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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

Posted on

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

Posted on

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 authority, FSSAI has notified the Food Safety and Standards (Vegan Foods) Amendment Regulations, 2026 which introduces revised official logo specifications for approved vegan food products, replacing the 2022 framework. Mandating the updated logo on all approved packages, the new requirements will take effect from July 1, 2027, offering businesses a transition period for packaging updates.
Source: shortlink.uk/1qVzx

2. The Department of Consumer Affairs has amended the Legal Metrology (Packaged Commodities) Rules, 2011, allowing importers to make mandatory declarations at bonded warehouses of Tier-2 and Tier-3 Authorised Economic Operators. The amendments also require disclosure of the director responsible for violations, mandate annual updates of registration details, and clarify that registration certificates will remain valid until cancelled.
Source: shortlink.uk/1qVzz

3. The Employees’ State Insurance Corporation (ESIC) has launched a centralized online patient feedback system across its hospitals and dispensaries to strengthen patient-centric healthcare delivery and improve service quality. The digital platform enables beneficiaries to submit feedback on various aspects of healthcare services, including medical care, staff behaviour, cleanliness, waiting time, and overall patient experience. The initiative aims to facilitate real-time monitoring of patient satisfaction, enhance accountability, and support timely resolution of grievances.
Source: shortlink.uk/1wkLy

4. The Delhi High Court has allowed pharmaceutical company to continue selling its cancer drug Bevatas, overturning an earlier order. The court ruled that Bevatas and Bevetex are sufficiently distinct in appearance, pronunciation and use, making consumer confusion unlikely and permitting continued sales.
Source: shortlink.uk/1wkLD

5. The National Medical Commission has issued an advisory directing all medical colleges to mandatorily implement safe injection practices, including exclusive use of sterile single-use needles and syringes, strict infection prevention measures, proper biomedical waste disposal, periodic staff training, and prompt reporting of needle-stick injuries to prevent the transmission of blood-borne infections such as HIV, Hepatitis B (HBV), and Hepatitis C (HCV).
Source: shortlink.uk/1wkLF

Posted on

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

Posted on

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 Department of Consumer Affairs met with major edible oil industry associations on 20 May 2026 to discuss standardizing pack sizes between 200 ml and 20 litres. The initiative aims to enhance consumer protection, ensure transparency in pricing, and prevent misleading packaging. Associations representing 90% of the sector supported the proposal, recommending exemptions for minor oils and packs below 200 ml, with a three month transition period for implementation.
Source: shortlink.uk/1vJbr

2. The Central Drugs Standard Control Organisation (CDSCO) has clarified that Form CT-16 applications for import of Reference Listed Drugs (RLDs) or Investigational Medicinal Products (IMPs) for export-oriented BA-BE studies may be submitted on a standalone basis through the NSWS portal. The clarification addresses operational issues due to lack of system linkage between CT-05 prior intimation applications and CT-16 applications on the SUGAM portal.
Source: shortlink.uk/1vJby

3. The Karnataka Pharma Retailers & Distributors Organization (KPRDO) has urged the government to immediately curb misleading advertisements and aggressive promotional practices relating to prescription, life-saving, and scheduled medicines, particularly across social media platforms. The organisation has also called for the creation of a specialised enforcement team and digital monitoring mechanism to address regulatory violations under the Drugs & Cosmetics Act and the Drugs & Magic Remedies Act. The recommendations could also intensify scrutiny on pharmaceutical advertising, online promotional activities, pharmacy practices, and trade compliance across the healthcare and pharma sectors.
Source: shortlink.uk/1vJbD

4. India’s central food authority has notified the Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2026, revising contaminant limits across pulses, edible oils, seafood, oilseeds, and nutmeg containing products. Updated standards cover heavy metals, aflatoxins, veterinary drug residues, and inorganic arsenic in fish oils, effective from 1 December 2026. Food businesses, seafood exporters, and nutraceutical companies must review and strengthen quality assurance systems, testing protocols, and sourcing controls to ensure compliance.
Source: FSSAI Gazette Notification, Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2026
Source: shortlink.uk/1vJbI

5. India’s Himachal Pradesh High Court has ruled that criminal liability cannot automatically be imposed on all directors or partners of a pharmaceutical company without specific averments establishing individual roles in business conduct. The judgment tightens procedural and evidentiary requirements for regulators prosecuting ‘Not of Standard Quality’ and spurious drug cases, potentially making enforcement actions under the Drugs and Cosmetics Act more legally complex for drug regulators and enforcement agencies.
Source: shortlink.uk/1vMU6

Posted on

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.

