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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

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. India’s Medical Device Regulator has proposed standardising testing fees at government laboratory by notifying fixed charges under a new schedule. There was no regulation on cost of testing fees from government labs, and small and medium scale medical device manufacturers who actually avail services of external laboratories are bound to benefit from the proposal. Notably, the proposal applies only to government laboratories and does not cover private medical device testing laboratories.
Source: shortlink.uk/1sH3N

2. The Central Government has proposed draft amendments to the Medical Devices Rules, 2017 mandating manufacturers outsourcing sterilisation must mention the sterilisation site’s licence number on device labels using specified descriptors. Currently, no such mandatory declaration exists, and the proposal aims to ensure greater accountability in third-party sterilisation processes.
Source: shortlink.uk/1nrZb

3. The Central Government has proposed amendments to the Medical Devices Rules, 2017 requiring importers of Class A non-sterile and non-measuring devices to also self-certify compliance with a Quality Management System. Currently limited to standards, this change aims to strengthen quality assurance and regulatory oversight of low-risk medical device imports.
Source: shortlink.uk/1sH41

4. The Department of Agriculture & Farmers’ Welfare has directed pesticide manufacturers, importers, and industry associations to submit data on produced, imported, and exported quantities of major insecticides, fungicides, herbicides, and Plant Growth Regulators (PGRs) by April 13, 2026. This is being undertaken to assess the impact of the ongoing Gulf Crisis on pesticide availability and supply chains.
Source: shortlink.uk/1sH4g

5. The Central Government has proposed to amend the Medical Devices Rules, 2017, to expand the scope of jurisdictions by including “European Union countries” alongside the US, UK, Australia, Canada and Japan. Pursuant to this amendment, investigational clinical data may not be required to be submitted for import of a medical device, provided that such device has been approved by the regulatory authority of EU, has been marketed in that jurisdiction for a minimum period of two years.
Source: shortlink.uk/1nrZD

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 National Pharmaceutical Pricing Authority (NPPA) has notified a 0.64956% increase in the Wholesale Price Index (WPI) for 2025 over 2024. Importers and manufacturers of Scheduled drugs and medical device are now permitted to increase the prices on the basis of WPI without prior approval from the government from April 1, 2026.
Source: shortlink.uk/1mYsg

2. The Central Drugs Standard Control Organization (CDSCO) has clarified that all IVF-related devices, including sperm washing kits and intrauterine insemination tools, are regulated as medical devices under the Drugs and Cosmetics Act. Import, manufacture, and sale of these devices require proper licensing to ensure compliance and prevent unauthorized trade.
Source: shortlink.uk/1mYsj

3. India’s Central Drug authority, (CDSCO) has streamlined the procedure for review and processing Written Confirmation certificate (WCC) applications submitted through the SUGAM portal for export of Active Pharmaceutical Ingredients (API) to EU for human use. The move aims to improve efficiency aligning with EU GMP compliance requirements under Article 46(2)(b) of Directive 2001/83/EC.
Source: shortlink.uk/1sbyd

4. The National Medical Commission (NMC), following a Supreme Court of India ruling, now limits stem cell therapy to approved conditions only, so far there are 32 approved conditions. Unproven uses outside clinical trials are banned, with strict ethical rules and legal action to prevent misuse and protect patients.
Source: shortlink.uk/1mYsV

5. The Central Consumer Protection Authority (CCPA) has directed hotels and restaurants to stop adding charges such as “LPG charges” and “fuel cost recovery” to customer bills, terming the practice an unfair trade practice, and warning of strict action. The CCPA clarified LPG and electricity, are part of running a business and should be factored into final menu prices.
Source: shortlink.uk/1mYt2

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 clarified no proposal exists for a uniform nationwide pricing framework for medical devices. National Pharmaceutical Pricing Authority continues to regulate ceiling prices for essential devices like stents and knee implants under Drugs Prices Control Order, 2013, while monitoring non scheduled products and taking action against overcharging to safeguard consumer interests.
Source: shortlink.uk/1s0VO

2. The Ministry of Health and Family Welfare approved major reforms to strengthen food safety while improving ease of doing business. Measures include perpetual licences, higher turnover thresholds, deemed registration for street vendors, and risk based inspections, reducing compliance burden and enhancing regulatory efficiency
Source: shortlink.uk/1s0VY

