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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 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

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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 Supreme Court of India has urged the Union Government to enact a comprehensive law governing passive euthanasia and end of life care in India. The Court noted that the absence of legislation has repeatedly required judicial guidelines, while permitting withdrawal of life sustaining treatment for a patient in a prolonged vegetative state.
Source: short-url.org/1qSHk

2. The Drugs Technical Advisory Board (DTAB) has recommended amending entry no. 33 of Schedule K to permit only unflavoured nicotine gums (2 mg) under sale license exemptions. Nicotine lozenges (2 mg) are excluded. Sale to minors is prohibited, online access closely monitored, and marketing by the tobacco industry restricted.
Source: short-url.org/1qSHq

3. A Mumbai Sessions Court has set aside criminal proceedings against directors of an e-commerce platform in a case concerning alleged online sale of abortion pills. The court held that the company operates as an intermediary marketplace and cannot be held directly liable for products listed by third-party sellers, highlighting limits on platform liability in e-commerce
Source: short-url.org/1lJ8-

4. The Drugs Technical Advisory Board (DTAB) has recommended introducing a separate form for wholesale bulk drug licences to capture details of wholesalers dealing with NDPS substances. Qualification criteria for competent persons and adequate transition time for existing wholesaler licensees to obtain the new licence is also proposed by DTAB
Source: short-url.org/1lJ9e

5. The Central Drugs Standard Control Organization (CDSCO) has issued an advisory warning manufacturers, importers and marketing authorisation holders against direct or indirect promotion of prescription medicines, including GLP-1 receptor agonists. The regulator noted that surrogate advertising, misleading efficacy claims and promotional campaigns increasing product visibility may constitute misleading marketing practices.
Source: short-url.org/1lJ9i

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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 licensing authority, CDSCO has issued an alert on the theft of Lantus® SoloStar® insulin (Batch No. 5F0347B) belonging to Sanofi India during transit in Odisha. As the product requires cold-chain storage at 2–8°C, quality risks exist. CDSCO has issued an advisory to healthcare professionals, patients and regulators.
Source: short-url.org/1qgYH

2. India’s central drug regulator reportedly circulated a proposal from the Ministry of Cooperation that would allow Primary Agricultural Credit Societies (PACS) to operate Jan Aushadhi Kendras without registered pharmacists through restricted drug licences, aiming to expand access in underserved areas. The pharmacist community has raised serious concerns, arguing this move could weaken professional standards and patient safety.
Source: short-url.org/1qgYM

3. The Food Safety and Standards Authority of India has issued draft amendments to the Food Products Standards and Food Additives Regulations, 2011 proposing several changes. Stakeholders may submit objections or suggestions within sixty days from publication of the notification. The authority will consider all representations before finalising the proposed regulatory amendments.
Source: short-url.org/1qgYz

4. A court has granted interim relief in a trademark dispute involving the shape of a toilet cleaner bottle. It held that product shape can receive trademark protection even after design registration expires. Observing strong similarity between competing bottles, the court restrained sale of the allegedly infringing product pending further proceedings.
Source: short-url.org/1qgZN

5. The Madras High Court has stayed a single judge’s observation declaring the term “Vapo” as public property in a trademark dispute concerning vapour-based medicinal rubs. The Division Bench held that the finding requires further examination, while allowing continued use of the contested registered mark pending adjudication of the appeals.
Source: short-url.org/1l8DX

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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 Indian Government has recently amended the Legal Metrology (Packaged Commodities) Rules, 2011, mandating all e-commerce entities selling imported products to display country-of-origin details through searchable and sortable filters. The amendment, will take effect from July 1, 2026 to ensure transparency.
Source: short-url.org/1p5FU

2. The Central Consumer Protection Authority has imposed a penalty on an e-commerce platform for listing a toy for sale that failed to meet mandatory quality control order for toys and Bureau of Indian Standards requirements. The Authority held the platform liable for unfair trade practices and directed strict compliance and improved consumer grievance disclosures.
Source: short-url.org/1k0GC

