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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 Jammu and Kashmir and Ladakh High Court ruled that prosecution under the Drugs and Cosmetics Act cannot proceed if the accused is deprived of the statutory right to seek re-analysis of a drug sample by the Central Drugs Laboratory. The court quashed proceedings where the expiry of the sample’s shelf life prevented the accused from exercising this legal safeguard of having the samples tested by the Central Drugs Laboratory.
Source: shortlink.uk/1mQEt

2. India’s central food regulator (FSSAI) has amended the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011. Key changes allow the authority to set turnover thresholds for registration, grant instant registration on document submission, recognize street vendors registered under the Street Vendors law, introduce risk-based inspections and audits, and suspend licences for non-payment of fees or failure to file returns.
Source: shortlink.uk/1mQEx

3. The Central Drugs Standard Control Organisation (CDSCO) has delegated key regulatory functions related to veterinary drugs to its zonal offices. Zonal offices will now process Test License (Form 11) applications for import and issue NOCs for Form 29 licenses for manufacturing veterinary drugs for testing or analysis, excluding biologicals.
Source: shortlink.uk/1s3ug

4. India’s Drugs Technical Advisory Board, in its 93rd meeting, recommended amending the Drugs Rules, 1945 to introduce licensing provisions for drug marketers. The move aims to strengthen regulatory oversight and monitoring of entities that market drugs manufactured by other companies under their own label.
Source: shortlink.uk/1s3uq

5. The Food Safety and Standards Authority of India has reportedly encouraged plant-based food manufacturers to include QR codes on product labels to help consumers easily access ingredient lists and nutritional information. The regulator said the move currently voluntary can address label space limitations, improve transparency, and build consumer trust in the rapidly growing plant-based food sector.
Source: shortlink.uk/1s3uD

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 introduced a prior intimation system for the submission of applications for analytical or non-clinical testing in Forms CT-10, CT-12, and CT-13 under the New Drugs and Clinical Trials Rules, 2019 through the National Single Window System (NSWS) portal. The system does not apply to sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, or narcotic and psychotropic substances.
Source: short-url.org/1qC6E

2. The Government of India is reportedly considering stricter regulation of nicotine lozenges to curb access by minors and non-smokers. The Drugs Technical Advisory Board (DTAB) has reportedly recommended removing 2 mg nicotine lozenges from the exemption, which currently allows certain nicotine replacement therapy (NRT) products to be sold without a drug sale licence. If implemented, nicotine lozenges would largely be restricted to sale through licensed pharmacies.
Source: short-url.org/1lt4O

3. India’s central food regulatory authority (FSSAI) has recently in a Central Advisory Committee meeting urged states and UTs to strengthen enforcement against high-risk food commodities such as milk, edible oils, spices and honey. It called for risk-based inspections, faster recruitment of food safety officers, improved grievance redressal systems, and data-driven surveillance to strengthen monitoring and improve nationwide food safety oversight.
Source: short-url.org/1lt4V

4. Karnataka government has reportedly proposed banning the use of social media by children under the age of sixteen. Chief Minister Siddaramaiah announced the move during the state budget speech, stating that the measure aims to reduce the harmful effects of excessive mobile phone usage on minors across the state.
Source: short-url.org/1lt4-

5. India has outlined a five-pillar strategy to integrate artificial intelligence across healthcare, focusing on governance, data platforms, innovation, workforce capacity, and real-world validation. The framework aims to scale AI-driven diagnostics, public-health surveillance, and digital health infrastructure for pharma, med-tech, and health-tech companies to collaborate in data-driven healthcare innovation.
Source: short-url.org/1lt50

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 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

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 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 Supreme Court has directed the Food Safety and Standards Authority of India (FSSAI) to consider mandatory front-of-pack warning labels on packaged foods. This move aims to inform consumers about high levels of sugar, salt, and saturated fats, addressing rising health concerns like obesity and diabetes. The court emphasized prioritizing public health over industry resistance.
Source: h7.cl/1jEhc

