Health-tech law roundup
- Drugs and medical devices regulator begins work on single window for regulatory activities: The Central Drug Standards Control Organisation (CDSCO) floated an expression of interest for a software service provider, to digitally transform the CDSCO and to set up the ‘Digital Drugs Regulatory System’ (DDRS). The DDRS is aimed at increasing confidence in drugs and medical devices and will be a single sign in and window for all regulatory activities. The DDRS will bring together state and central government regulators and agencies and the industry. And will integrate with central government platforms such as Aadhaar and DigiLocker. Interested software providers may apply by 7 December 2023
- Department of Pharmaceuticals releases draft paper on a national pharmaceutical policy for comments: The department floated an “Approach Paper on Draft National Pharmaceuticals Policy 2023 for stakeholder consultation” (the Paper). The Paper hopes to holistically support India’s place as the Pharmacy of the World, and to ensure access to affordable healthcare in India, through encouraging regulatory ease, adherence to global quality standards, and research and funding/investments. It identifies eleven focus areas: (a) nurturing and promoting research, development and innovation; (b) ensuring affordable, accessible and equitable access to health coverage; (c) facilitating access to funding; (d) regulatory harmonisation; (e) creating conducive regulations including price regulation and transparency; (f) initiating capacity building and development of skilled manpower; (g) enhancing policy and program interlinkages; (h) international collaboration; (i) infrastructure enhancement; (j) leveraging digital transformation; (k) sustainability, reducing carbon footprint; and (l) strengthening of intellectual property. Comments may be submitted by 30 November 2023.
- Union government probing Indian Council of Medical Research (ICMR) health data breach: Rajeev Chandrasekhar, Union IT Minister of State, stated that CERT-In – India’s cybersecurity watchdog – is investigating the breach of health data from ICMR’s COVID testing database. The minister noted that health data was not stolen, and that several government departments had access to the COVID database. In early October, Resecurity, a US-based cybersecurity firm flagged the leak of personally identifiable information of 81.5 crore Indians on ICMR databases. Data included names, addresses, passport information and AADHAR.
- Government considering guidelines for over-the-counter medicines: A. K. Pradhan, the Joint-Controller of the CDSCO, indicated that the government is considering providing guidelines to sell medicines without prescriptions (i.e., over-the-counter drugs. OTC). The move will be aimed at reducing the burden on doctors and increasing access to medicines for patients. And will impact which drugs need prescriptions, when sold through e-pharmacies. Earlier, the National Medical Commission’s National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 (the Regulations), set out a list of OTC medicines. The Regulations were put on hold after stiff opposition from doctors, on the mandate to prescribe only generic medicines to patients.
Digital health roundup
- India-Netherlands to cooperate on regulation of medical products: A memorandum of understanding (MoU) was signed to enhance the quality of medical products and healthcare services in the two countries. The signing took place at the World Local Production Platform (an initiative of the World Health Organisation) in the Netherlands.
Public health roundup
- ICMR to use drones for transport of biopsies and diagnostic samples: The ICMR is working with TSAW Drones, to carry diagnostic and biopsy samples in its drones’ study. The move will help study the effect of unconventional transport on biopsies and diagnostic samples (e.g., if blood sample quality is impacted by the drone’s vibrations). As part of the study- (a) biopsies will be carried by drones, in Manipal, Karnataka and Lahul, Himachal Pradesh and (b) tuberculosis medicines in Yaddari, Telangana. As part of a feasibility study, ICMR will rely on TSAW Drones, to transport sputum samples of drones in the Yadadri Bhuvanagiri district of Telangana. The feasibility study will be a part of the National TB Elimination Programme and will commence in December 2023. ICMR will partner with AIIMS-Bibanagar and local primary healthcare centres for the study.
- South Korea sets up body to promote bio-healthtech: South Korea established the Bio-health Innovation Commission to support the biohealth industry to integrate new technologies such as AI and nanotechnology. The commission will have the Prime Minister and the ministers of 12 government ministries, such as the Ministry of Health and Welfare. The commission will also have academic experts and representatives from the bio-health industry.
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