3. The Supreme Court of India has expressed dissatisfaction with FSSAI’s affidavit and urged it to seriously consider introducing mandatory front-of-pack warning labels on packaged foods high in sugar, salt, and saturated fats, citing global norms and public-health concerns. The bench has asked FSSAI to report back within weeks, signalling heightened regulatory scrutiny on nutritional transparency.
Source: short-url.org/1k0CS

4. The Indian government is reportedly set to introduce stringent blood centre regulations to curb ‘professional donor’ rackets and unsafe practices by restricting licences to registered voluntary/charitable organisations, barring family-run entities, and mandating ethical, operational and social accountability standards. The overhaul prioritises voluntary donations, audited infrastructure, and rigorous screening to reduce transfusion infection risks and enhance public health outcomes.
Source: short-url.org/1k0GD

5. The Indian government has granted a transitional exemption under the Electrical Appliances (Skin or Hair Care) Quality Control Order, 2023. The exemption applies to goods ordered before 6 March 2025 and the Bill of the Landing and the Bill of Entry are dated on or before 180 days from the QCO came into force. The importers will be exempted from the requirement provided they submit specified import documents to BIS within seven days of clearance.
Source: short-url.org/1p5FD

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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 Ministry of Health has issued draft amendments to the New Drugs & Clinical Trials Rules, 2019 introducing a framework for filing of post-approval changes in new drugs. Manufacturers of new drugs may have to take prior approval from the authorities for major and moderate quality changes while minor quality changes might be implemented without prior approval and changes which might have a minimal effect can be implemented with annual submission by 1st quarter of every calendar year to the authorities.
Source: h7.cl/1odSN

2. The Delhi High Court upheld the conviction of a sweet manufacturing unit for discharging untreated effluents into public sewers leading to the Yamuna River. However, citing the 2024 amendment to the Water Act, which replaces imprisonment with monetary penalties, the court set aside the jail term and imposed an ten lakh rupees penalty, underscoring strict environmental compliance.
Source: h7.cl/1jbwq

3. The National Biodiversity Authority has launched a digital portal for electronic issuance of Certificates of Origin for cultivated medicinal plants, enabling access and benefit sharing exemptions. The initiative operationalises the amended Biological Diversity framework, offering a single window online process for traditional medicine, seed and research sectors.
Source: h7.cl/1odSP

4. The Government has amended the Plant Quarantine Order to permit the import of dried Mitragyna speciosa (Kratom) leaves from Uganda for processing, subject to a phytosanitary certificate confirming the consignment is free from soil, quarantine weed seeds, and other plant debris.
Source: h7.cl/1jbwX

5. The Karnataka High Court has stayed a penalty imposed by the Central Consumer Protection Authority on an e-commerce platform for allowing the sale of walkie-talkies without mandatory licensing disclosures. The E-commerce platform had argued that its liability is limited owing to it being a mere intermediary.
Source: h7.cl/1jbx0

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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 Pollution Control Board (CPCB) has notified the establishment of a National Control Room (NCR) to coordinate and monitor nationwide enforcement of the ban on identified single-use plastic items. The NCR will support clarity, compliance tracking, stakeholder guidance, state control room reporting, inspections and awareness campaigns.
Source: h7.cl/1lmmL

2. The National Medical Commission has directed medical colleges to establish committees to monitor prescription practices, emphasising clear and legible handwriting and the use of generic drug names. The directive aims to strengthen patient safety, promote rational prescribing, and integrate these practices into medical education nationwide.
Source: h7.cl/1lmm6

3. Food Safety and Standards Authority of India has reportedly directed all states and Union Territories to launch a nationwide enforcement drive against adulteration and misbranding of milk, paneer and khoya. The move follows repeated detections and aims to protect public health through strict inspections and penalties across country.
Source: h7.cl/1gsAC

