Photo of Priyam Rajkumar

Senior Associate in the Pharmaceutical, Life-sciences and Healthcare practice at the Delhi NCR office of Cyril Amarchand Mangaldas. Priyam graduated from the University of Edinburgh, United Kingdom in 2019 and completed his Bridge Course from the National Law University, Delhi in 2020 and specializes in regulatory compliance, advisory work, tender matters and litigation pertaining to the pharmaceutical, medical devices, digital health, clinical trials and the life-sciences industry. He also has prior experience in technology, media and telecommunications (TMT) advisory, education matters and labour and employment matters. He can be reached at priyam.rajkumar@cyrilshroff.com

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

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

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?

The National Medical Devices Policy, 2023: A Closer Look at Strategy and Implementation

In an earlier blog post, we took a close look at the National Medical Devices Policy, 2023 (“Policy”), notified by the Department of Pharmaceuticals (“DoP”) on May 2, 2023[1]. We delved into the framework, objectives and core focus areas of the Policy. While the aim of the Policy was clearly to reduce import dependency and establish India as a global manufacturing hub for medical devices, little information was provided on the means to achieve these goals. To draw a holistic picture, we sought guidance from the Approach Paper to the National Medical Devices Policy, 2022 (“Approach Paper”)[2], which was based on similar principles and furthered the same goals as the present Policy. However, the DoP has recently also issued a strategy document on the Policy (“Strategy Document”)[3] to fine-tune and expand on its implementation strategies. In light of the same, this blog post analyses the Strategy Document, measures envisaged thereunder, enforcement priorities and focal points.Continue Reading The National Medical Devices Policy, 2023: A Closer Look at Strategy and Implementation