TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, 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.

1. Through an FIR filed by a health activist, it was found that thirty doctors from nine states were found guilty of accepting luxury foreign trips worth ₹1.9 crore from a pharma company. While 27 names were sent to the NMC, several state medical councils failed to act. The NMC has now sent reminders to State Medical Councils of Assam, Delhi, Karnataka, Kerala, Telangana and WB to expedite action and warning it may intervene if delays persist, to ensure accountability and compliance across medical practice.
Source: shortlink.uk/1wLSY

2. India’s central government is reportedly considering to extend the customs duty exemption on critical petrochemical inputs used by the pharmaceutical industry beyond the current June 30, 2026 deadline. The proposal is being examined in view of continued supply chain disruptions and rising input costs linked to the ongoing geopolitical tensions in West Asia. The duty relief, originally introduced as a temporary measure in April 2026, covers several petrochemical products that serve as key raw materials and intermediates for pharmaceutical manufacturing. Government officials have indicated that an extension may be considered if prevailing conditions continue to impact the availability and cost of essential inputs.
Source: shortlink.uk/1rkQs

3. The Government is reportedly working on a proposal to strengthen the financial viability of Jan Aushadhi Kendras by revising the incentive structure, increasing retailer margins, extending credit periods, and addressing losses arising from expired inventory. Under the proposed measures, product margins for Kendra operators may be gradually increased to as much as 50%, while credit periods for retailers could be extended from 45 days to 75 days to ease working capital requirements. The plan also contemplates mechanisms for absorbing losses on expired medicines and enhancing support across the supply chain. These measures are aimed at improving inventory availability, supporting sustainable operations of Kendras, and facilitating the continued expansion of the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) network across the country.
Source: shortlink.uk/1wLTd

4. The Madras High Court has ruled in favour of a pharmaceutical innovator company in a patent infringement dispute concerning the export of an Active Pharmaceutical Ingredient (API). The Court held that the defendant’s export activities were not protected under the Bolar exemption as the defendant failed to produce regulatory documentation demonstrating that the exports were solely for purposes permitted under the provision. The Court further held that a prior consent decree entered into by the defendant operated as issue estoppel, preventing it from subsequently challenging the validity of the patent. Consequently, the Court granted relief restraining the infringing activities and reaffirmed the evidentiary requirements for entities seeking to rely on the Bolar exemption for export-related activities.
Source: shortlink.uk/1wLTi

5. The Delhi High Court has issued notice in a trademark infringement and passing off suit filed by a pharmaceutical company alleging that several medicinal product marks adopted by the defendants are deceptively similar to its registered and applied-for trademarks. The plaintiff contends that the impugned marks are likely to cause confusion and deception among consumers, particularly in the pharmaceutical sector where a higher standard of care is required to avoid medication errors. Considering the plaintiff’s application for interim relief, the Court has sought a response from the defendants and directed them to file their reply within three weeks. The matter will now proceed for consideration of the plaintiff’s request for an ex-parte ad-interim injunction and other reliefs.
Source: shortlink.uk/1wLTw

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, 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.

1. India’s Central Food regulator, the Food Safety and Standards Authority of India (FSSAI) has issued a advisory to e-commerce Food Business Operators (FBOs) to ensure that: (1) Last-mile delivery systems are made more robust, and persons handling last-mile delivery are given suitable training to handle the food items, and (2) The e-commerce FBOs are compliant with the labelling requirements as specified in relevant regulations, keeping the listings on the website consistent with content of actual food label.
Source: bit.ly/4f0zEaA

2. India’s Ministry of Finance has published an Office Memorandum seeking public comment up to the 10th of December, on certain amendments to the prevailing insurance regulations in the country. These proposed amendments include among other things, permitting a 100% Foreign Direct Investment in the insurance sector through the automatic-route, and permitting insurers to undertake offer of more than one class of insurance.
Source: bit.ly/4ifYwxT

3. India’s Central Ministry of Consumer Affairs is reportedly developing an online portal to handle the licensing, verification and stamping of weighing and measurement instruments as well as to provide a source of information on verified trade instruments for consumers.
Source: bit.ly/41km5Q6

4. The High Court of the States of Punjab and Haryana held that outside of introduction of evidence to the effect, the mere failure of a medical surgery/ procedure would itself not be sufficient to establish medical negligence claims, especially if the patient had been appropriately sensitized of the risks involved.
Source: bit.ly/49nlkrJ

5. In its finalized version of the regulations regarding Pre-determined Change Control Plans, the US Food and Drug Administration has plainly classified Artificial Intelligence (AI) as a sub-set of Machine Learning softwares when it comes to regulation of Medical Devices, and further makes it mandatory that in making submissions the version of the device software need to be submitted with the FDA to ensure version control.
Source: bit.ly/4imQQu2