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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

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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 Supreme Court has held that access to trauma care is a fundamental right under Article 21, directing all States and UTs to unify emergency helplines under 112, establish trauma registries, operationalise cashless treatment for road accident victims, and enforce ambulance tracking standards within set timelines. The ruling significantly expands constitutional obligations on healthcare infrastructure, emergency services, insurers, and public health governance across India. It also needs to have physical and digital grievance redressal systems for good samaritans. This classification is not restricted to national highways but extends to state highways and district roads too.
Source: shortlink.uk/1qB9n

2. The government has reportedly referred 27 doctors to the National Medical Commission (NMC) for disciplinary action in connection with a pharmaceutical freebies case involving sponsored foreign trips under the guise of rendering of knowledge dissemination service. The matter relates to alleged acceptance of luxury travel and hospitality benefits linked to pharmaceutical promotional activities, with State Medical Councils now expected to examine the cases pursuant to violation of MCI Code of Ethics. The development intensifies scrutiny around pharma-doctor engagement practices, and enforcement of professional conduct regulations within the healthcare sector.
Source: shortlink.uk/1vZFF

3. The Central Consumer Protection Authority (CCPA) initiated regulatory action against unauthorized online sale of hazardous chemicals like ammonium nitrate, PETN, gun powder, and picric acid. Notices were issued to e-commerce platforms, seller details shared with PESO, and platforms began delisting products to ensure consumer safety and compliance
Source: shortlink.uk/1vZFK

4. Pharmaceutical manufacturers are increasingly focusing on contamination control infrastructure, particularly Air Handling Unit (AHU) filter maintenance systems, to support compliance with revised Schedule M requirements. Industry experts note that heightened regulatory expectations around hygiene, traceability, cross-contamination prevention, and cleanroom maintenance are driving interest in automated AHU filter cleaning and maintenance technologies.
Source: shortlink.uk/1vZFU

5. Government of India is reportedly planning to launch a dedicated childhood cancer registry which aims to systematically collect data on cancer cases in children in collaboration with the Indian Council of Medical Research (ICMR). India records around seventy-five thousand new cancer cases annually, many detected late. The government plans awareness, data collection, and collaborations to improve early diagnosis and treatment outcomes.
Source: shortlink.uk/1qB8R

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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. 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

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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.

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

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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. The Department of Consumer Affairs has clarified that customary units such as inches, feet, yards and square feet may be used only as supplementary declarations alongside standard SI units under the Legal Metrology framework. The clarification aims to ensure uniformity in trade practices while preventing misleading or ambiguous quantity declarations for consumers.
Source: shortlink.uk/1vwL3

2. FSSAI plans to centralize food surveillance by separating sampling from enforcement, reducing state officers’ discretionary powers. Neutral agencies will collect samples, with results uploaded to a national database for quick alerts. This aims to enhance transparency, consistency, and consumer safety while ensuring enforcement remains with state authorities.
Source: shortlink.uk/1vwJ8

3. The Supreme Court has directed Delhi authorities to urgently frame a Standard Operating Procedure (SOP) ensuring private hospitals built on concessional government land provide free treatment to Economically Weaker Section (EWS) patients, addressing widespread non-compliance with the mandate of reserving 10% inpatient beds and 25% outpatient services.
Source: shortlink.uk/1q97l

4. The CDSCO has directed state and Union Territory drug regulators to closely monitor surrogate advertising and promotional activities related to prescription GLP-1 drugs used to treat obesity and metabolic disorders. The regulator has cautioned against indirect promotional practices, including disease-awareness campaigns and digital outreach, that could influence public demand for prescription-only medicines. The move signals intensified regulatory scrutiny of marketing, distribution, and promotion, and may also lead to stricter compliance expectations for pharmaceutical companies, digital platforms, wellness clinics, and marketers involved.
Source: shortlink.uk/1q96J

5. The Indian Council of Medical Research (“ICMR”) has introduced a single-window approval mechanism for medical research studies, replacing the earlier fragmented process requiring approvals from multiple ethics committees and institutions. The framework is intended to streamline ethics clearances, reduce procedural delays, and accelerate approvals for multicentric and collaborative research projects.
The development is significant for India’s clinical research ecosystem as it is expected to improve regulatory efficiency, transparency, and coordination in study approvals.
Source: shortlink.uk/1q96K

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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. 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. Central Drugs Standard Control Organisation (CDSCO) has issued a public notice under the Drugs and Cosmetics Act, 1940 and Cosmetics Rules, 2020, prohibiting use of cosmetics as injectable preparations by consumers, professionals, or aesthetic clinics. The notice flags four key violations: use of GNRAS or prohibited ingredients per BIS standards, misleading or false labelling claims, tampering with manufacturer inscriptions, and use of cosmetics for treatment purposes beyond their statutory scope of cleansing, beautifying, promoting attractiveness, or altering appearance.
Source: shortlink.uk/1vo9D

2. The Karnataka High Court has stayed criminal proceedings in a case involving the alleged sale of pirated books on an e-commerce marketplace, with the platform arguing that it functions solely as an intermediary and does not directly control third-party seller listings. The development brings renewed focus to intermediary liability and the extent of safe harbour protections available to e-commerce platforms under Indian laws.
Source: shortlink.uk/1vo9I

