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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 Government of India has launched Market Access Support under the Export Promotion Mission to strengthen global market access for Indian exporters. The initiative offers structured support for trade fairs, buyer seller meets, delegations and digital tools, prioritising small exporters, new markets, predictable planning and outcome driven export growth nationwide.
Source: h7.cl/1m6xR

2. The Food Safety and Standards Authority of India (FSSAI) issued an office order mandating a standardized format for food businesses operators, industry bodies, and other stakeholders to submit representations seeking food safety risk assessment. The move aims to ensure complete data submission, improve evaluation, enhance transparency, and speed up regulatory decision-making.
Source: h7.cl/1hakR

3. The Delhi High Court has granted an interim injunction restraining a manufacturer from selling biscuits bearing an identical name, shape and packaging to a registered trademark holder’s product. The court cited prima facie trademark infringement and passing off on triple identity and directed removal of infringing products from the market and e-commerce platforms.
Source: h7.cl/1m6y3

4. The Gujarat High Court has upheld a ruling by the Customs Authority for Advance Rulings allowing duty free import of inshell walnuts by treating the product as “dietary fibre.” The decision confirms that inshell walnuts qualify for exemption from Basic Customs Duty under the Transferable Duty-Free Import Authorization (DFIA) scheme.
Source: h7.cl/1m6y8

5. India’s major pharmaceutical company has signed an exclusive agreement with the other giant to introduce needle-free injection systems for IVF and gynaecology therapies across India. The high-pressure jet delivery tech aims to reduce pain, anxiety and improve patient compliance, with a targeted all-India rollout in FY 2026, addressing millions of injections in the growing fertility market.
Source: h7.cl/1hakq

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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 Ministry of Health and Family Welfare has published a draft amendment to the Medical Devices Rules, 2017, proposing changes to labelling requirements for non-sterile and non-measuring medical devices, along with other regulatory updates. Stakeholders’ comments are invited within 30 days of publication of the draft Rules.
Source: h7.cl/1ghFK

2. India’s Bureau of Indian Standards has notified IS 19493:2025 on hospital bill formats, effective 8 December 2025. The standard specifies mandatory and optional billing elements for hospitals, nursing homes, diagnostic centres, and outpatient clinics, aiming to ensure uniformity, transparency, prevent overcharging, and improve clarity for patients and insurers nationwide.
Source: h7.cl/1ghFQ

3. The Supreme Court of India has issued notices to the Centre and all states on a PIL seeking to declare cancer a notifiable disease nationwide. The move aims to ensure uniform reporting, strengthen surveillance, and improve early detection and patient care through a centralized digital registry amid fragmented state-level data.
Source: h7.cl/1ghG2

4. A pharmaceutical innovator has appealed a Delhi High Court order permitting an Indian manufacturer to produce and export semaglutide to markets where patent protection has lapsed. The court declined interim relief, allowing exports to continue.
Source: h7.cl/1lb5k

5. The Ministry of Information and Broadcasting stated that the Information Technology Rules 2021 safeguard free speech while curbing fake and misleading digital content. Publishers of news must follow a Code of Ethics, intermediaries must prevent false information, and a grievance mechanism and fact checking by Press Information Bureau ensure accountability nationally.
Source: h7.cl/1ghGa

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 food authority (FSSAI) has extended the enforcement date for the amended labelling requirements under the Alcoholic Beverages Regulations, 2025. The earlier deadline of 1 January 2026 is now postponed to 1 July 2026. The decision follows stakeholder concerns that mid-year labelling changes would disrupt operations, cause wastage of pre-printed labels, and create additional costs, especially due to State Excise label-registration cycles.
Source: h7.cl/1kc0S

2. India is reportedly negotiating mutual recognition agreements (MRAs) with major partners such as the US, EU, UK, Singapore and ASEAN to align inspection and testing systems. The aim is to cut rejections, ease trade friction and streamline exports of basmati rice, spices, tea, coffee, marine products, fruits and vegetables, improving global competitiveness.
Source: h7.cl/1flqZ

