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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 advised stakeholders to submit clinical trial protocols simultaneously to CDSCO and Ethics Committees under Chapter III of the New Drugs and Clinical Trial Rules, 2019. This is important as it aims to reduce approval timelines and improve regulatory efficiency, enabling faster initiation of clinical trials and quicker patient access to innovative therapies.
Source: shortlink.uk/1pAw-

2. The Parliamentary Panel on Health and Family Welfare has reportedly urged the Ministry of AYUSH to strengthen international cooperation by prioritising partner countries for joint research, clinical studies, academic exchanges and capacity building in traditional medicine. The panel also recommended improving the Ayush Global Portal for better accessibility and global engagement. it could improve scientific validation, expand international acceptance of Ayurveda and yoga, and enhance India’s global influence in healthcare.
Source: shortlink.uk/1pAx1

3. The Food Safety and Standards Authority of India has reportedly issued a show-cause notice to a clean label food brand over claims that its chocolates contain “no added sugar” despite using dates and date powder as sweeteners. The action follows complaints by a rival brand and raises questions over compliance with FSSAI’s rules over claiming “non-addition of sugars”. The dispute could influence how food companies market sugar-free or no-added-sugar products in India’s growing chocolate sector.
Source: shortlink.uk/1uVZF

4. Private hospital associations have raised concerns over CGHS reimbursement caps, warning that limiting payouts to 70% of MRP for high-cost immunotherapy drugs may hinder access to advanced cancer care. This is important as this could increase patient costs, restrict use of costly treatments, and strain hospitals’ ability to provide life-saving oncology therapies.
Source: shortlink.uk/1pAx9

5. A lawsuit filed in California has raised concerns around AI-generated health and substance-use advice after allegations that chatbot interactions contributed to a teenager’s fatal overdose. The suit reportedly alleges that unsafe guidance on drug combinations was provided without adequate safeguards or warnings. The matter reflects growing regulatory oversight for AI tools used in healthcare, mental health, and wellness contexts.
Source: shortlink.uk/1pAxb

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 Organisation (CDSCO) has issued an advisory directing manufacturers and importers to submit Periodic Safety Update Reports (PSURs) from the actual marketing date of new drugs, not approval date. The regulator also mandated consolidated PSUR submissions covering all dosage forms and indications to prevent duplication and improve post-marketing safety monitoring. This is important because accurate PSUR timelines strengthen drug safety surveillance and help regulators detect adverse effects more effectively.
Source: shortlink.uk/1uTal

2. India’s central drug licensing authority has reportedly directed states to intensify action against the illegal sale and misuse of sexual enhancement drugs such as sildenafil, varde¬na¬fil and tadalafil, citing public safety and social concerns. The regulator has ordered raids against illegal clinics, pharmacies, and online platforms, alongside stricter monitoring, awareness measures, and legislative action to curb unauthorized sales without prescriptions.
Source: shortlink.uk/1uTas

3. The Delhi High Court granted interim relief in a trademark and copyright dispute concerning sexual wellness products marketed under the “Stand Up” branding. The Court found the competing packaging and labels deceptively similar and ordered removal of online listings, while restraining further use of the disputed branding pending adjudication.
Source: shortlink.uk/1uTax

4. The Delhi Commercial Court has granted a permanent injunction restraining the defendants from manufacturing, selling, or dealing in cosmetics under the deceptively similar “ROOP LADY” trademark and sindoor bottle design, holding that the defendants had no proprietary rights over the impugned mark/design and that their activities amounted to trademark infringement, design piracy, copyright infringement, and passing off. This is important as the ruling reinforces judicial protection of intellectual property rights in the cosmetics and personal care sector, particularly against counterfeit and deceptively similar products that may mislead consumers and dilute brand goodwill.
Source: shortlink.uk/1pxNP

