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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. 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

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 Food Safety and Standards Authority of India has issued an advisory directing food businesses to avoid the use of Ashwagandha (Withania somnifera) leaves in crude, extract, or any other form in food products. This is important as Ashwagandha is widely used in nutraceutical and functional food formulations, signalling tighter scrutiny on botanical ingredients. Companies may now need to review formulations and ensure regulatory compliance.
Source: shortlink.uk/1tzwL

2. The Delhi District Consumer Disputes Redressal Commission issued a non-bailable warrant against the managing director of a multinational fast food company, for failing to comply with a November 2024 order to discontinue levying packing charges, pay compensation for unfair trade practices, and repeated non-appearance. This is important as it signals stricter enforcement of consumer rulings and increased personal accountability of senior leadership.
Source: shortlink.uk/1tzwQ

3. Pharmaceutical traders have opposed draft amendments to the Medical Devices Rules, 2017, mandating disclosure of sterilization site licence numbers on labels and revising testing fees. The industry warns this may restrict vendor flexibility, delay supplies, and increase compliance burden, particularly impacting SMEs and overall supply chain efficiency.
Source: shortlink.uk/1ohJu

4. The Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 requiring manufacturers to include sterilization site licence numbers on labels when sterilization is outsourced, along with revised testing and annual fees, prompting concerns from industry stakeholders. This is important as the changes may increase compliance costs and disrupt supply chains. Companies may need to redesign labels, reassess vendors, and adjust operations.
Source: shortlink.uk/1tzwY

5. National Comprehensive Cancer Network has updated global breast cancer screening guidelines to include image-based AI risk assessment using mammograms, recommending risk evaluation starting at age 35 to enable personalized screening strategies. This shifts screening from detection to early risk prediction, enabling earlier intervention. Healthcare providers may now adopt AI-based tools and adjust screening protocols.
Source: shortlink.uk/1tzx8

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. Bombay High Court restrained use of the mark Esiraft, finding it deceptively similar to an existing registered trademark Raciraft and likely to cause consumer confusion. The ruling reinforces strict standards on phonetic and visual similarity, strengthening protection against trademark infringement and passing off in the pharmaceutical sector.
Source: shortlink.uk/1sTZo

2. The U.S. Food and Drug Administration (USFDA) has released draft guidance on using next-generation sequencing (NGS) to assess gene therapy safety, detecting off-target edits, evaluating insertional mutagenesis, assessing vector integration sites, and ensuring genomic integrity. This is important as it strengthens detection of unintended genetic changes. If finalized, developers must adopt validated NGS methods and enhanced data reporting in IND submissions.
Source: shortlink.uk/1sTZq

3. The Food Safety and Standards Authority of India (FSSAI) has introduced flexibility in payment timing for visual inspection and laboratory testing charges under the FICS/SWIFT system, allowing importers to make payments after inspection instead of upfront. This is important as the move improves cash-flow management, reduces clearance delays, and enhances ease of doing business. Importers should now align internal payment and clearance workflows to leverage the revised process and avoid procedural bottlenecks.
Source: shortlink.uk/1sTZu

4. The U.S. Food and Drug Administration issued a warning to a major medical supply manufacturer over defective angiographic syringes used in heart procedures following multiple complaints related to device disconnections and potential patient and clinician safety risks. The company recalled the syringes in March 2026 but the FDA warned that failure to address the violations could result ‌in seizure of products, court action or financial penalties.
Source: shortlink.uk/1nEv0

5. The U.S. Food and Drug Administration has asked a weight-loss drug giant manufacturing giant to submit additional safety data for its newly approved oral weight-loss pill, including post-marketing studies on liver injury, cardiovascular risks, delayed gastric emptying, and drug presence in breast milk. This highlights tightening of post-market surveillance scrutiny, and evolving safety requirements for next-generation weight-loss therapies.
Source: shortlink.uk/1sTZz