2. The Indian government has tightened the IT intermediary law, by an amendment that defines synthetic media, and require social media platforms to remove flagged harmful content within three hours, enhancing accountability and curbing misuse of AI online. The amendment also obliges intermediaries offering AI tools to deploy technical (including automated) measures blocking unlawful deepfake and synthetic content.
Source: h7.cl/1jEgT

3. India’s Supreme Court has issued notices to the Central Government and National Medical Commission on a PIL seeking exemption of medical professionals from the Consumer Protection Act. The petition argues consumer law undermines doctor-patient trust and promotes defensive medicine. The Court’s decision remains pending.
Source: h7.cl/1jEhX

4. The Supreme Court reportedly directed the Gujarat Pollution Control Board to decide within a week on Pharma company’s plea to reopen its Dahej plant, producing hexafluoro-methoxypropane, a key sevoflurane intermediate. It was shut over alleged hazardous waste discharge into the Narmada River. The court denied interim relief, advising remedies via statutory authorities and the National Green Tribunal.
Source: h7.cl/1jEh-

5. United States Food and Drug Administration reportedly issued a warning that a major pharma company’s Television advertisement for its obesity pill is false or misleading as it suggested unproven superiority and benefits over other GLP one medicines. The regulator directed corrective action to ensure accuracy and protect patients.
Source: h7.cl/1oHAn

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 has reportedly agreed to reduce tariffs on a broad range of U.S. exports, including medical devices, manufactured goods and chemicals from about 13.5% to zero. Lower tariffs on medical devices from the US would help hospitals and clinics in India to procure advanced equipment more cheaply, improving healthcare delivery and access.
Source: h7.cl/1ow26

2. US FDA has shut down over 200 illegal online pharmacy websites linked to an India-based criminal network. The sites allegedly sold unapproved and counterfeit medicines to U.S. consumers, raising serious public health concerns and highlighting the need for stronger regulation and cross-border cooperation.
Source: h7.cl/1ow29

3. The Indian government is reportedly examining a proposal to mandate pharmaceutical companies to allocate at least 1% of their net profits for free medicines during health emergencies by amending the Drugs Rules, 1945. However, the move faces legal constraints, as CSR spending is governed by the Companies Act, 2013. The central drugs regulator, CDSCO, is reassessing the proposal’s feasibility.
Source: h7.cl/1ow2c

4. The Association of Indian Medical Device Industry (AiMEd) has reportedly opposed any reconsideration or easing of policy restrictions on importing refurbished or pre-owned medical equipment. Association has urged the government to uphold the ban on imports, enforce stricter regulations by emphasizing the strengthening of indigenous innovation like Make in India.
Source: h7.cl/1ow2i

5. A leading fast moving consumer goods manufacturer has filed a suit in the Calcutta High Court, alleging deceptive imitation of its biscuit packaging and trade dress by a rival. The suit seeks injunction against sale and distribution, claiming consumer confusion and unfair competition. The court has taken the matter on record and scheduled further hearing shortly.
Source: h7.cl/1jt71

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 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

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 Ministry of Health and Family Welfare has constituted a committee to develop a policy governing refurbished medical devices. The committee will examine the scope of refurbished medical devices, methodology to evaluate the safety, performance, and remaining useful life of refurbished medical devices & suggest guidance for waste disposal of such refurbished devices.
Source: h7.cl/1o8qd

2. Indian government has announced a tax holiday until 2047 for foreign companies that provide cloud services globally using data centres located in India. Further, there will be no risk of foreign firms’ global income being taxed in India solely because they use Indian data centres. This move is aimed at attracting long-term investment into India’s digital infrastructure.
Source: h7.cl/1o8qp

3. Indian Government has released first national evidence-based lung cancer treatment and palliation guidelines. It offers 15 recommendations to standardise diagnosis, treatment and palliative care, improve early detection, reduce treatment disparities and ensure consistent, patient-centred care across the country.
Source: h7.cl/1o8qA