5. Maharashtra’s State Blood Transfusion Council (SBTC) has reportedly launched stricter oversight of blood banks following reports of profiteering through the sale of excess plasma at inflated rates. The council has introduced a 50-point inspection checklist and warned against over-collection and unauthorized plasma transfers, aiming to strengthen ethical blood banking practices and patient safety.
Source: shortlink.uk/1uTaS

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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 pharmaceutical industry has strengthened its position as the “Pharmacy of the World”, exporting affordable medicines and vaccines to more than 200 countries. The sector now earns over half its revenue from exports, supplies vaccine demand, and is expected to reach 130 billion dollars value by 2030.
Source: shortlink.uk/1uSYh

2. The All India Institute of Medical Sciences (AIIMS), New Delhi has introduced India’s first portable bedside MRI system for critically ill patients in ICUs and emergency settings. This is significant as it enables rapid brain imaging without shifting unstable patients, improving timely diagnosis, monitoring, and critical care outcomes.
Source: shortlink.uk/1uSYo

3. India’s Directorate General of Health Services has introduced its first comprehensive framework for Intensive Care Units (ICUs), laying down standardized norms. ICUs have been categorised into 3 levels, with each level prescribed minimum bed strength, infrastructure and equipment requirements, staffing ratios, and specialist qualifications.
Source: shortlink.uk/1pxBR

4. The Food Safety and Standards Authority of India (FSSAI) seized misbranded “alkaline water” products for alleged use of non-permitted ingredients and labelling violations, signalling increased scrutiny of functional and packaged drinking water products in the west region. The action highlights growing regulatory focus on misleading health claims, ingredient disclosures, and compliance with Indian food safety and labelling laws.
Source: shortlink.uk/1uSYx

5. The Union Health Ministry has launched JANANI (Journey of Antenatal, Natal and Neonatal Integrated Care), a QR-enabled digital platform aimed at strengthening maternal and child healthcare through longitudinal digital health records. The platform will track antenatal care, delivery, postnatal care, newborn care, and family planning services. The initiative is significant as it seeks to improve continuity of care, enable real-time monitoring of high-risk pregnancies, and strengthen technology-enabled public healthcare delivery across India.
Source: shortlink.uk/1uSYA

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. A pharmaceutical company has paused its obesity awareness campaign in India following an advisory from CDSCO against surrogate promotions that may indirectly lead consumers to a medicine, which is prohibited across media platforms. This is important as Indian regulators are increasingly monitoring disease-awareness and indirect promotional campaigns to ensure adherence to drug advertising, particularly in rapidly growing therapy areas such as obesity management. Going forward, pharmaceutical and healthcare companies may face tighter scrutiny over patient awareness initiatives, digital outreach, and indirect marketing strategies, requiring stronger alignment with India’s evolving compliance and promotional framework.
Source: shortlink.uk/1uSTv

2. Manufacturers of platinum-based cancer medicines have reportedly urged the NPPA to revise the ceiling prices of regulated chemotherapy drugs such as cisplatin, carboplatin, and oxaliplatin after platinum API costs surged by nearly 200%–300%, making production commercially unviable. The industry warned that unchanged price caps could disrupt supplies of essential cancer medicines and adversely impact patient access to critical treatments.
Source: shortlink.uk/1pxx5

3. Pharmaceutical exporters continue to face delays in obtaining World Health Organization Good Manufacturing Practices Certificates (WHO-GMP) of Pharmaceutical Products through the Online National Drug Licensing System portal. Industry bodies warned that technical glitches and processing delays are disrupting exports and international regulatory commitments.
Source: shortlink.uk/1uSTF

4. The Uttarakhand High Court granted bail to a snake venom collector accused of illegally possessing venomous snakes and extracted venom. The court noted his licence had expired and renewal was pending, suggesting procedural lapses rather than deliberate wildlife trafficking. The case highlights regulatory and compliance sensitivities surrounding wildlife-derived substances used in research and pharmaceutical applications.
Source: shortlink.uk/1uSTJ

