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 Directorate General of Foreign Trade(DGFT), issued a Public Notice dated 1 June 2026 and has notified six new Standard Input Output Norms (SIONs) under the Chemical and Allied Product Group for specified pharmaceutical products. The notification enables Regional Authorities to grant Advance Authorisations without case-specific referrals to the Norms Committee, thereby reducing processing timelines, ensuring uniformity in approvals, and promoting ease of doing business for pharmaceutical exporters.
Source: shortlink.uk/1q-yS

2. The Delhi High Court directed CDSCO to review safety concerns over semaglutide injections within two months. A patient petition claims that manual calculation of dosage deviates from global pre-filled pen standards, risking overdose, underdose, and misuse. CDSCO must determine if approval aligns with patient safety and international practices.
Source: shortlink.uk/1q-xi

3. The Indian government is reportedly drafting new organ transplant rules to introduce Donation after Circulatory Death (DCD) and strengthen frameworks for organ swaps and brain-stem death donations. The proposed reforms aim to expand the donor pool, standardise transplant procedures, and improve access to life-saving organ transplants.
Source: shortlink.uk/1q-z5

4. The Maharashtra State Consumer Disputes Redressal Commission has held that obtaining a patient’s signature on a pre-printed consent form without adequately disclosing the nature of the procedure, associated risks, possible complications, and available alternatives does not constitute valid informed consent. The Commission observed that a mere signature on a standardised form cannot satisfy a doctor’s duty of disclosure and ruled that failure to obtain proper informed consent amounts to a deficiency in service. While the Commission found no evidence of medical negligence in the performance of the surgery or post-operative care, it held the medical practitioner liable for not securing valid informed consent and awarded compensation.
Source: shortlink.uk/1q-za

5. The Central Drugs Standard Control Organisation has directed pharmaceutical manufacturers to establish and maintain pharmacovigilance systems in line with revised Schedule M requirements. Companies must maintain dedicated adverse reaction monitoring mechanisms, appoint qualified pharmacovigilance officers and keep detailed records, with compliance subject to regulatory inspections.
Source: shortlink.uk/1q-xq

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. The Kerala High Court has held that registered medical practitioners cannot enrol in another profession, including law, without first cancelling their medical registration, observing that mere cessation of medical practice or cancellation of a clinic licence is insufficient. The ruling reinforces restrictions on simultaneous professional practice and clarifies enrolment eligibility requirements under legal and medical professional frameworks.
Source: shortlink.uk/1vtU9

2. Maharashtra plans to replace the Bombay Nursing Homes Act, 1949 with the Clinical Establishment Act, 2025, mandating registration of all healthcare facilities. Defaulters face heavy fines and imprisonment. The law requires transparent fee display, standardized rates, and treatment protocols, though medical associations criticize it as burdensome.
Source: shortlink.uk/1q6ni

3. India is reportedly planning to establish a national registry to track implantable medical devices and the patients receiving them, with the objective of strengthening post-market surveillance, traceability, and patient safety oversight. The proposed framework is expected to cover devices such as cardiac stents, pacemakers, orthopaedic implants, and other high-risk medical devices through a centralised digital monitoring mechanism. The move marks a significant regulatory shift by increasing accountability, improving adverse event monitoring.
Source: shortlink.uk/1vtUh

4. India is reportedly planning to introduce DNA-based testing mechanism to bolster oversight of buffalo meat shipments and identify any illegal mixing of cow meat in export consignments. The initiative seeks to improve traceability across the meat export supply chain, address product authenticity concerns flagged by importing nations, and tighten adherence to export compliance norms. The development points to a broader regulatory push to align India’s meat export ecosystem with rising global standards on food safety and quality assurance. It is likely to raise the compliance bar for exporters, testing laboratories, and processing units operating in this space.
Source: shortlink.uk/1q6nz

5. India’s pharmaceutical industry is reportedly witnessing financial pressure from rising raw material and operational costs alongside weakening export demand in key overseas markets. The combined impact is squeezing profit margins and disrupting growth momentum for drug manufacturers already navigating pricing controls and global market volatility.
Source: shortlink.uk/1q6nJ

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. National Pharmaceutical Pricing Authority (NPPA) has exempted Nafithromycin 400 mg tablets from price control under DPCO, 2013 for five years. The exemption starts from launch or patent expiry, whichever is earlier. This allows flexible pricing, but the company must report launch date and price details to the authorities
Source: shortlink.uk/1mYOh

2. The Centre has set April 30, 2026 as the final deadline for private hospitals to complete empanelment under the Central Government Health Scheme. Hospitals failing to sign the Memorandum of Agreement (MoA) by the deadline will be de-empanelled from May 1, losing eligibility to treat CGHS beneficiaries or submit reimbursement claims.
Source: shortlink.uk/1mYOm

3. US pharmaceutical companies have reportedly opposed price caps imposed by the National Pharmaceutical Pricing Authority (NPPA) of India, seeking blanket exemption for patented medicines. Industry stakeholders argue that current controls reduce prices by nearly 50% post-patent expiry, discouraging innovation and limiting availability of advanced therapies in India.
Source: shortlink.uk/1mYOq

4. The Karnataka Department of Health and Family Welfare, in collaboration with National Institute of Mental Health and Neurosciences, released a draft policy to tackle student mobile addiction. The proposal caps recreational screen time at one hour daily, introduces digital wellness committees, and mandates teacher training and counselling support to address rising mental-health concerns among adolescents.
Source: shortlink.uk/1mYOs

5. India’s Ministry of Finance has reportedly temporarily exempted customs duty on forty petrochemical and chemical inputs until June 30, aiming to stabilise supply chains disrupted by Middle East tensions, ease cost pressures on pharmaceuticals and manufacturing sectors, and support industry facing sharp increases in raw material and packaging costs.
Source: shortlink.uk/1mYOu