4. India’s Ministry of Consumer Affairs issued show-cause notices to major edible oil companies for violating the amended Vegetable Oils Products, Production and Availability (VOPPA) Order, 2025. Companies failed to submit monthly production data and register on official portals. Authorities have warned that continued non-compliance could lead to inspections and confiscation under the Essential Commodities Act, 1955.
Source: h7.cl/1o8qN

5. The United States Food and Drug Administration has launched the PreCheck pilot program to strengthen domestic pharmaceutical manufacturing. The initiative offers early regulatory engagement for new manufacturing facilities, improving predictability, streamlining facility assessments and accelerating readiness to supply medicines for the United States market.
Source: h7.cl/1o8qS

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 draft amendments to the Food Business Licensing Regulations mandating food manufacturers to keep daily production and raw-material records and to follow FIFO/FEFO storage norms. Retailers and non-manufacturers are exempt. The move strengthens traceability, inventory control, and food safety compliance. Public comments are invited within 30 days of Gazette publication.
Source: h7.cl/1iFOX

2. Madras High Court has ruled that the word “Vapo” is a descriptive and generic term derived from “vapour” and cannot be claimed exclusively by any party, rejecting petitions seeking cancellation of trademarks for “Vaporin” products. The Court held that the rival marks and trade dress are distinct and unlikely to cause consumer confusion.
Source: h7.cl/1nG6S

3. India’s Central Government has amended Uniform Consent Guidelines under the Air and Water Acts to simplify industrial approvals and cut delays. Key changes include consolidated consents covering multiple environmental laws, faster timelines for red-category industries, and Consent to Operate remaining valid until cancelled. Inspections, audits, and cancellation powers remain to ensure environmental compliance.
Source: h7.cl/1iFAP

4. The India–EU free trade agreement is set to eliminate duties on about 90% of European medical devices imported into India, reducing tariffs that earlier went up to 27%. The agreement is expected to lower costs and improve access to advanced technologies, Indian manufacturers are seeking regulatory alignment and mutual recognition to overcome non-tariff barriers.
Source: h7.cl/1iFAU

5. The India–EU Free Trade Agreement is expected to expand opportunities for Indian traditional medicine in Europe. In EU countries where no specific regulations exist, AYUSH practitioners will be allowed to offer services based on their Indian qualifications. The agreement also provides long-term certainty for setting up AYUSH wellness centres and clinics across EU member states.
Source: h7.cl/1iFAX

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 Central Drug and Medical Device Regulator, The Central Drugs Standard Control Organisation (CDSCO), has issued a public notice that it will reject applications if the queries to the applications are not responded within 90 days from the date of receipt of the query on its official application portal called SUGAM portal. A time-bound reminder and rejection mechanism for timely disposal of the pending applications has been introduced. Applications pending for two years will now be rejected after 30 days notice if no response is submitted.
Source: h7.cl/1i6LX

2. India’s Ministry of Commerce and Industry has extended the deadline for importers and manufacturers to obtain BIS certification for aluminium utensils and food and beverage cans covered under the Quality Control Order, 2026. The revised timelines are issued in a phase wise manner based on industry category, beginning from 1 October 2026.
Source: h7.cl/1i6L0

3. Several drug companies are cautious about a new fast approval program under the United States Food and Drug Administration. They fear quicker reviews may weaken scientific scrutiny, increase legal risk, and invite court challenges, even as others support faster access to important medicines for patients nationwide safely.
Source: h7.cl/1i6Lg

4. The Maharashtra Public Health Department has launched dedicated menopause clinics in Pune to provide specialised care for women’s physical and mental health needs. Weekly OPDs will be held every Wednesday at government hospitals, offering medical management, counselling, and lifestyle guidance. The initiative aims to address menopause-related health issues across urban and rural areas.
Source: h7.cl/1n5Uw

5. India’s Ministry of Agriculture and Farmers Welfare has announced that the Seed Act, 2026, to introduces a nationwide seed traceability through QR codes, mandate seed company registration, and impose penalties up to ₹30 lakh for substandard seeds, and safeguards the traditional seed systems and strengths transparency.
Source: h7.cl/1i6Lp