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. A major food manufactured in the USA has removed all certified artificial colours from its food and beverage portfolio successfully, achieving its goal of fully eliminating them by the middle of this year. This move was announced in June 2025 and was confirmed that more than 90% of its U.S. portfolio was already free from synthetic dyes. These reformulated products have started arriving for consumption in the USA.
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2. Hong Kong’s Department of Health has announced that medical gases will be regulated as pharmaceutical products from June 14, 2026, requiring manufacturers, wholesalers, and retailers to obtain relevant licences. Products containing nitrous oxide and nitric oxide will be classified as prescription medicines. Non-compliance may result in fines, imprisonment, and other regulatory enforcement actions.
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3. The U.S. Food and Drug Administration (FDA) has issued warning letters to multiple entities for alleged violations of current Good Manufacturing Practice (CGMP) requirements and for the unlawful marketing of GLP-1 receptor agonist drugs through telehealth platforms. These warnings address firms that do not meet quality standards and telehealth providers promoting unapproved products for weight loss. The FDA emphasised compliance with manufacturing, quality, and marketing rules, and cautioned that failure to address the identified violations could result in further regulatory action.
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4. India’s Central government has amended the marine export laws for export administration, effective from 9th June 2026. To modernize export administration, the notification mandates online registration workflows and establishes revised fee schedules. The legislative intent is to digitize statutory record-keeping and enforce strict compliance protocols governing ownership transfers, facility modifications, and dealer licensing across vessels, processing plants, and storage premises.
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5. The World Health Organization has urged countries to shift from visual inspection and cytology-based screening to Human Papillomavirus testing for cervical cancer prevention. The updated recommendation highlights superior accuracy in detecting high-risk infections and supports wider adoption of affordable, locally developed Human Papillomavirus tests to accelerate cervical cancer elimination efforts.
Source: short-url.cc/1xs6P

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. USA based company has issued a nationwide recall of its powdered infant formula after the FDA and CDC contacted the company about three infant botulism cases involving babies who had consumed its formula. The affected infants in California, Washington, and Pennsylvania were hospitalized and treated with FDA-approved treatment, with no deaths reported. No formula has tested positive for the bacteria; the recall was made as a precaution.
Source: short-url.cc/1rUTh

2. The Union Health Ministry’s decision to remove cough syrups from the Schedule K exemption may encourage a shift towards Ayurveda, Siddha and Unani remedies, particularly in rural areas where access to doctors and licensed pharmacies is limited. Industry experts expect demand for Ayush cough syrups to rise as access to conventional cough syrups require a prescription for purchase.
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3. IHLD MedTech to reportedly establish a nationwide network of specialized wound-care Centers of Excellence under its Wound Heal Plus initiative. This is important as chronic and non-healing wounds, particularly among diabetic patients, remain a major healthcare challenge. The network will expand access to advanced wound management, rehabilitation, and AI-enabled patient monitoring services.
Source: short-url.cc/1rUTw

4. US FDA has approved updated safety labelling for an OTC weight-loss drug, adding warnings about rare risks of acute kidney injury and kidney stones. The change is important as it alerts consumers and healthcare providers to potential kidney complications, especially among users with kidney disease or a history of kidney stones.
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5. A recent inspection by the Telangana Medical Council has reignited discussions on the scope of practice and legality of dentists in relation to aesthetic and hair transplantation procedures. The NMC stated that only trained medical professionals should conduct these non-emergency procedures. The NDC allowed oral and maxillofacial surgeons to perform them with proper training. Furthermore, the Telangana Medical Council confirmed that dentists lack the training for such procedures.
 Source: short-url.cc/1xn6U

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. Maharashtra FDA Commissioner Tukaram Mundhe issued an Order on June 12, 2026 barring hospitals, doctors, and affiliated pharmacies from compelling patients to buy medicines exclusively from in-house pharmacies. Prescriptions must be handed directly to patients which gives the patients an option to pick pharmacy of their choice. This restriction put by hospitals on the choice of the patient to purchase medicines from their choice of a pharmacy amounts to unfair trade practices under the Consumer Protection Act, 2019. Further, hospitals must now display notices stating patients of their right to purchase medicines from any licensed pharmacy of their choice in English and Marathi.
Source: shortlink.uk/1xhAz

2. The Jharkhand High Court has directed a complete ban on the conduct of the “two-finger test” in all hospitals, medical colleges, and healthcare institutions across the State. Reiterating established legal and medical principles, the Court observed that the practice is unscientific, violates the dignity, privacy, and bodily autonomy of survivors of sexual assault, and has no evidentiary value in determining consent or sexual history. The Court directed the concerned authorities to ensure strict compliance with existing guidelines and legal standards governing the medical examination of sexual assault survivors, while emphasizing the need for survivor-centric and trauma-informed medical care. The ruling reinforces the prohibition on the use of the test and underscores the obligation of healthcare institutions to adhere to prescribed medico-legal protocols.
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3. The Telangana Drugs Control Administration has reportedly intensified enforcement against illegal medicine distribution by raiding an unauthorized supplier of cardiac stimulant injections and an unlicensed medical shop. Authorities warned against unauthorized sales and supply of prescription medicines.
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4. The Supreme Court has reaffirmed that strict compliance with the PCPNDT Act, 1994 is essential to prevent sex-selective practices and female foeticide. The Court held that deficiencies in mandatory records, including Form F, are not mere technical errors but substantive violations. Emphasising the Act’s objective, it observed that accurate documentation is a crucial safeguard for effective monitoring, enforcement, and prevention of unlawful sex determination practices.
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5.India’s Ministry of Health and Family Welfare has notified an amendment to Drugs Rules, 1945 dated June 9, 2026. The amendment removes the term “Syrups” from Item (7) under Serial No. 13 of Schedule K of the Drugs Rules, 1945. This means that now syrups will be sold under a sales license only. Schedule K specifies certain classes of drugs and categories of persons or institutions that are exempt from specific provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder, subject to prescribed conditions. The amendment came into force on the date of its publication in the Official Gazette.
Source: shortlink.uk/1rOqd

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.
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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
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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

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

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

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

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