3. The High Court of Himachal Pradesh has quashed criminal proceedings against a pharma unit initiated by a Central drug inspector, holding that prosecution for manufacture, sale and distribution of drugs lies with State authorities and not the Central Government. The ruling clarifies the limits of enforcement powers of central drug regulator and may affect similar cases initiated by CDSCO against pharmaceutical manufacturers.
Source: shortlink.uk/1q0Oz

4. The Central Drugs Standard Control Organisation has reportedly initiated a review of concerns raised by retail chemists over the functioning of electronic pharmacies. Following assurances from the regulator, several state pharmacy associations have declined to participate in the proposed nationwide strike to avoid disruption in the supply of essential medicines and protect patient interests.
Source: shortlink.uk/1vo9S

5. A US federal jury found a major pharmaceutical company liable for delaying a generic version of a blockbuster constipation drug through an anticompetitive “pay-for-delay” arrangement. The verdict awarded nearly USD 885 million in damages and heightened scrutiny of delayed generic entry practices. The ruling may increase antitrust, litigation, and compliance risks for pharmaceutical companies globally.
Source: shortlink.uk/1q0OM

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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. Central Drugs Standard Control Organisation (CDSCO) has rejected a cosmetics import registration certificate and barred the importer from seeking fresh registrations for one year over alleged submission of fabricated documents under the Cosmetics Rules, 2020. The move underscores stricter regulatory scrutiny and tougher enforcement of compliance standards in India’s cosmetics import sector.
Source: shortlink.uk/1vfpf

2. India’s Punjab and Haryana High Court has upheld the conviction of a clinic owner under the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act 1994, observing that lapses in maintaining mandatory records, including Form ‘F’, cannot be treated as minor procedural defects. The Court emphasized that proper documentation is central to enforcement of the PCPNDT framework aimed at preventing female foeticide and preserving regulatory oversight of diagnostic practices. This is important as the ruling reinforces strict compliance expectations for clinics, diagnostic centres, and healthcare establishments operating under the PCPNDT regime. The judgment signals that deficiencies in statutory records may attract penal consequences even where procedural irregularities in inspection or search are alleged.
Source: shortlink.uk/1vfr5

3. Parliamentary Standing Committee has reportedly recommended expansion of Regional Raw Drug Repositories under the National Medicinal Plants Board, particularly in biodiversity-rich regions, to support documentation, authentication, conservation, and sustainable utilisation of medicinal plants used in Ayush systems. The recommendation reflects continued policy attention toward strengthening medicinal plant infrastructure and raw material quality within the herbal and phytopharmaceutical ecosystem.
Source: shortlink.uk/1pTkP

4. The Central Consumer Protection Authority (CCPA) of India has launched a probe into the online sale of an allegedly unregistered herbicide on major e-commerce platforms, citing concerns over regulatory non-compliance and inadequate product disclosures. The action underscores rising scrutiny of hazardous products sold online and may push platforms to strengthen seller verification and compliance mechanisms.
Source: shortlink.uk/1vfpx

5. The Bombay High Court held that although infringement relief was unavailable in the “OCTRIDE” and “OTIDE” dispute due to both marks being registered, passing off protection could still be granted under common law. The Court cited the marks phonetic similarity, the Plaintiff’s prior goodwill and market reputation, and the heightened risk of confusion in pharmaceutical products.
Source: shortlink.uk/1pTl0

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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 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

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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. The Central Drugs Standard Control Organization (CDSCO) has cancelled the import registration certificate of a cosmetic peel product due to non-compliance with prescribed pH tolerance limits and labelling requirements, including a “patient use” claim that did not conform to applicable Indian cosmetic labelling standards. The action reflects increased regulatory scrutiny of cosmetic product safety and labelling in India.
Source: shortlink.uk/1uZtd

2. A Parliamentary panel has recommended that the Central Drugs Standard Control Organisation (CDSCO) establish a uniform regulatory framework to address misleading advertisements relating to Ayush products, noting that the existing mechanism may result in inconsistent handling of complaints across States. The panel further observed that the absence of a standardized timeline and monitoring framework for disposal of complaints could undermine the effectiveness of the complaint reporting mechanism and potentially discourage citizens from reporting such violations.
Source: shortlink.uk/1uZth

3. The Ministry of Electronics and Information Technology has launched the Intellectual Property Catalyst initiative and digital platform to accelerate commercialization of innovations in electronics and information technology. The initiative will support patent filing, technology transfer, licensing, and industry collaboration, while enabling startups and enterprises to access indigenous technologies developed through publicly funded research.
Source: shortlink.uk/1pDUl

4. The Indian government is reportedly considering measures to regulate rising healthcare costs in private hospitals, including capping doctor consultation fees and hospital billing margins through amendments to the Clinical Establishments Act, 2010. The move aims to standardize private healthcare costs, enhance transparency, and prevent overcharging, while balancing regulatory oversight with professional autonomy in medical practice.
Source: shortlink.uk/1uZtk

5. The US Food and Drug Administration (USFDA) is reportedly exploring regulatory pathways to support the repurposing of older approved drugs for new therapeutic indications, with the aim of accelerating patient access to treatments while reducing development timelines and costs. USFDA said it is focusing on three categories of drug candidates: those with existing data supporting new uses, those showing early clinical promise, and those backed by preclinical or AI/ML-generated findings. FDA is seeking public input from patients, clinicians, public health officials, and researchers regarding priority disease areas and potential drugs for repurposing.
Source: shortlink.uk/1pDUo