TechRx: November 2023 Edition 2

Health-tech law roundup 

  • Court directs Indian government to frame policy for epharmacies: The High Court of Delhi has given the Indian government eight weeks to form a policy for online sale of medicines. The court acknowledged the delay in framing the policy, while noting the government’s argument that consultations were on going, on the previously released draft e-pharmacy rules 2018. The next hearing is scheduled for 4 March 2024.  

  • Epharmacies face backlash from Madhya Pradesh Chemist Association: At the association’s annual general meeting, the President, Gautam Chand Dhing cast doubts on the quality of drugs sold by epharmacies. Dhing alleged that online pharmacies were selling spurious or adulterated, and that online sale of drugs could seriously impact patients’ health through misuse and self-medication. Dhing noted that the government does not have a mechanism to regulate or approve facilities where online sales take place. The association has raised the issue with the governments of India and Madhya Pradesh and will discuss it at the All India Chemists Association Conference, next month.  

  • Drugs regulator to create standard operating procedures (SOPs) for videography of samples and testing: At its 62nd meeting, the Drugs Consultative Committee (DCC) discussed leveraging digital tools to prevent tampering/ corruption of samples. The DCC urged the Union Health Ministry to create SOPs for videography of receipt of samples, opening seals, and distribution of samples to the analyst. The DCC called for setting up a sub-committee with (a) two persons each from the Central Drugs Laboratory and State Drugs Laboratory, (b) one from the Central Drug Standards Control Organisation (CDSCO, India’s drugs and medical devices regulator), and (c) one technologist with relevant expertise to give recommendations. The move was discussed to ensure integrity of the drugs testing process, and will augment the Union Health Ministry’s ongoing work to take drug inspectors’ recommendations online. The DCC is set up under the Drugs and Cosmetics Act, 1940, to advise the CDSCO, state regulators, or the Union/state governments.  

Digital health roundup 

  • Union Health Minister highlights role of digital public goods in public health: Speaking at the ‘Health Ministers’ Session’ of the 2nd Voice of Global South Summit, Mansukh Mandaviya, the Union Health Minister, pointed to the role of digital platforms and networks in tackling healthcare challenges. And improving equitable access to medical resources. The minister re-affirmed development of digital health solutions to tackle the Global South’s healthcare challenges, as one of India’s key priority areas. 

  • India’s drug regulator head calls for Indian industry to shift from volumes to a value game for continued ‘Pharmacy of World’ status:Rajeev Raghuvansh, the Drug Controller General of India (heads the CDSCO), called for India’s pharmaceutical and medical devices industries to invest more in research and development of drugs and medical devices. And not to merely focus on generic medicines or global innovations. Raghuvansh noted that the Indian government’s efforts towards this includes regulatory reforms including the Drugs Cosmetics and Medical Devices Bill 2023, which could be tabled in the next session of Parliament. The government has put forth various schemes and programmes to support such R&D (e.g., the Production Linked Incentive Scheme). 

  • Healthcare advertisements on digital platforms found to be most violative of advertising code: The Advertising Standards Council of India (ASCI), found that healthcare advertisements, largely on digital platforms (nearly 80% assessed by ASCI) violate the code more than other segments till the end of September 2023. The body has referred 565 violative ads to the Ayush Ministry. ASCI found some advertisements (Ads) making claims that violate the Drug and Magic Remedies (Objectionable Advertisements) Act of 1954 (DMRA). The DMRA lays out how drugs may be spoken about. ASCI is the advertising industry’s self-regulatory body, with a self-regulatory code for monitoring advertisements on various platforms. ASCI can look into complaints received against Ads or look into Ads on its own, to assess if they are misleading, offensive, harmful, or unfair towards competitors. 

Public health roundup 

  • Kerala government uses health app to screen roughly 1.5 crore people for lifestyle diseases: Under the ‘Ardram Mission’, the Kerala Health Department, has screened people above 30 years of age for lifestyle diseases. The government aims to identify hypertension, diabetes, cancer, tuberculosis, and lung diseases at an early stage. ASHA workers use an app created by eHealth, to conduct door-to-door screening. At risk individuals identified through the screening, are checked and diagnosed with follow-ups. 

  • Madhya Pradesh government looks to AI for cancer screening: The Madhya Pradesh Health Department is examining  the use of AI enabled computer analysed thermal images for generating automated interpretation reports that indicate breast cancer. The project proposal reportedly aims to cover 351 community health centres, where women will be screened based on medical advice. 

International roundup: 

  • Rules of origin and customs duties concessions for medical devices are sticking points in India-United Kingdom (UK) free-trade-agreement (FTA): An unnamed official in the Union Government stated that the ‘rules of origin’ and custom duties concession are being negotiated by India and UK. ‘Rules of origin’ clause reportedly provides the minimal processing that should happen in an FTA country, to consider it as originating from that country. The clause reportedly prevents dumping of products made in third-party countries, into India, by requiring some value addition in that product before it is exported to India. India imports 80% of its medical devices from countries including the United States (US), Germany, Singapore, and Netherlands. And the negotiation come at a time when the Union Government is encouraging India’s local manufacturing of medical devices and pharmaceuticals’ industries, through various schemes (e.g., MedTech parks, Production Linked Incentives). Experts such as Rajinder Singh Kanwar from the Export Promotion Council For Medical Devices, state that the Union Government should not give concessions on customs duties for medical devices manufactured in India, to encourage local manufacturing.  

  • US’s Food and Drugs Administration (FDA) to withdraw from exercise to globally harmonise medical device regulation: The Global Harmonization Working Party (GHWP) is an international effort to align medical devices regulations globally. The US FDA will withdraw from the GHWP, after raising concerns on the ‘divergent harmonisation efforts’. In a 27 November 2023 letter, the FDA alleges that the GWHP’s leadership does not represent the diversity of global perspectives. And that its efforts do not align its priorities or international best practices, adding that the GWHP should have greater collaboration with the International Medical Devices Regulators Forum (IMDRF). Members of the GHWP are China, India, South Africa, South Korea, Chile, and Saudi Arabia. Membership of the IMDRF is wider, and includes the European Union, Canada, China, Japan, South Korea, and Australia. 



Image credits: Ikigai Designs 

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



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