TechRx: January 2024 Edition 2

Health-tech law roundup

- Government considering requiring health sector companies to use Indian cybersecurity products: The National Critical Information Infrastructure Protection Centre (under the Prime Minister’s Office) and National Cybersecurity Coordinator, are reportedly planning to release the “National Cybersecurity Reference Framework”. The framework will require companies in critical sectors like healthcare to use Indian made cybersecurity services and products and set out roles and responsibilities based on existing laws. And will be accompanied by three compendiums that detail international cybersecurity standards, products, and solutions. The framework was reportedly circulated with companies and government departments in May 2023, but has not been released for public consultation. 

- Open Network for Digital Commerce (ONDC) wants to facilitate sale of medicines: T. Koshy, Managing Director of ONDC, cited ongoing talks with the Union Health Ministry to improve access and affordability of medicines. However, unnamed sources from the Health Ministry state that the ministry is reportedly not in favour of online sale due to data privacy concerns and irrational sale of drugs. Koshy noted that the ONDC can connect consumers and healthcare providers with a wide range of pharmaceutical products.


International roundup

- World Health Organisation (WHO) issues guidelines for safe use of technologies like ChatGPT in healthcare: The WHO released “Ethics and governance of artificial intelligence for health: Guidance on large multi-modal models” (LMMs) with over forty recommendations for governments and developers to protect patient health. The guidelines outlined various use cases (e.g., responding to patient’s written queries). And risks to people’s health and safety (e.g., false, biased, or inaccurate statements that cause harm to patients relying on them). The WHO recommendations for governments include assigning a specific agency to approve LMM applications in healthcare. And investing in non-profit or public infrastructure (e.g., for public data sets or computing power) which require developers/users to adhere to ethical principles in exchange for access to the infrastructure. The WHO recommendations for developers include engaging relevant stakeholders to share their perspectives, early in the development process (e.g., scientists, doctors and patients) in a structured manner. Thus far, AI healthtech companies have reacted positively to the guidelines. However, Luz Eruz, Chief Technology Officer of MDClone, noted that the guidelines missed discussing the use of synthetic data (i.e., artificial data that replicates statistical characteristics of real-world data) to train LMMs. 

Interim budget 2024 roundup

- Launch of digital platform to manage immunisation in India: Union Finance Minister, Nirmala Sitharaman, announced the launch of U-WIN to manage immunisations under India’s drive to achieve full immunisation, Mission Indradhanush. U-Win will record vaccination status, and list of vaccines taken by children. Mission Indradhanush aims to ensure vaccinations against diseases such as tuberculosis and polio. 

Tax rates and certain benefits to startups to remain the same: The Union Finance Minister also announced that indirect and direct taxes and import duties would remain the same as the 2023-2024 budget. The minister added that existing tax benefits for startups would be renewed till 31 March 2025, to ensure continuity of business. The MedTech industry lauded the overall focus on health in the interim budget but expressed concerns on the customs duty for medical devices. Medical Technology Association of India (MTaI) flagged that lower custom duties for medical devices would encourage FDI in the sector. The Association of Indian Medical Device Industry (AiMeD) flagged that increased import duties would boost Indian manufacturing of medical devices and make it a global manufacturing hub. 


Digital health roundup 

Senior NITI Aayog health member says MedTech Mitra intended to connect innovators with clinical researchers and funding: Dr. Vinod K. Paul, Member, NITI Aayog (the Union Government’s think-tank), highlighted some challenges faced by innovators through the lifecycle of the MedTech innovation. Dr. Paul noted that MedTech products will need animal studies and clinical investigations to ensure clinical readiness; adding funding and technical ability to conduct such studies could be a challenge for innovators. In his op-ed, Dr. Paul noted that MedTech Mitra was launched to be an ecosystem and not a portal, to tackle such problems. For instance, innovators will be connected to the Indian Council of Medical Research’s (ICMR) pre-clinical/ clinical trials networks or research institutions. Dr. Paul stated that roughly 80 innovators have connected with MedTech Mitra since its launch in December 2023. 

 Four regulatory approvals for drugs go live through newly launched single window portal: Earlier this month, the Central Drug Standards Control Organization, India’s drugs and medical device regulator, announced that three medical device regulatory approvals are live on the National Single Window System. On 16 January 2024, the regulator announced that four regulatory approvals for drugs, can be sought through the NSWS (e.g., application for license to import a ‘new drug’ for clinical trial or bioavailability study or bioequivalence study, or for examination, test, and analysis). 


Public health roundup 

- ICMR releases national research priorities and call to update national essential diagnostics listThe ICMR has called expressions of interest to conduct funded research in priority areas including mental health, cancer, and tuberculosis. The call does not mention a last date for application while setting out eligibility criteria to apply. The ICMR also seeks suggestions to update India’s National Essential Diagnostics List, which lists the minimum quantity of medical devices and in-vitro medical devices (e.g., reagents or chemicals used on body samples to test for HIV) used for diagnostics that must be maintained at various levels of healthcare. Suggestions may be shared by 29 February 2024.


Image credits: Ikigai Designs 

Author credits: This newsletter is brought to you by our health-tech team. 



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