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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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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

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

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’