4. More than 60% of registered small and medium pharmaceutical units in India reportedly risk shutting down by December 2025 due to non-compliance with revised GMP (Schedule M) quality standards. Industry stakeholders warn of potential medicine shortages, job losses, and export disruptions if compliance challenges are not addressed promptly.
Source: h7.cl/1gsAd

5. The EU’s Medical Device Coordination Group has issued new guidance clarifying criteria for qualifying breakthrough medical and IVD devices under MDR/IVDR. It defines key criteria such as significant clinical benefit, unmet medical need, and innovation level, aiming to harmonize interpretation across authorities and support early regulatory engagement without lowering safety or evidence requirements.
Source: h7.cl/1lmli

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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 Competition Commission of India has ordered three Maharashtra liquor trade associations to cease anti-competitive practices, including influencing prices and restricting market access. The CCI found the groups violated the Competition Act and directed them to stop such conduct, though no monetary penalties were imposed.
Source: h7.cl/1g7kN

2. The Punjab government has issued strict new directives for private hospitals to curb exploitation, including mandated humane treatment protocols and safeguards in sensitive situations like patient death. The move aims to strengthen patient rights and accountability in healthcare delivery amid public concerns over unethical practices.
Source: h7.cl/1l0ob

3. Karnataka’s Health Minister has reportedly cautioned private hospitals against conducting unnecessary caesarean deliveries for financial gain, stating that violations under the Karnataka Private Medical Establishments Act may attract penalties up to fifty thousand rupees and potential cancellation of registration, following due process, if establishments fail to comply with regulatory directions.
Source: h7.cl/1l0p7

4. The All India Organisation of Chemists and Druggists has reportedly urged the Prime Minister to halt illegal e-pharmacy operations and withdraw proposed drug regulations, warning that unregulated online medicine sales, especially antibiotics, violate key laws and dangerously accelerate antimicrobial resistance, creating a significant threat to India’s public health system.
Source: h7.cl/1l0o0

5. The Indian Medical Parliamentarians’ Forum has reportedly warned that funding gaps and delays in India’s Rare Disease Policy are disrupting life-saving enzyme therapy for Lysosomal Storage Disorder patients. Over 60 patients have exceeded the ₹50-lakh cap and nearly 100 face imminent treatment loss, prompting urgent calls for expanded funding and sustained government support.
Source: h7.cl/1g7iS

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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 CDSCO via a circular has directed all licensing authorities to ensure that retail and wholesale pharmacy stores prominently display the designated Pharmacovigilance Programme of India (PVPI) QR code and toll-free number. This initiative aims to facilitate easy and seamless reporting of adverse drug reactions (ADR) by the public, strengthening drug safety monitoring.
Source: h7.cl/1jLf0

2. FSSAI has issued an advisory for dairy units selling milk/milk products via vending machines and kiosks, directing them to maintain approved rapid-test kits on-site for detecting common adulterants. The machines must display usage instructions, enable consumer self-tests or staff-demonstrations, retain usage records, and ensure kit validity and proper storage.
Source: h7.cl/1jLfi

3. The Food Safety and Standards Authority of India (FSSAI) has reportedly directed immediate removal of fruit-based beverages, R-T-S drinks and energy drinks labelled with the term “ORS” from retail and e-commerce platforms, reaffirming that only formulations meeting WHO oral-rehydration-solution standards may use “ORS”.
Source: h7.cl/1jLft

4. Indian Government reportedly plans to amend the Drugs and Cosmetics Act by adding sale licensing conditions a per which advertising of high-risk drugs in Schedules G, H, H1 and X will be explicitly banned, including via e-commerce and digital platforms, in order to curb self-medication, misleading claims an misuse of potent medicines.
Source: h7.cl/1jLfQ

5. Indian Government is reportedly framing a broader medical-device manufacturing policy aimed at cutting the country’s heavy import dependence. The plan focuses on boosting domestic production, introducing quality standards for thousands of devices, promoting zero-defect manufacturing, and strengthening India’s global competitiveness in the healthcare technology sector.
Source: h7.cl/1eWCg

