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. The Central Drugs Standard Control Organization has directed state regulators to strengthen enforcement against the use of Chloramphenicol and Nitrofurans in food-producing animals. The move follows continued detection of these substances in export consignments, leading to international rejections and raising concerns over regulatory compliance and export competitiveness.
Source: shortlink.uk/1wKBT

2. The Food Safety and Standards Authority of India (FSSAI) has notified the Food Safety and Standards (Prohibition and Restrictions on Sales) Amendment Regulations, 2026, which came into force upon publication in the Official Gazette on 23 May 2026. Through the amendment, FSSAI has omitted clause (8) of sub-regulation 2.3.14 of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, following consideration of stakeholder comments received on the draft regulations issued in October 2024. The amendment formally revises the existing regulatory framework governing restrictions on the sale of specified food products under the Food Safety and Standards Act, 2006.
Source: shortlink.uk/1wKCp

3. The US FDA has launched a safety study of the abortion pill, also called mifepristone, potentially enabling new restrictions on its distribution and use. The FDA has further said for mifepristone to be safe and effective. Officials say the review is already underway and science based. The study will analyse existing data and could influence abortion access policies. Abortion right was legalised through the Supreme Court’s 2022 ruling which overturned Roe v. Wade.
Source: shortlink.uk/1rjC6

4. A pharmaceutical manufacturer has received a Warning Letter from the United States Food and Drug Administration (USFDA) concerning its formulation manufacturing facility in Baddi, Himachal Pradesh. The regulatory action was issued following a review of records submitted under the US Federal Food, Drug, and Cosmetic Act and is not linked to any on-site inspection of the facility. The observations relate to the use of purified talc that did not meet the current United States Pharmacopeia (USP) requirements. The company has stated that the Warning Letter is not expected to impact ongoing operations or product supplies from the facility and has committed to undertaking the necessary corrective actions and responding to the USFDA within the prescribed timelines. The facility was last inspected by the USFDA in August 2025 and subsequently received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) classification.
Source: shortlink.uk/1wKCB

5. Hospitals across India are reportedly facing shortages of key chemotherapy drugs, including cisplatin and carboplatin, disrupting cancer treatment schedules and forcing patients to search for alternative supplies. The shortage has been linked to supply chain constraints and rising input costs, raising concerns about continuity of care and treatment outcomes.
Source: shortlink.uk/1wKCH

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. India’s central health ministry has notified the revised fees for testing or analysis for drugs, vaccines, and AYUSH medicines given under Schedules B and B(1) of the Drugs Rules, 1945. The revised fees will be applicable in three months post-publication in official gazette. The fees shall automatically increase by 5% annually. For the tests that are not listed in the Schedule, charges will be determined by the Director or the Government Analyst of the Laboratory or institute. This update will focus on strengthening India’s testing infrastructure while increasing compliance expenses for manufacturers.
Source: shortlink.uk/1qPI3

2. The Delhi High Court dismissed the appeal challenging exclusive rights in the mark“REDDY” for pharmaceutical goods, affirming cancellation of a conflicting registration and restraining its continued use. The ruling reinforces the importance of acquired distinctiveness, market reputation, and consumer protection in trademark enforcement within regulated industries.
Source: shortlink.uk/1weId

3. This official corrigendum by India’s NPPA, dated May 27, 2026, corrects the manufacturer and brand names under serial number 4 of Table-B in its previous Ringer Lactate ceiling price order (S.O. 1584(E)) (p. 2). The manufacturer is now M/s Fresenius Kabi India, with brands ‘Freeflex bags’ and ‘Eurohead bottle’ (p. 2).
Source: shortlink.uk/1qPID

4. National Pharmaceutical Pricing Authority may reportedly refer the methodology for fixing ceiling prices of intravenous (IV) fluids to its Multi-Disciplinary Committee (MDC) of experts after identifying inconsistencies in pricing across formulations and special-feature packaging. The review will improve transparency and consistency in the pricing of IV fluids while addressing concerns over packaging-related pricing variations.
Source: shortlink.uk/1weIH

5. The Food Safety and Standards Authority of India (FSSAI) has sought an explanation from a leading quick commerce platform following a consumer complaint alleging illness after consuming curd purchased through the platform. The regulator has reportedly requested a detailed Action Taken Report (ATR) and sought information regarding food safety compliance, while noting multiple recent complaints relating to allegedly spoiled, unhygienic, or damaged food products sold through the platform’s marketplace sellers. The development underscores increasing regulatory scrutiny of food safety obligations in the e-commerce and quick commerce sector, particularly concerning platform accountability for products sold by third-party sellers.
Source: shortlink.uk/1weIQ

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 National Health Authority is developing a national artificial intelligence policy for healthcare to guide wider use of technology to address health challenges including diagnostics, public health programmes, and digital health platforms. This will be a major shift toward structured, large-scale adoption of technology in India’s health system. It can improve access, efficiency, and data-driven decision-making across public healthcare delivery.
Source: shortlink.uk/1tzfD

2. India’s Central government has directed states to uniformise package rates for common medical procedures, adopt uniform treatment guidelines, and implement digital claims processing through the National Health Claims Exchange to improve billing transparency and reduce pricing variations across private hospitals. These disparities have been identified in driving higher insurance premiums and affecting affordability.
Source: shortlink.uk/1ohsz

