Blog

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

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

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

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

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

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

This post traces the timeline of events leading to the formulation of e-pharmacy rules passed by the government of India and the current status of online sale of drugs. Introduction: E-pharmacies have played a prominent role during the Covid-19 pandemic. A FICCI white paper indicates a 2.5 times growth in the number of households usingRead more

Propelled by the Covid-19 crisis, the government recently released “telemedicine practice guidelines”. Tanya Sadana and Sreenidhi Srinivasan of Ikigai Law hosted a webinar to discuss the legal and practical challenges of telemedicine. They were joined by Dr. Guriqbal Singh Jaiya (co-author of Fundamentals of Telehealth and Telemedicine, 2019) and Dr Manuj Garg (co-founder of healthcareRead more