5. Singapore’s Health Sciences Authority (HSA), participating in INTERPOL’s Operation Pangea XVIII, removed 959 illegal online health product listings and seized 6,641 units of unregistered medicines and medical devices at borders. Operation Pangea XVIII is a coordinated enforcement drive across 90 countries targeting illegal and counterfeit health products. The crackdown targeted products including contact lenses, ivermectin, dermal fillers, and prescription medicines. HSA also warned 152 sellers and cautioned consumers against purchasing illegal or self-administered health products online due to serious safety risks.
Source: shortlink.uk/1uSTM

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 Government of India is considering capping billing margins charged by private hospitals on medical devices to curb overcharging and reduce treatment costs. This is important as excessive markups increase patient expenses and insurance premiums. If implemented, it will limit hospital margins, improving pricing transparency and affordability.
Source: shortlink.uk/1olUB

2. The Central Government has established the Online Gaming Authority of India (OGAI), with effect from May 1, 2026, under the Promotion and Regulation of Online Gaming Act, 2025, to regulate the gaming sector. Operating under MeitY, this multi-sectoral authority will oversee licensing, mandate registration for esports, and enforce stringent compliance requirements, with a view to enhancing user safety and strengthening regulatory oversight of online gaming.
Source: shortlink.uk/1tDQe

3. Indias central drug ministry has proposed amendment to Drugs Rules 1945 by expanding the list of licences that may be exempted from requiring a Form 29 licence for manufacturing of drugs for test or analysis. The amendment proposes to include Forms 25A (loan licences), 25F (Schedule X drugs), 28A/28B (Schedule C, C(1), and X drugs), 28D/28DA (vaccines, sera, r-DNA drugs), and 28F (umbilical cord blood stem cells). Objections and suggestions from the industry will be considered for thirty days.
Source: shortlink.uk/1tDQk

4. The Delhi High Court has restrained the use of the trademark “MARQ,” finding it deceptively similar to “MARC” and likely to confuse consumers. This reinforces trademark protection by emphasizing that minor spelling differences, use of house marks, or later registrations do not override prior rights and established goodwill.
Source: shortlink.uk/1tDQs

5. Government of India plans a Health Claims Index to transparency and standardize pricing in India health insurance sector. Using anonymized data from the National Health Claims Exchange, it will benchmark claims timelines, approvals and costs, enabling underwriting, reducing inefficiencies, and supporting informed consumer decisions, subject to scale and execution.
Source: shortlink.uk/1olUW

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

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. Regulatory reforms under the Biological Diversity Amendment Act, 2023 are driving increased intellectual property filings linked to India’s biological resources. Streamlined procedures and mandatory prior registration with the National Biodiversity Authority have enhanced compliance, improved processing efficiency, and strengthened alignment between innovation, conservation priorities, and equitable benefit sharing frameworks
Source: shortlink.uk/1nbX2

2. The Jammu & Kashmir and Ladakh High Court has ruled that merely holding the position of Director or Managing Director does not automatically attract liability under the Drugs and Cosmetics Act, 1940. Liability arises only if specific allegations prove the individual was responsible for the company’s conduct or involved in the offence.
Source: shortlink.uk/1sqvC

3. The Drugs Consultative Committee(DCC) has approved a proposal to develop a real-time digital portal for tracking manufacture, import, export, sale, and stock of pharmaceutical products regulated under the Narcotic Drugs and Psychotropic Substances Act. The portal is aimed at strengthening surveillance, with potential integration involving CDSCO, State Authorities, and the Central Bureau of Narcotics.
Source: shortlink.uk/1nbXc

4. The Department of Pharmaceuticals has liberalised the RPTUAS guidelines to allow shortlisted applicants to claim the first instalment of subsidy upon submission of either a Revised Schedule M or WHO-GMP certificate. The remaining certificate may be furnished at the time of claiming the second instalment, thereby providing greater flexibility in meeting compliance requirements.
Source: shortlink.uk/1nb-y

