”) a reality. It is now possible to alter and modify the genetic makeup of living organisms, leading to breakthroughs in agriculture and medicine. Such technologies and practices are being widely adopted across the world, including India, where gene editing is being explored primarily in agriculture to develop climate-resistant crops such as BT Cotton, BT Brinjal, GM-Mustard, etc. The global genome editing market, valued at $3.41 billion in 2024, is projected to reach $4.25 billion in 2025 and $13.36 billion by 2035, representing a CAGR of 12.1% during the forecast period[1].Continue Reading CRISPR, The New Gold Standard? Understanding The Rise Of Genetic Engineering In India – Part 1

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

    Introduction

    In this age of fast-paced routines riddled with stress and anxiety, the increasing and much-needed focus on health and lifestyle has led to the greater consumption of immunity-boosting and lifestyle-enhancing health products. These products are easily accessible and are not medicines or drugs that come with their fair share of risks, fueling a rising attraction towards nutraceutical products. Continue Reading Cure or Supplement – Overlap Between Drugs and Nutraceuticals

    Advertisements of Illusions: A Look into Advertising Practices of Clinical Establishments in India

    Introduction

    While “health is wealth” is a popular adage, some might suggest that clinical establishments like corporate hospitals and private clinics have taken it too literally by commercialising and monetising healthcare and related services. The question that remains is whether the means of promoting and publicising the establishments’ offerings are unfair and mislead consumers and the public at large. Statistics presented by the Advertising Standards Council of India (“ASCI”)[1], the only dedicated watchdog for advertising practices of companies in India, suggests that a big chunk of complaints regarding misleading advertisements is related to the health sector. To put things into perspective, ASCI reported 190 instances of misleading advertisements by clinics and hospitals – from lofty claims about their services, promises of curing chronic conditions, inadequate disclosure of actual costs of the services, etc., hospitals and clinical establishments have time and again appeared on the radar of advertisement regulatory authorities.Continue Reading Advertisements of Illusions: A Look into Advertising Practices of Clinical Establishments 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

    Beyond the Basket: Inside India’s Diverse E-Commerce Food Landscape – Part 2

    Introduction

    In our previous blog post, we provided insights into the regulatory framework governing E-Commerce Food Business Operators (“E-FBOs”)[1] that operate under the purview of the Food Safety and Standards Authority of India (“FSSAI”). The FSSAI, along with its state counterparts, is primarily empowered under the Food Safety and Standards Act, 2006 (“FSS Act”) and its accompanying rules, regulations, and guidelines to regulate the food industry and establish standards that ensure the safety and quality of food products. We also delved into the recent amendment to the FSS Licensing and Registration of Food Businesses Amendment Regulations, 2021 (“2021 Amendment Regulations”)[2], which were primarily introduced to regulate E-FBOs. We also analysed it in line with the key challenges and obstacles that E-FBOs might encounter, on their road to ensuring full compliance with the regulations.Continue Reading Beyond the Basket: Inside India’s Diverse E-Commerce Food Landscape – Part 2

    Beyond the Basket: Analysing Underlying Challenges for India’s E-FBOs – Part 1

    Introduction

    India’s food industry is experiencing a digital revolution, with E-Commerce Food Business Operators[1] (“E-FBOs”) transforming the way food and related services/ products are being ordered, consumed and experienced. From local restaurants and cafes offering delivery through mobile applications, cloud kitchens serving gourmet meals, groceries delivered within minutes, the E-FBO landscape is brimming with innovation and opportunity. However, this digital transformation is not without regulatory challenges that E-FBOs must navigate to ensure compliance and maintain consumer trust.Continue Reading Beyond the Basket: Analysing Underlying Challenges for India’s E-FBOs – Part 1

    From Farm to Fork: Demystifying India’s Food Safety Standards

    Introduction

    The Indian food industry thrives on innovation and dynamism, hence ensuring the safety of food products remains a top priority for the Indian authorities. The Food Safety and Standards Authority of India (“FSSAI”) serves as the guardian of public health, that introduced the Food Safety and Standards Act, 2006 (“FSS Act”). This legislation read with its compendium of regulations, rules, and guidelines meticulously outlines the framework for every step of the food supply chain from its origin to your table. While the FSS Act provides a foundational framework, the nuances of the regulatory framework are recorded in the regulations and guidelines, which have been established over time to encompass and regulate the expansive and ever-changing world of food products. This blog post delves into the legalities that govern the key aspects of the food industry; namely, production, distribution, import, advertising, labelling, and the safety testing standards.Continue Reading From Farm to Fork: Demystifying India’s Food Safety Standards