TechRx: January 2024 Edition1

Health-tech law roundup

- Medical devices’ regulator announces a single regulatory window for ease of business: To promote ease of doing business, Invest India and Tata Consultancy Services launched the “National Single Window System” for getting regulatory approvals from Union and State government agencies. The Central Drugs Standard Control Organisation (CDSCO) announced that the portal can be used for obtaining three approvals under the Medical Devices Rules, 2017 (e.g., certificate of registration of a notified body under Form MD-1). The Association of Indian Medical Device Industry (AiMeD) noted that the success of the portal depends on the ability to use it to obtain all relevant licenses, from all relevant ministries (i.e., if setting up a medical device factory in a state requires 10 licenses, all should be obtainable through a single portal). Per the CDSCO notification, other portals would be disabled for use, by 15 January 2024, for the three approvals.

- Union Health Minister inaugurates new sub-zonal office of CDSCO: Mansukh Mandaviya, the Union Health Minister, inaugurated a new Sub-Zonal Office (SZO) and Central Drug Testing Laboratory (CDTL) in Indore. The SZO and CTDL will oversee regulation of medical devices, drugs, and cosmetics. And ensure proper implementation of the Drugs and Cosmetics Act 1940, and allied rules. The minister noted that the SZO will ensure quality products for patients and ease of doing business for the pharmaceutical industries in Madhya Pradesh.


Digital health roundup

- Medical devices industry body reiterates government to withdraw import duty exemption: AiMeD reiterated its earlier request to the Union government to withdraw import duty exemptions for medical devices. In its pre-budget asks, AiMeD argues that this will help encourage local manufacturing and sale of medical devices, by reducing reliance on imports of medical devices

- Drone Didi Scheme (Scheme) to enable delivery of healthcare products: TechEagle, a drones’ manufacturer completed one of the longest drone deliveries with All India Institute of Medical Sciences, Rishikesh (AIIMS-R). The deliveries went from AIIMS-R to primary and community healthcare centres in remote areas. The drones transported TB medicines with support from the Scheme over 47kms and approximately 2.5kms in altitude of challenging terrain. Similarly, Skye Air secured a mandate with the Union Health Ministry and the Regional Leprosy Training Research Institute, Aska, for drone delivery of medicines, diagnostics, emergency services to remote areas, in eastern India. Finally, Ambikapur Medical College (AMC) and Government Doon Medical College will use drones to transport medicines, medical kits, and diagnostic samples, under the Scheme. The Drone Federation of India will provide the drones to AMC.


Public health roundup

- Himachal Pradesh to roll out Health Information Management System (HIMS) project: The project is intended to ensure seamless access to healthcare by eliminating the need to carry physical health records by ensuring doctors can access patient records based on their phone number. In a meeting with the state’s health department officials, Shri. Sukhvinder Singh Sukhu, the state’s Chief Minister, called for launching the initial phase of the HIMS project in 56 hospitals. The Chief Minister stressed on timely implementation of the HIMS to ensure it properly retrieves patient records from the cloud-based server.

- Karnataka to get Tele-ICU hubs: The first Tele-ICU hub was inaugurated by the state’s Health Minister, Shri Dinesh Gundu Rao, at the Karnataka Institute of Medical Sciences (KIMS) in Hubballi, earlier this month. Ten hospitals are connected to the KIMS Tele-ICU hub. The hub was set up with the help of the Union Health Ministry and is intended to manage patient admissions at district hospitals. Specialist doctors can advise patients admitted in Taluk level hospitals, remotely. Other such Tele-ICU hubs will be set up in Bangalore and Ballari.

- AI powered telemedicine launched in Ramnagar region (Jammu and Kashmir): Dr. Jitendra Singh, the Union Minister of State for Science and Technology, launched “Aarogya - Doctors on Wheels”, an AI powered telemedicine mobile clinic for Dudu Basantgarh in the Ramnagar region. Patients can narrate their complaint/ illness to Aarogya in their native language, and the AI doctor will respond in the same language, to connect the patient to leading super-specialists in various partner hospitals. The patient’s body profile and body investigations are done and in approximately 50 minutes and the patient is given a prescription.


Image credits: Ikigai Designs  

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


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