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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

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

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

Ikigai Law and the Public Health Foundation of India (PHFI) organised a panel discussion on ‘Matters of Accountability – ‘Regulatory Framework for driving safe digital healthcare adoption in India’. This discussion was a part of PHFI and IDS’s three-part series ‘Digital Health interventions through a Health System Lens: preparing for inclusive, integrated and accountable digitalRead more

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

The post is an overview of our comments to the National Health Authority’s consultation papers on a proposed building block of the National Digital Health Mission, namely the unified health interface. The consultation papers sought comments on the design and governance for creating and sustaining the unified health interface . Background: In August 2020, PrimeRead more

The post is an overview of our comments to the National Health Authority’s consultation papers on two building blocks of the National Digital Health Mission, namely the health facility registry and the healthcare professionals’ registry. The consultation papers sought comments on the design and governance of these building blocks. Background: In August 2020, Prime MinisterRead more

1. Introduction: In telehealth, technology platforms aggregate healthcare professionals and services and facilitate interactions between these professionals, patients, and services. Many such platforms go beyond just being audio/video calling or messaging tools for doctors and patients. They offer services like (i) management of appointments; (ii) tools that aid diagnostics or remote monitoring of patients, orRead more

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

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