3. The Bombay High Court delivered a judgment after scrutinising enforcement under the Drugs (Prices Control) Order (DPCO), holding that overcharging determinations and recovery demands must strictly adhere to statutory methodology, including correct price fixation, computation, and grant of hearing. Finding procedural infirmities and inadequate reasoning, the Court set aside the demand and directed fresh adjudication, reinforcing due process and curbing arbitrary.
Source: shortlink.uk/1tzfM

4. The Central Drugs Standard Control Organization (CDSCO) has issued a regulatory communication outlining updated requirements related to drug approvals, compliance, and regulatory submissions for industry stakeholders. This is important as increased regulatory scrutiny may impact approval timelines and documentation standards. Companies may now need to review regulatory submissions, strengthen compliance processes, and align product lifecycle strategies with evolving CDSCO expectations.
Source: shortlink.uk/1tzfQ

5. The Drugs Technical Advisory Board has approved a proposal to amend the Medical Devices Rules, 2017 to introduce a definition of reportable events and mandate adverse event reporting, including for in-vitro diagnostic devices. This is important as it strengthens post-market surveillance and device safety oversight. Manufacturers and importers may now need enhanced reporting systems and tighter compliance processes.
Source: shortlink.uk/1ohsK

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. Indonesia’s health ministry has directed food companies to introduce coloured labels indicating nutritional content, within two years. Red and green labels will indicate high and low sugar, salt, and fat content respectively. Companies must revise packaging and validate nutritional content to meet the new labelling requirements, but detailed sanctions for non-compliance have not been informed yet.
Source: shortlink.uk/1nEyC

2. Gujarat Food and Drug Control Administration has reportedly directed all ayurvedic medicine manufacturers to register on the ayudmla.gujarat.gov.in portal and upload complete legacy records, mandating digital compliance for licensing processes across the state. It strengthens regulatory oversight and promotes digital compliance in the ayurvedic sector.
Source: shortlink.uk/1sU3e

3. The Bangalore District Chemists and Druggists Association and other retail pharmacy groups have urged regulators to mandate licensing requirements for e-pharmacies displaying medicines online, similar to physical stores under the Drugs and Cosmetics Act, 1940. This is important as it highlights growing concerns around patient safety, regulatory gaps, and unfair competition. If implemented, e-pharmacy platforms may face stricter compliance, licensing requirements, and potential changes to their marketplace and digital medicine distribution models.
Source: shortlink.uk/1sU3h

4. A leading weight loss drug manufacturer has partnered with OpenAI to deploy artificial intelligence across drug discovery, manufacturing, and operations, while training its workforce globally. The initiative will help to enhance productivity, strengthen competitive positioning in the obesity therapeutics market, and improve overall efficiency without immediate workforce reductions.
Source: shortlink.uk/1nEyI

5. The Bangalore District Chemists and Druggists Association and other retail pharmacy groups have urged regulators to extend licensing norms for medicine display to e-pharmacies, seeking clarity on “offer for sale” under the Drugs and Cosmetics Act. This is important to curb unlicensed digital sales and ensure parity, potentially bringing online platforms under stricter licensing and compliance requirements.
Source: shortlink.uk/1sU3l

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Supreme Court ruled that mixing samples collected from contraband contained in various packages after a seizure violates the terms of the Narcotic Substances and Psychotropic Substances Act and the rules enacted under it. The court noted that the statutory rules require a specific procedure to be followed, and the Detecting Officer is obligated to follow the authorized procedure. No one can presume the nature of the substance based on speculations and conjectures.
Source: bit.ly/3zN4yV9

2. The Central Consumer Protection Authority fined a firm selling ayurvedic oil ₹ 10 lakh for violating consumer protection laws on misleading advertisements which claimed relief from joint pain without surgery or physiotherapy while promoting their joint-pain-relieving product.
Source: bit.ly/3W1YJum

3. Following the Central Government’s decision to replace British-era criminal procedure codes with Bharatiya Sanhitas, the Government of India held a meeting with the Drugs Control Officers (India) Welfare Association (DCO India) to change the name of the Drugs and Cosmetics Act, 1940, passed by the British Rulers to ‘Bharatiya Aushadhi awam Chikitsa Upakaran Adhiniyam’. The national conference of Indian drug regulators will hold in-depth discussions on the subject.
Source: bit.ly/3WphadL

4. The National Health Authority (NHA) and the Insurance Regulatory and Development Authority of India (IRDAI) collaborated to launch the National Health Claim Exchange (NHCX), a digital platform for exchanging insurance claims-related information among healthcare and insurance stakeholders. The NHCX will enable seamless interoperability of health claims processing, allowing citizens to track their insurance claim progress via mobile devices.
Source: bit.ly/3xQ9EPX

5. The US Food and Drug Administration (FDA) issued final question-and-answer guidance outlining how it assesses user fees for combination products, as well as the various programs available to sponsors for requesting user fee waivers under the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Amendments (MDUFA). The guideline offers background information on combination goods, how the agency calculates user fees for single and multiple applications, and how to request waivers or reductions in user costs.
Source: bit.ly/3y3roHw