Summary: The CDSCO’s Draft Guidance on Medical Device Software only clarifies how the existing Medical Devices Rules apply to software across its lifecycle, but does not create any new regulatory requirements. Its significance lies in signalling a more structured, risk-based and lifecycle-oriented approach to regulating software-driven healthcare products in India.Continue Reading Medical Device As Software: Has CDSCO Guidance Changed The Rules?
The last decade witnessed an increasing number of nutraceuticals — in the form of teas, protein powders, or hair-growth gummies — being marketed by influencers and celebrities on social media platforms. The Indian nutraceutical market is experiencing significant growth, mirrored by the meteoric rise in influencer marketing as a potent channel to reach health-conscious consumers. Reports suggest that the Indian nutraceutical market is projected to touch $10.19 billion by 2026. While collaborations between nutraceutical brands and social media influencers offer compelling opportunities for engagement and sales, this intersection operates within a complex and strictly regulated legal environment. Navigating this landscape requires adherence to a multi-layered framework, encompassing inter alia the regulations laid down by the Food Safety and Standards Authority of India (“FSSAI”), the code set out by Advertising Standards Council of India (“ASCI”), and the Consumer Protection Act, 2019 (“CP Act”). In this article, we outline the key regulatory considerations and underscore the necessity of ensuring compliant nutraceutical marketing campaigns in India.Continue Reading Understanding regulatory safeguards for influencer marketing of nutraceuticals in India
Imagine walking into a fertility clinic and choosing every detail of your future baby, including eye colour, height, intelligence, athletic ability, and even resistance to genetic diseases. Advancements in reproductive technology are pushing the boundaries of what is possible. In the United States, the demand for sperm and egg selection is soaring, with individuals spending thousands of dollars to “curate” their ideal baby. However, it is important to note that experts in the United States currently do not support the practice of creating designer babies through gene editing. Continue Reading Designer Babies in India: Ethical Dilemma and Legal Roadblocks
Advancements in science and technology have made gene-editing and the creation of genetically modified organisms (“GMOs”) a reality. It is now possible to alter and modify the genetic makeup of living organisms, leading to breakthroughs in agriculture and medicine. Such technologies and practices are being widely adopted across the world, including India, where gene editing is being explored primarily in agriculture to develop climate-resistant crops such as BT Cotton, BT Brinjal, GM-Mustard, etc. The global genome editing market, valued at $3.41 billion in 2024, is projected to reach $4.25 billion in 2025 and $13.36 billion by 2035, representing a CAGR of 12.1% during the forecast period[1].Continue Reading CRISPR, The New Gold Standard? Understanding The Rise Of Genetic Engineering In India – Part 1
In this age of fast-paced routines riddled with stress and anxiety, the increasing and much-needed focus on health and lifestyle has led to the greater consumption of immunity-boosting and lifestyle-enhancing health products. These products are easily accessible and are not medicines or drugs that come with their fair share of risks, fueling a rising attraction towards nutraceutical products. Continue Reading Cure or Supplement – Overlap Between Drugs and Nutraceuticals
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
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
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
In a recent case[1], Novartis AG[2] v. Natco Pharma Ltd.[3], the Division Bench (DB) of the Delhi High Court (DHC) adjudicated on the extent of engagement a pre-grant opponent should be allowed under the Patents Act, 1970, in the course of proceedings initiated by the Controller, requiring the patent applicant to amend or modify the patent application.Continue Reading DB of DHC sets the contours of Pre-grant opponent in an examination process
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