3. India’s central food authority (FSSAI) has issued amendments to the FSS (Alcoholic Beverages) Regulations, 2018 wherein the permissible maximum level of ethyl acetate esters in alcoholic beverages has been increase from “0.2” g/l to “3.0” g/l.
Source: h7.cl/1kc16

4. India’s Drugs Consultative Committee has agreed to add levonorgestrel tablets in 0.75 mg and 1.5 mg widely known as morning-after pills to Schedule K, enabling continued OTC sales. This also includes provisions for a boxed warning on packaging highlighting side effects, no protection against HIV/STIs, limits on use, and recommendations for consulting practitioners on alternatives.
Source: h7.cl/1kbV8

5. The Supreme Court of India has reportedly directed Noida District Hospital to constitute a primary medical board within two weeks to assess passive euthanasia for a 31-year-old man who has been quadriplegic and in a vegetative state for more than a decade.
Source: h7.cl/1flra

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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 Electronics and Information Technology has notified phased enforcement of the Digital Personal Data Protection Act 2023. Implementation will follow a phased timeline of 12-18 months, introducing consent-based processing, mandatory breach reporting, children’s safeguards, expanded data rights, and a digital-only Data Protection Board, marking the structured rollout of India’s data protection framework.
Source: minilink.pro/1jA7S

2. India’s Ministry of Electronics and Information Technology (MeitY) has recently notified the Digital Personal Data Protection Rules, 2025. The rules mandate clear consent, breach reporting, children’s data safeguards, and a digital-only Data Protection Board. Compliance is phased over 18 months, along with penalties for violations.
Source: minilink.pro/1eLQj

3. The National Pharmaceutical Pricing Authority has extended the existing ceiling prices for orthopaedic knee implants by one more year until November 15, 2026. Manufacturers and importers of orthopaedic knee implants will have to maintain the existing prices till November 15, 2025.
Source: minilink.pro/1jA8h

4. The Food Safety and Standards Authority of India has integrated its Food Import Clearance System with the Central Board of Indirect Taxes and Customs under the SWIFT 2.0 platform. This integration enables faster, more transparent, and technology-driven food import clearance, reducing delays, improving efficiency, and supporting India’s broader trade facilitation objectives.
Source: minilink.pro/1jA97

5. The Union Cabinet has approved the Credit Guarantee Scheme for Exporters (CGSE), offering up to INR 20,000 crore in collateral-free credit with 100 % guarantee via National Credit Guarantee Trustee Company (NCGTC). Including both MSME and non-MSME exporters, the scheme aims to boost liquidity, aid market diversification, and enhance global competitiveness of Indian exports.
Source: minilink.pro/1eLQH

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 Pharmacopoeia Commission (IPC), traditionally responsible for preparing standards for medicines, is now reportedly expanding its role to prepare standards for medical devices in collaboration with the Bureau of Indian Standards (BIS). It has also begun auditing medical device companies and is developing monographs which will outline standards and specifications for medical equipment. This initiative aims to enhance India’s credibility in medical device manufacturing and support export growth.
Source: short-url.org/1c9pE

2. The Telangana High Court set aside a blanket injunction order in a trade secret dispute, holding that confidential information and trade secrets must be clearly identified and proven. It ruled that the trial court erred by granting a blanket restraint and directed a fresh hearing in accordance with law.
Source: short-url.org/1gQnE

3. The Indian government has amended the export policy for rice (both Basmati and non-Basmati) to non-EU European countries, removing the requirement for Export Inspection Council (EIC) certification until April 2, 2026. The EIC certification will, however, remain mandatory for exports to the EU, the UK, Iceland, Liechtenstein, Norway, and Switzerland.
Source: short-url.org/1gQlT

4. The Pharmaceuticals Export Promotion Council (Pharmexcil) has asked pharma exporters to submit cases of delayed or non-payment by overseas buyers to help frame a Standard Operating Procedure (SOP). This SOP aims to streamline the process of addressing payment-related grievances and Pharmexcil’s timely intervention.
Source: short-url.org/1c9p-

