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. Punjab’s Food and Drugs Administration (FDA) has cancelled a pharmaceutical manufacturer’s licence and ordered a nationwide product recall following findings that allegedly linked substandard oxytocin injections to maternal deaths. The action highlights increased scrutiny of GMP compliance and data integrity, signalling stricter enforcement where product quality deficiencies may endanger patient safety.
Source: shortlink.uk/1rjtj

2. Maharashtra’s FDA has uncovered a supply of falsely labelled “sterile” surgical gloves to government hospitals in Mumbai. The gloves were allegedly unsterilised due to company’s sterilization machine was malfunctioning, prompting raids and seizure of stock. The company responsible had attempted to recall the unsterilized surgical gloves before the raid with no success. Authorities are investigating licensing violations and whether proper recall procedures were followed.
Source: shortlink.uk/1rjtr

3. A U.S. federal court has allowed a proposed class-action lawsuit to proceed against a manufacturer of a children’s nutritional drink over allegations that its marketing and packaging misled consumers into believing the product was clinically proven to help children grow taller. The court held that product claims, combined with visual branding and advertising elements, could reasonably be interpreted by consumers as referring to height growth rather than general growth and development. The lawsuit alleges that consumers were misled regarding the product’s benefits, while the company maintains that its claims are scientifically supported and appropriately describe the product’s role in supporting children’s growth and development. The case will now proceed for further judicial consideration.
Source: shortlink.uk/1rjtH

4. India’s Directorate General of Foreign Trade has exempted Special Economic Zone (SEZ) units and developers from the applicability of conditions of Quality Control Orders (QCO) and Bureau of Indian Standards (BIS) rules. This exemption will be applicable on the permissible good imported like raw materials and capital goods which are authorized for SEZ operations. However, if these imported items or their resulting manufactured products are moved into the Domestic Tariff Area (DTA), they will be required to fully comply with all applicable QCO and BIS laws. Additionally, SEZ entities will have to submit a formal undertaking to the Development Commissioner at the time of import.
Source: shortlink.uk/1rjtg

5. The United States Food and Drug Administration is conducting a scientific safety review of mifepristone, the abortion pill, using existing drug safety systems. The review could influence future distribution requirements for the medicine. While the agency maintains that mifepristone is safe and effective when used as directed, abortion rights groups have criticized the review.
Source: shortlink.uk/1rjtT

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. Parliament passes Jan Vishwas Bill 2026, bringing major relief to India’s cosmetics sector. Minor violations in the case of cosmetics (other than spurious or adulterated) which were previously punishable with up to one year’s imprisonment will now be resolved outside courts through a civil penalty framework, with fines of Rs.1 lakh or three times the value of confiscated goods, whichever is higher.
Source: shortlink.uk/1sCvW

2. The Central Government has amended Para 2.62 of the Foreign Trade Policy 2023 to streamline the issuance and verification of Certificates of Origin (CoO). The amendment clarifies that only Directorate General of Foreign Trade (DGFT)-authorised agencies can issue CoOs, and mandates exporters to use identical invoice numbers in both CoOs and corresponding shipping bills to enable automated verification.
Source: shortlink.uk/1sCw6

3. India’s leading manufacturer of Paracetamol tablets and active pharmaceutical ingredients plans to digitise manufacturing records, enhance quality oversight, and increase real-time monitoring after the U.S. Food and Drug Administration cited record-keeping gaps, cleaning lapses, and contamination control failures at its largest Telangana facility. While production continues, the warning may delay approvals for new products targeting the U.S. market.
Source: shortlink.uk/1sCwc

4. U.S. Food and Drug Administration (US FDA) recently issued a warning to Texas medical spa after finding it used more Botox than it had officially bought. Inspectors also discovered an unlabeled vial and poor record-keeping. Authorities said the spa may have sourced products from unauthorized suppliers, raising concerns about safety and possible risks to patients receiving treatments.
Source: shortlink.uk/1nnzV

5. The Government is reportedly considering mandating that vaccines and biological products undergo batch testing exclusively at authorised government institutions such as the National Institute of Biologicals, potentially excluding private labs. The move aims to strengthen quality oversight, standardise testing, and enhance regulatory control over biologics manufacturing and release.
Source: shortlink.uk/1sCwi