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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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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

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