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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

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

Pharmaceutical and Healthcare

Since the inception of the ‘world wide web’, no other technology in the digital space has caught the attention of the world quite like ‘blockchain’. It has the potential to be a gamechanger with its promise of unmatched data security. Even though the implementation/ application of blockchain’s much-coveted underlying technology into various other industries has been a very recent phenomenon, the learned are already prophesising about  its ability  to shepherd us into a completely new way of network interactions and data storage. This future reality has been nick-named  ‘Web3’.Continue Reading Pharmaceutical and Healthcare Industry: A Case for Regulation Through Blockchain

Consent in Healthcare

In Part 1 of this series (Consent in Healthcare: Outline, Gaps and Conundrum), we presented a brief regulatory background on informed consent in healthcare in India, as well as judicial pronouncements on the topic. We also focussed on specific methods of obtaining consent as prescribed by such regulations.

In this section, we’ll look at the practical implications of such legislations and rulings, particularly in the context of telemedicine and digital health, as well as instances in which the patient is unable to provide consent.Continue Reading Consent in Healthcare: Outline, Gaps and Conundrum (Part 2)

Consent in Healthcare

Informed consent is the bedrock of ethical medical practice. It is when a medical practitioner explains a medical treatment, irrespective of whether it is simple, sophisticated, fundamental, or specific, to a patient, before the patient agrees to it. It is crucial from a liability perspective as well. The Delhi High Court, in a recent order[1], noted with concern the absence of informed consent taken from a patient who underwent a hair transplant, which resulted in complications, leading to death of the said patient. The Court pointed out that hair transplantation, being an aesthetic surgery, needs to be performed by qualified dermatologists or trained surgeons with informed consent of the patient. While this matter relates to the limited aspect of informed consent in a cosmetic surgery setting, the issues raised in the case may have broader implications.Continue Reading Consent in Healthcare: Outline, Gaps and Conundrum (Part 1)

In Search of a Vaccine for Covid-19 - A Race to The Finish

The Covid-19 pandemic has wreaked havoc on mankind, infecting well over 13 million, and claiming over half a million lives. It has also severely impacted economies across the world. Our healthcare infrastructure has been pushed to its limits and our frontline healthcare professionals are working to the brink of exhaustion, risking their own lives to save others. We bow to them.

In the midst of all this, scientists across the world are working feverishly to find a vaccine for this disease. The hopes of billions rest on this. The World Health Organization (“WHO”) has (as of July 15, 2020) declared that there are about 23 potential vaccine candidates that are currently in various stages of clinical trials[1]. Out of these 23 vaccines, vaccines being developed by: (a) Sinovac (inactivated +alum); and (b) University of Oxford / AstraZeneca has entered into the Phase-III of its clinical trials[2]. In addition, as of July 15, 2020, there are around 140 vaccine candidates in preclinical evaluation (trials not commenced).
Continue Reading In Search of a Vaccine for Covid-19: A Race to The Finish