3. The National Biodiversity Authority (NBA) of India has formed an expert committee to address invasive alien species threatening India’s biodiversity, ecosystems, agriculture, and health. It will create a national list, identify high-risk species, and recommend management strategies, research, and guidelines for prevention, control, and ecological restoration over a two-year period.
Source: shortlink.uk/1mOaJ

4. The Delhi High Court has issued notices to the government and CDSCO over alleged inaction on misuse of diabetes drug Ozempic for weight loss, citing non-compliance with earlier directives. The case raises concerns on regulatory oversight, off-label use controls, and potential compliance risks for pharma players amid rising scrutiny.
Source: shortlink.uk/1s0Wd

5. A Parliamentary panel has asked the Ministry of Defence to expedite pending payments to hospitals under the Ex-Servicemen Contributory Health Scheme, warning that delays are forcing private providers to opt out. The move aims to restore service continuity and protect healthcare access for over one crore beneficiaries.
Source: shortlink.uk/1mOaW

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 Pollution Control Board (CPCB) has extended the deadline for registered Producers, Importers and Brand Owners (PIBOs) to file Annual Returns for FY 2024–25 under the Plastic Waste Management Rules, 2016 until March 31, 2026. Non-compliance may attract environmental compensation.
Source: shortlink.uk/1rAfG

2. The Central Pollution Control Board has issued show cause notices to PIBOs for failing to meet EPR obligations and not submitting Annual Returns for FY 2022–23 under the Plastic Waste Management Rules, 2016. Defaulters will face environmental compensation and tighter enforcement from authorities
Source: shortlink.uk/1rAg8
Source: shortlink.uk/1rAga

3. The Central Pollution Control Board (CPCB) has issued show cause notices to producers, importers, and brand owners (PIBOs) for failing to meet Extended Producer Responsibility obligations, fulfil targets, and file annual returns under the Plastic Waste Management Rules, 2016 for FY 2022–23. Non-compliant entities may have to pay environmental compensation, face penalties, and higher future targets. Entities must respond latest by 26.03.2026or face further regulatory and legal action.
Source: shortlink.uk/1mol6

4. The Karnataka government has released a draft policy promoting responsible digital use among students, focusing on curbing screen addiction, cyber risks, and mental health impacts. The move aligns with its broader push to restrict social media access for minors and regulate device usage.
Source: shortlink.uk/1mol8

5. Parliamentary panel has reportedly urged the Department of Pharmaceuticals to address administrative delays affecting the Promotion of Research and Innovation in Pharma MedTech Sector scheme after significant underutilisation of funds. Despite increased allocations, spending remained low. Revised guidelines and stronger monitoring are expected to improve execution and outcomes.
Source: shortlink.uk/1rAgj

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 clarified no proposal exists for a uniform nationwide pricing framework for medical devices. National Pharmaceutical Pricing Authority continues to regulate ceiling prices for essential devices like stents and knee implants under Drugs Prices Control Order, 2013, while monitoring non scheduled products and taking action against overcharging to safeguard consumer interests.
Source: shortlink.uk/1mogz

2. The Ministry of Health and Family Welfare approved major reforms to strengthen food safety while improving ease of doing business. Measures include perpetual licences, higher turnover thresholds, deemed registration for street vendors, and risk based inspections, reducing compliance burden and enhancing regulatory efficiency
Source: shortlink.uk/1rAbJ

3. The National Biodiversity Authority (NBA) of India has formed an expert committee to address invasive alien species threatening India’s biodiversity, ecosystems, agriculture, and health. It will create a national list, identify high-risk species, and recommend management strategies, research, and guidelines for prevention, control, and ecological restoration over a two-year period.
Source: shortlink.uk/1mogO

4. The Delhi High Court has issued notices to the government and CDSCO over alleged inaction on misuse of diabetes drug Ozempic for weight loss, citing non-compliance with earlier directives. The case raises concerns on regulatory oversight, off-label use controls, and potential compliance risks for pharma players amid rising scrutiny.
Source: shortlink.uk/1mogP

5. A Parliamentary panel has asked the Ministry of Defence to expedite pending payments to hospitals under the Ex-Servicemen Contributory Health Scheme, warning that delays are forcing private providers to opt out. The move aims to restore service continuity and protect healthcare access for over one crore beneficiaries.
Source: shortlink.uk/1mogU