The Ministry of Health and Family Welfare has placed Pregabalin under Schedule H1 of the Drugs Rules, 1945, amid concerns over its rising misuse for sedative, euphoric, and dissociative effects, particularly among youth. The move seeks to strengthen regulatory control by restricting over-the-counter access and ensuring sale only against valid prescriptions with stricter monitoring and record-keeping requirements.
Source: shortlink.uk/1vI8d

India’s Madras High Court ruled that a mother need not undergo DNA testing to donate a kidney to her son when official records establish their biological relationship. The court set aside the transplant approval rejection and directed authorities to permit the donation immediately. This humanitarian interpretation reinforces that documentation standards should prioritise life saving procedures over rigid procedural requirements, potentially influencing future authorization committee decisions on donor recipient relationships.
Source: shortlink.uk/1vI8z

India’s central food authority is moving towards a centralised food surveillance system deploying third party agencies for sample collection, centralised laboratory testing, and digital alerts for faster regulatory action. The framework requires 50% of samples from organised supply chains. The shift signals a technology driven overhaul of food safety governance, raising compliance and traceability expectations for manufacturers, retailers, and supply chain operators.
Source: shortlink.uk/1vI8l

4. Global pharmaceutical companies are increasingly shifting high-value clinical research, regulatory, pharmacovigilance, and innovation-led functions to India as the country evolves from a low-cost outsourcing destination into a strategic global research and development hub. The shift could accelerate investments in clinical research infrastructure, advanced therapies, AI-enabled drug development, and specialised talent while strengthening India’s competitiveness as a global life sciences and biotech hub.
Source: shortlink.uk/1qk9u

5. The Competition Commission of India (CCI) has rejected allegations of monopoly and excessive pricing against 12 private hospitals in Delhi, ruling that higher prices alone do not prove abuse of dominance. The regulator found hospitals operated within competition norms, allowed external procurement, and charged within MRP, dismissing decade-long complaints.
Source: shortlink.uk/1vI8q

Posted on

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

Posted on

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 drug licensing authority (“CDSCO”) has issued a detailed FAQ document clarifying procedural and compliance requirements relating to prior intimation for Bioavailability (BA) and Bioequivalence (BE) studies for drugs meant for export purposes, under the amended provisions introduced through a notification. The guidance addresses limitations, submission timelines, documentation expectations, and regulatory processes for study sponsors and contract research organisations.
Source: shortlink.uk/1pHxP

2. The Central Drugs Standard Control Organisation (CDSCO) is reportedly working on regulatory guidelines for the use of high-risk solvents amid concerns over Propylene Glycol and its toxic impurities, Diethylene Glycol (DEG) and Ethylene Glycol (EG), in paediatric oral medicines like cough syrups. The move aims to strengthen quality checks, improve ingredient oversight, and prevent future contamination-related public health incidents.
Source: shortlink.uk/1v3ev

3. The Karnataka High Court has stayed the FSSAI advisory restricting the use of Ashwagandha leaves and leaf extracts in health supplements, providing interim relief to nutraceutical and wellness companies using such ingredients in their products. The Court observed that such restrictions may require amendments instead of being introduced through an advisory mechanism alone. This is important as the advisory had created restrictions for manufacturers operating in the nutraceutical and Ayush sectors using Ashwagandha. The order temporarily allows continued use of Ashwagandha leaf extracts while the larger regulatory and legal validity of the restriction is examined.
Source: shortlink.uk/1v3eB

4. India’s drug regulator has directed all 4,153 licensed blood banks to register on ONDLS portal on priority, as part of HIV infections in children due to contaminated transfusions linked to unsafe transfusions. Every blood center must register itself regardless of the status of their license.
Source: shortlink.uk/1v3eQ

5. The European Union has included India in its revised draft list allowing continued export of Indian aquaculture products from September 2026, bringing major relief to India’s seafood industry after the country’s earlier exclusion in 2024. The decision follows India’s compliance with European food safety and antimicrobial regulations.
Source: shortlink.uk/1v3eW