5. India’s Directorate General of Foreign Trade expanded the mandatory Halal certification requirement under the India Conformity Assessment Scheme (I CAS) Halal to 20 additional countries, including Egypt, Kenya, Morocco, and Maldives. Exporters must obtain certification from NABCB-accredited bodies, with compliance effective within two weeks (six months for Egypt).
Source: shortlink.uk/1sqvW

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 Delhi High Court ruled that India’s central food authority, Food Safety and Standards Authority of India (FSSAI) cannot regulate animal or cattle feed under the Food Safety and Standards Act, 2006, holding that the law is limited to food meant for human consumption. The Court quashed FSSAI regulations restricting use of meat and bone meal in feed for milk- and meat-producing animals, citing lack of statutory authority.
Source: shortlink.uk/1sjFt

2. Telangana Health Minister has reportedly declared cancer a notifiable disease and launched a cancer registry to improve surveillance and care. With thousands of new cases, the initiative aims to strengthen data driven planning, expand treatment infrastructure, and introduce artificial intelligence based screening across government hospitals.
Source: shortlink.uk/1n5jM

3. The Drugs Technical Advisory Board has decided not to pursue the proposal to mandate pharmaceutical companies to allocate at least 1 percent of net profits towards free medicines under Corporate Social Responsibility (CSR). The decision follows clarification that CSR obligations fall under the Companies Act, 2013 and not under Drugs and Cosmetics Act and Rules made thereunder.
Source: shortlink.uk/1n5jP

4. The Directorate General of Foreign Trade (DGFT) of India, has permitted export of an additional 5 lakh metric tonnes of wheat flour and related products under HS Code 1101, while maintaining the “prohibited” export status. This quota comes over and above the 5 LMT allowed in January 2026, with detailed export modalities to be notified separately.
Source: shortlink.uk/1sjGG

5. The Court granted an ex parte ad interim injunction restraining the use of the mark “HIMALAYA THE NUTRA HEALTH CARE”, holding it to be deceptively similar to the plaintiff’s registered trademarks and trade dress. The Court noted the plaintiff’s long-standing presence, and global operations, and found that the impugned mark was likely to cause consumer confusion, constituting prima facie infringement
Source: shortlink.uk/1sjFF

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 Delhi High Court granted interim relief to Pharmaceutical company by restraining other pharmaceutical company from using “ALKAKIND” or similar marks. The Court held that the “KIND” suffix has acquired distinctiveness through extensive use, creating a strong likelihood of consumer confusion and reinforcing trademark protection for established pharma brands.
Source: shortlink.uk/1n47Q

2. The Government of India has issued the Safety of Household, Commercial and Similar Electrical Appliances (Quality Control) Order, 2026, making BIS certification mandatory for 90 categories of electrical appliances. It will come into force on 1 October 2026, with phased timelines for MSMEs. Non-compliance will attract penalties under the BIS Act, 2016.
Source: shortlink.uk/1n48h

3. Indian pharma manufacturers have reportedly urged the National Pharmaceutical Pricing Authority of India to approve up to a 50% price increase for platinum-based chemotherapy drugs such as carboplatin, cisplatin, and oxaliplatin, after platinum prices nearly doubled from ₹3,869 to ₹8,000 per gram in six months, making production financially unviable and risking supply disruptions.
Source: shortlink.uk/1n48q

4. The Drug Technical Advisory Board (DTAB) has proposed extending PSUR timelines under the New Drugs and Clinical Trials Rules, 2019 for modified or sustained release drugs, novel drug delivery systems, and advanced biologics across their lifecycle, with annual and triennial reporting beyond four years. Currently, PSURs are submitted semi-annually for two years and annually thereafter.
Source: shortlink.uk/1sisG

5. India’s affordable generic medicines under the Jan Aushadhi scheme may see price increases as shipping disruptions linked to the West Asia conflict have raised raw material costs and constrained supply. The supply crunch is affecting local manufacturing, with smaller pharma units facing margin pressure, potentially impacting availability of low-cost medicines across Jan Aushadhi Kendras.
Source: shortlink.uk/1n48A