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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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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

Mind Your Meds and Metrics: Navigating the Indian Health Data Protection Labyrinth

Introduction

India’s private healthcare entities are increasingly participating in government initiatives, in a sector historically dominated by private players. This synergy is evident in public-private partnerships like the Ayushman Bharat National Health Protection Mission and the Pradhan Mantri Jan Arogya Yojana. The aim of the programmes is to expand healthcare access and affordability, reflecting a significant policy shift towards inclusive health coverage.Continue Reading Mind Your Meds and Metrics: Navigating the Indian Health Data Protection Labyrinth

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

Rx for Referrals: Navigating the Ethical Considerations in India’s Medical Landscape

Introduction

In the intricate ecosystem of global healthcare, the trust between doctors and patients forms the bedrock of ethical practice. A growing number of Indian healthcare service providers are integrating digital health technologies into their business development initiatives and operational framework, leading to an unsettling trend. Several such healthcare providers now deploy offline and online resources to set up and maintain incentive-driven patient referral networks through collaboration and partnership arrangements with healthcare institutions and practicing doctors. These arrangements are designed to attract new patients through referrals from doctors, pharmacists, and healthcare workers, who are then adequately compensated with merchandise, coupons, gifts, travel facilities and grants. This intersection of medicine and commerce raises profound ethical and legal questions, challenging the integrity of the medical profession and the sanctity of patient care.Continue Reading Rx for Referrals: Navigating the Ethical Considerations in India’s Medical Landscape

Pre-Clinical Testing on Claws and Paws: Decoding the Permissibility of Animal Experimentation

Introduction

The practice of experimenting on animals has long been a focal point of ethical and regulatory debates. Juxtaposed against the concerns for animal welfare, this complex landscape tries to strike a balance between the pursuit of scientific progress to advance human knowledge and safeguard the rights and well-being of fellow planet inhabitants. Notwithstanding the surge in global commitment to reduce the number of animals used in experimentation and research activities, reports indicate that more than 100 million animals are used globally for experimentation on an annual basis. Further, trend suggests that, currently, there is little to no decline in worldwide use of animals in research and lab work.Continue Reading Pre-Clinical Testing on Claws and Paws: Decoding the Permissibility of Animal Experimentation

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