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 (FSSAI) has issued the Draft Food Safety and Standards (Alcoholic Beverages) Amendment Regulations, 2025, proposing tighter standards for special wine. The draft introduces a 0.3% sugar tolerance for “Brut” sparkling wine, removes “special wine used,” and makes standard-drink labelling mandatory. A format for public comments has been shared, and feedback is open until 3rd January 2026.
Source 1: urli.info/1jcbJ
Source 2: urli.info/1eoEY

2. The Central Drugs Standard Control Organisation (CDSCO) has reportedly instructed state drug controllers to immediately initiate inspections under the revised Schedule M for the manufacturing units that have not applied for extensions. For manufacturing units that have applied for extensions, the effective date for revised Schedule M implementation is January 1, 2026. The directive follows recent safety lapses, including the fatal cough-syrup incident.
Source: urli.info/1eoDR

3. The Goa Directorate of Food and Drugs Administration (DFDA) has directed all retail pharmacies to display QR codes to facilitate reporting of adverse drug reactions (ADRs) through the Indian Pharmacopoeia Commission’s ADR Monitoring System. QR codes must be prominently displayed to enable consumers and healthcare professionals to report ADRs.
Source: urli.info/1jcb0

4. The Indian Pharmacopoeia Commission, in partnership with NITI Aayog and the Central Tuberculosis Division, will reportedly develop new monographs for the anti-tuberculosis medicines delamanid, pretomanid and the rifapentine-isoniazid fixed-dose combination to enhance quality standards, support rational use and strengthen adverse-drug-reaction reporting.
Source: urli.info/1jcaF

5. The Food Safety and Standards Authority of India (FSSAI) has issued an advisory clarifying stating that honey samples exceeding the permissible 80 mg/kg limit for Hydroxymethylfurfural (HMF) shall be classified as “Substandard”, not “Unsafe.” The clarification follows the Scientific Panel’s view that current research is insufficient to determine health risks from higher HMF levels.
Source: urli.info/1eoD4

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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 Health Ministry has directed all manufacturers of high-risk pharma-grade solvents to obtain or register their licences on the ONDLS portal and upload batch-wise details, including quantity, CoA, and vendor information. A list of high-risk solvents has been issued, and State Drug Regulators have been directed to ensure that no batch is sold without compliance to these directions.
Source: urli.info/1iJjN

2. Central Drugs Standard Control Organization (CDSCO) has clarified that manufacturers of risk Class A and B medical devices not listed in its risk classification list must obtain proper risk classification from CDSCO before applying for a manufacturing licence. Investigational medical device manufacturers must also secure prior CDSCO permission before the grant of manufacturing licence.
Source: urli.info/1dXH7

3. India’s Central Drugs Standard Control Organization (CDSCO) has issued a list of Class A non-sterile and non-measuring (NSNM) medical devices which are exempted from licensing requirements. Manufacturers and importers of the listed devices must obtain CDSCO registration as Class A NSNM medical devices under the Medical Devices Rules, 2017.
Source: urli.info/1dXHz

4. The National Company Law Appellate Tribunal has ruled that the Competition Commission of India lacks jurisdiction to investigate alleged anti-competitive conduct involving patented pharmaceutical products, emphasising that the Patents Act, 1970 prevails over the Competition Act, 2002 when the conduct in question arises from the exercise of patent rights.
Source: urli.info/1dXHI

5. The Delhi High Court has upheld the FSSAI’s directive prohibiting companies from using the term “ORS” (Oral Rehydration Solution) on product labels unless the formulation meets prescribed standards. The Court held that public health considerations override commercial claims and that products misleadingly labelled as “ORS” could endanger consumers. While the company may request FSSAI permission to re-label existing stock, the ban itself remains in force.
Source: urli.info/1iJkL