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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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Innovative Medical Devices under the Lens of Clinical Investigations – A Dormant Volcano Waiting to Erupt?

Introduction

Since the advancements in healthcare services and medicinal sciences, medical devices in India have become part and parcel of the existing healthcare delivery services framework.  Medical devices, in essence, are tools, instruments and even software which inter alia enable healthcare service providers to diagnose, monitor, mitigate and treat illnesses and health conditions.Continue Reading Innovative Medical Devices under the Lens of Clinical Investigations – A Dormant Volcano Waiting to Erupt?

Encapsulating the Branded vs. Generics Debate: Pitfalls and Doctors’ Dilemma

The Ministry of Health and Family Welfare, on May 12, 2023, issued an Office Order directing heads of hospitals and polyclinics run by the Central Government, and CGHS wellness centres to ensure that all doctors (including residents) prescribe only generic medicines (“Order”). Additionally, this order contains an instruction to completely curtail the visits of medical representatives to hospital premises, with the caveat that information about new launches may be communicated by way of emails only.

On the face of it, there is little fault to be found in the Order and its dicta. In fact, it ties into the recent push to promote generic medications over expensive branded drugs. That said, it may be worthwhile to take a step back and look at the legal and policy implications of this course of action afresh, especially in light of the unintended consequences it may entail.Continue Reading Encapsulating the Branded vs. Generics Debate: Pitfalls and Doctors’ Dilemma

Introduction

In order to keep pace with the growing demand for quality goods and services while keeping competition at bay in this fiercely-contested sector, FMCG companies have constantly been on the lookout for effective and creative techniques to gain popularity and an edge over their rivals’ products. The marketing and sales teams of such companies, often armed with data, leave no stone unturned to outwit and outsell the products of competing companies. This comes as no surprise, as with the integration of innovative digital technologies and advancements in the possible venues for advertisements, companies have levelled up their consumer interaction experiences. For example, companies have now shifted their focus from hoardings and billboard advertisements to engaging social-media influencers to review and showcase their products. Some companies have even begun digitally interacting with customers and re-sharing posts (often with the company’s product prominently visible) of happy consumers on social media.Continue Reading What Does the Box Say? Exploring the legality of advertisement strategies commonly deployed by FMCG Companies

A Closer Look at India’s Pet Care Sector and Regulatory Grey Areas

In Part I of this series, titled ‘The (Pawsome) Pet Care Sector: Through a Legal Lens’, we provided a broad overview of the registration and compliance requirements for entities in the pet care industry. We also discussed factors like the entry options, the sector’s migration to the online mode, and relevant judicial pronouncements.

The legal framework for pet care in India is spread across a host of rules and legislations. The relevant regulatory duties are also divided between various regulators including the Food and Safety Standards Authority of India (“FSSAI”), the Central Drugs Standard Control Organisation (“CDSCO”), and the Animal Welfare Board of India, among others. Therefore, industry players will have to keep track of a wide range of legislations (along with relevant State rules and municipal laws) to ensure proper compliance.Continue Reading Barking up the Right Tree: A Closer Look at India’s Pet Care Sector and Regulatory Grey Areas

The pet-care sector has seen a massive growth in India, particularly during the pandemic. The sector is estimated to touch INR 10,000 crore by 2025[1], with the number of pets increasing at a rate of 11% per annum[2]. Healthcare services, nutrition, drugs, and pet-grooming form the core of the overall pet care sector.

Alongside growth, the pet care sector has witnessed a noticeable increase in competition with the entrance of several established as well as nascent players. Large organisations (like Emami) view investment in the pet-care sector as a favorable avenue for corporate diversification[3]. Owing to the specialised nature of the sector, the market trend appears to be one of strategic collaborations between large industry players and smaller organisations with niche focus areas. There are also collaborations between smaller organisations which aim to increase their reach and market share in the pet care sector – an example is the recent acquisition of Capt Zack (specializing in pet accessories) by Wiggles (specializing in pet food).Continue Reading The (Pawsome) Pet Care Sector: Legal Insights

Scrutinising India’s Organ Donation Laws and the Dilemmas of ‘Brain-Stem Death’

A significant demand-supply gap plagues the market for organ donation in India. The country has one of the lowest organ donation rates in the world, resulting in the death of innumerable patients in need of organ transplants.[1] While a part of this problem can be attributed to lack of awareness among potential donors, the issue is exacerbated by legislative ambiguity and regulatory shortcomings. The law on organ donation in India is primarily governed by the Transplantation of Human Organs and Tissues Act, 1994 (as amended in 2014) (“Act”), read with the Transplantation of Human Organs and Tissues Rules, 2014 (“Rules”).Continue Reading Beneath the Surface: Scrutinising India’s Organ Donation Laws and the Dilemmas of ‘Brain-Stem Death’

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

Introduction

There is no denying that India is one of the most significant players in the global pharmaceuticals space, especially in the generic and affordable vaccines segment. Emerging markets such as India are expected to become further crucial in the foreseeable future, given the global supply chain disruptions and discontinuities. Fifty percent of the global demand for various vaccines is met by the Indian pharmaceuticals industry and as per the Indian Economic Survey 2021, the domestic market is expected to grow 3x in the next decade. It is expected to develop at an annual rate of 11% over the next two years, possibly exceeding $60 billion in value.[1] India’s healthcare market is expected to reach $372 billion, driven by rising income, better health awareness and increasing access to insurance. India’s healthcare public expenditure stood at 2.1% of GDP in 2021-22 against 1.8% in 2020-21. Furthermore, in Union Budget 2022-23, Rs 86,200.65 crore ($11.28 billion) was allocated to the Ministry of Health and Family Welfare (MoHFW).Continue Reading Examining the Regulatory and Operational Issues Affecting M&A in Pharmaceuticals and Healthcare Industry

Digital Healthcare

The development in science and technology has scaled multiple heights and reached unprecedented levels of sophistication. Advanced methods are being used in all branches of research and technology, including medical diagnosis. Given that diagnosis is done either voluntarily or pursuant to a prescription, the field of medical testing is broad and encompasses a variety of situations. The process of diagnosis depends upon a range of variables, which includes diversified procedures, competent personnel, functional instruments, suitable facility or lab, reagent, etc. Each factor is as important as the other. Further, medical devices include a gamut of instruments ranging from a miniscule syringe used to collect blood samples, to sophisticated CT scanners. Both have the capacity to grossly impact a diagnosis. Hence, arises the need to minimise the variables and ensure uniformity in quality and standards. And, while the monitoring of medical devices, facilities and competent personnel are largely regulated, it is important to ensure that the diagnostic procedures are standardised.Continue Reading Evolving Landscape of Diagnostics’ Regulation in India & Digital Healthcare

Genetic Testing

Since the Covid-19 pandemic, people’s perception of healthcare has undergone a change. While the top 10 causes of death in India continue to be non-communicable diseases like diabetes, cardiac diseases, and respiratory diseases, these are easily preventable/ manageable if addressed at an early stage through vital screening and consultation at regular intervals. Furthermore, routine testing might reduce the severity of rare disorders, including auto-immune deficiencies, and also help lower cancer-induced mortality.Continue Reading Genetic Testing: A new doorway towards opportunities, challenges in preventive healthcare