Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Prior Government approval not necessary for using unreliable or untested artificial intelligence (AI) in India
India’s Ministry of Electronics and Information Technology (MeitY) has revised its controversial advisory on use of AI, and has done away the requirement of permission from Indian Government prior to use of under-testing/unreliable AI products. However, the requirement to label under-testing/unreliable AI products prior to making them available to users, and to obtain informed consent prior to use of such products by users continues.
Source: bit.ly/3VlHOUI
Indian Patent Rules have been amended significantly
The Patent (Amendment) Rules, 2024 notified by India’s Ministry of Commerce and Industry have introduced several key changes to patent framework. The time-limits for foreign applications, notice of pre-grant oppositions and request for examinations has been revised. Additionally, the revised rules now require permit a patentee or a licensee to furnish a statement of working of patent only once every three years, as opposed to once every year.
Source: bit.ly/49TDwZl
India’s Food Regulator confirms that there is no specific food standards for seeds of fruits and plants
India’s Food regulator, Food Safety and Standards Authority of India (FSSAI), has confirmed that there are no specific food standards for edible dried seeds obtained from fruits and vegetables as of now. Importers and manufacturers can follow the current standards and obtain license under the parent category of dried fruits and dried vegetables till such time specific standard is notified by FSSAI.
Source: bit.ly/3VnSNNI
India’s New Code on Interaction between Industry and Doctors may not be enforceable
India’s Department of Pharmaceuticals (DoP) published Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024 to regulate the interaction between doctors and pharma and medical device companies. The DoP has not described UCPMP 2024 as voluntary, which it had done in for UCPMP 2015. This implies that the UCPMP may be mandatory. However, concerns are being raised by experts on the enforceability of UCPMP 2024 due to absence of statutory backing.
Source: bit.ly/3vj0JoH
India’s antitrust regulator to examine in-app billing practices of Google
The Competition Commission of India (CCI) has initiated an investigation against Google for abusing its dominant position through its new user Choice Biling System. CCI has taken a prima facie view, based on information received by multiple stakeholders, that Google’s new policy skews and disrupts market competition in the downstream app markets and continues to favour Google’s apps while cementing its position in the payment processing market as well.
Source: bit.ly/3THykCh