Fitness Wearables and the Law: Part 2
By Shantanu Mukherjee and Anushka Iyer RECAP OF PART 1 The use of wearable devices capable of identifying key human biomarkers (e.g. blood pressure and oxygen levels) sharply accelerated during the Covid-19 pandemic. The deadly coronavirus came as an unpleasant reminder of the human body’s frailty and triggered a desire among many to lead healthier […]
Is Your Watch FDA Approved? Fitness Wearables and the Law: Part 1
by Shantanu Mukherjee and Anushka Iyer* on May 20, 2022 INTRODUCTION The COVID-19 pandemic led to the evolution and adoption of technology at an unprecedented pace in the Lifesciences industry, to the point where much of what would have been considered science fiction a few years ago is now close to reality. Consider how the […]
The Regulation of Telemedicine: A Global Comparative Analysis
by Shantanu Mukherjee and Vatsala Sood[i] INTRODUCTION Telemedicine usage spiked early in the COVID-19 Pandemic as consumers and providers sought safe ways to access and deliver healthcare. The healthcare profession had to react swiftly to deal with the social distancing measures put in place to assist flatten the curve of COVID-19 infections. At the peak […]
An Overview of Healthtech Regulation in India: Part 2
RECAP OF PART 1 The pandemic has catalysed an unprecedented degree of interest in digital health and ‘healthtech’, in terms of products and services being offered, patient/consumer adoption and investor appetite. Yet, predictably, legislation has failed to keep up with the breakneck pace of growth in this young industry. For now, the healthtech ecosystem is […]
An Overview of Healthtech Regulation in India: Part 1
INTRODUCTION The Covid-19 pandemic exacted a brutal toll in two seemingly interminable years, between 2020 and 2021, and continues to affect lives, livelihood and economic damage. Those who have been infected (a number that likely accounts for a majority of our population at this point) and survived continue to struggle with lingering, sometimes inexplicable symptoms, […]
Oxygen and the Pandemic: FAQs for Corporates
India’s oxygen needs shot up exponentially (over 10x) during the second wave of the Covid-19 pandemic in April 2021, mandating significant changes in the regulation of manufacture, import and distribution of medical oxygen. Consequently, notifications were issued by various departments of the Government around its production, supply, import, usage, taxation and pricing. Industrial usage of […]
The Politics of President Biden’s Support for the TRIPS Waiver Proposal
To anyone familiar with the global pharmaceutical industry’s considerable political influence, President Joe Biden’s announcement on May 5, 2021, that the US intended to support the TRIPS waiver proposal, must have seemed like a startling change of tune. President Biden’s statement was followed by a similarly unexpected statement from the European Commission (EU)’s head the […]
Corporate Vaccination Camps: FAQs for Employers
INTRODUCTION When the Government of India (GoI) first launched its Covid-19 vaccination program on 16 January 2021, only the GoI could procure and distribute vaccines. The Ministry of Health and Family Welfare (“MoHFW”) had already issued its ‘Covid-19 Operational Guidelines’ on 28 December 2020, outlining the GoI’s vaccination strategy and related guidelines. The guidelines did […]
A Jab of Indemnity
“I’d like my free market pricing with a side of sovereign indemnity, please.” Should vaccine manufacturers be indemnified by the Indian Government against serious adverse reactions arising from their vaccines? This is the latest slithering twist in the high-stakes game of snakes and ladders that is India’s vaccination programme. It started with reports in mid-May […]
How the Vax was Won | Part 2: Follow the Money
RECAP OF PART 1 (IDEALS v. DEALS) Critics of the monopoly-based ideology underpinning the modern global intellectual property (IP) regime believe it is not geared towards equity, and as a result, poorer countries are being denied access to Covid-19 vaccines and drugs, in a repeat of what happened in the AIDS and Ebola epidemics. Countries […]
