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Home Posts tagged "healthtech"

The digital accessibility of technology platforms

By Ikigai Law | Health-tech | 0 comment | 17 October, 2022 | 2

Health-tech platform Practo has been directed to make their website and apps accessible for persons with disabilities. This has wide-ranging implications for digital platforms. Enhancing digital accessibility is not a new conversation. Change.org petitions seeking accessibility improvements in the digital platforms of various companies are inviting attention. Swiggy and Zomato reportedly made their platforms accessibleRead more

The regulatory highs and lows of launching medicinal hemp products

By Ikigai Law | Health-tech | 0 comment | 19 July, 2022 | 2

In this post, we unpack the regulatory compliances a medicinal hemp product has to go through.  Introduction  In our last posti we spoke about the history, science and the regulator’s take on cannabis. In this installment on cannabis regulation, we tell you how you can cultivate, sell and market your hemp products.   Largely, hemp canRead more

Project Reg-AIH: British High Commission and Ikigai’s project to drive conversations on AI in healthcare in India and UK

By Ikigai Law | Health-tech | 0 comment | 13 May, 2022 | 1

This post captures the key takeaways from the British High Commission – Ikigai programme on ‘building bridges on regulatory approaches to artificial intelligence/ machine learning (AI/ML) enabled health tech’. Background: India and the United Kingdom (UK) are pursuing a common vision for strategic partnership through an ambitious India-UK Roadmap to 2030. A key pillar ofRead more

Hemp gets recognition as ‘food’: but food comes with its own set of indigestible regulatory challenges

By Ikigai Law | Health-tech | 0 comment | 10 March, 2022 | 4

In this post, we unpack the history of the cannabis plant, and the FSSAI’s acknowledgement of cannabis derivatives under the category of food. What’s legal but seems almost illegal? For the investors on Shark Tank India[i], it’s hemp businesses. While, there’s not much that hasn’t already been said about the TV show, but there’s aRead more

Introducing more transparency in India’s medical device price regulation methods

By Ikigai Law | Health-tech | 0 comment | 3 February, 2022 | 2

This post dives into the trade margin rationalisation approach for price regulation of medical devices, and suggests ways to increase transparency while using the approach. Background: In July 2021, the National Pharmaceutical Pricing Authority (Pricing Authority), through a notification (July 2021 notification) announced that it would regulate the prices of five medical devices: (i) pulseRead more

Expanding scope of price control of medical devices – a chink in the armour of ‘Atmanirbhar Bharat’?

By Ikigai Law | Health-tech | 0 comment | 15 March, 2021 | 3

This post explores the National Pharmaceutical Pricing Authority’s powers of price control and monitoring on the Indian medical device industry against the backdrop of India’s drive towards an ‘Atmanirbhar Bharat.’ Introduction: There are many barriers to affordable healthcare in India[1]. Several initiatives and mechanisms have been suggested over the years, to tackle this. One mechanismRead more

Regulation for rigorous clinical investigation of medical devices: the missing link of the Atma-nirbhar drive in healthcare

By Ikigai Law | Health-tech | 0 comment | 26 February, 2021 | 2

This post examines two unaddressed areas of the clinical investigation process under the Medical Device Rules, 2017. Introduction: India aims to be the pharmacy of the world.[1] To achieve this dream, it is important that drugs and medical devices “made-in-India” are trusted by regulators and users globally. A robust regulatory framework for evaluating and approvingRead more

De-coding the Clinical Investigation process under the Medical Device Rules, 2017

By Ikigai Law | Health-tech | 0 comment | 19 February, 2021 | 6

This post describes the clinical investigation process under the Medical Devices Rules, 2017. Introduction: The Indian healthcare industry has risen to the challenge of providing affordable drugs domestically and internationally. India has earned the reputation of being the pharmacy of the developing world[1]. However, to extend this reputation for medical devices, Indian regulators will needRead more

National Digital Health Mission Sandbox: a golden opportunity for the HealthTech industry

By Ikigai Law | Health-tech | 0 comment | 29 January, 2021 | 4

This post explores why participating in the NDHM Sandbox is a golden opportunity for the HealthTech industry. Introduction: The Government needs a robust technical infrastructure backing its goal to expand access to quality healthcare through the National Digital Health Mission (NDHM’). It needs technology solutions to create the various building blocks of the NDHM andRead more

Medical devices regulation in India: tracing its evolution to gets cues on its future development

By Ikigai Law | Health-tech | 0 comment | 21 December, 2020 | 3

The medical devices industry needs robust regulations. This article traces the evolution of medical devices regulation in India. Medical devices whether syringes and swabs, implantable devices, or technologically advanced solutions like software-driven devices, play a key role in the monitoring, prevention, and management of various diseases. A robust and dynamic regulatory system to oversee theRead more

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