5. Tamil Nadu Food and Drugs Administration (FDA) is investigating the license of a local cough syrup manufacturer following child deaths in Madhya Pradesh linked to contaminated cough syrup produced by the company. The scrutiny in Tamil Nadu began after a formal request from the Madhya Pradesh Drugs Control Authority and the state drug regulator. In response to these incidents, India’s Union Health Ministry has issued an advisory urging the rational use of pediatric cough syrups banning them for children under two years, advising caution for older children, and promoting rest and hydration as preferred treatments.
Source: short-url.org/1gQng
Source: short-url.org/1c9qC

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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 NPPA has extended the existing ceiling prices for orthopaedic knee implants until November 15, 2025. The earlier deadline was September 15. The extension allows time to review industry representations while maintaining current ceiling prices.
Source: short-url.org/1eQeU

2. India’s central drugs regulator, has introduced a new online provision, effective 11th September 2025 for “Subsequent Importer” applications. It allows companies to import medical devices and in-vitro diagnostics already approved by CDSCO for marketing in India. The initiative aims to simplify approvals, brand approvals, enhance transparency, and reduce processing timelines.
Source: short-url.org/1eQnm

3. India’s central drug authority has classified pharmaceutical cocrystals of approved active substances as new drugs under New Drugs and Clinical Trials Rules, 2019. Applicants must demonstrate superior properties over physical mixtures, with detailed validation, stability, and bioavailability/bioequivalence data. Submissions will be processed like new active substances, requiring full safety and efficacy evidence.
Source: short-url.org/1afgK

4. Pharmaceutical merchant association are reportedly urging India’s government to revise the rule prohibiting the export of pharmaceutical products labelled “For sale in India only.” They claim the regulation has led to substantial losses, hurting global competitiveness, restricting access for overseas patients, and causing market-share losses.
Source: short-url.org/1eQme

5. Reportedly, one of the leading toothpaste maker company in the United States will update its packaging from November 1 under a settlement order, showing “pea-sized” amounts for children under six to promote safe, age-appropriate fluoride use and address concerns that previous images encouraged potentially unsafe overuse by young children.
Source: short-url.org/1afh5

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 Directorate General of Health Services (DGHS) will now manage doctor registrations in Delhi, following the dissolution of the Delhi Medical Council due to administrative irregularities. This move aims to centralize oversight and restore transparency in medical practitioner regulation.
Source: bit.ly/45sY77v

2. India’s Enforcement Directorate has launched investigations into four pharmaceutical companies based out of state of Uttar Pradesh on suspicion of diverting tramadol. These firms are alleged to have supplied the controlled painkiller for unauthorized distribution, intensifying efforts to curb drug misuse.
Source: bit.ly/443Z5EJ

3. Australia’s health regulator has issued over A$600,000 in fines across multiple medicinal cannabis companies for unlawful advertising, including unapproved health claims. The crackdown highlights strict compliance requirements for prescription-only medicines.
Source: bit.ly/3GazC4x

4. To prioritize domestic supply and reduce China dependence, India has instructed state miner IREL to halt rare earth magnet exports. The move supports local EV and tech industries amidst global magnet shortages.
Source: bit.ly/40erxT8

5. Maharashtra state government reinstates a ₹600 cap on ELISA test for dengue and chikangunya specifically in Pune city amid rising cases and has issued fresh directives to all hospitals and laboratories.
Source: bit.ly/3TxKCvW

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 Department of Pharmaceuticals (DoP) has reportedly issued a communication to all pharmaceutical associations directing them to comply with the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024. As per the directive, companies must submit a self-declaration and marketing expenditure disclosure for the financial year 2024–25 by 31st July 2025
Source: bit.ly/4jvX8Xq

2. The Ministry of Commerce and Industry authorised Ayushexcil, the Ayush Export Promotion Council under Appendix 2E of Foreign Trade Policy 2023 to issue non-preferential Certificates of Origin for Ayush products, streamlining exports and boosting global trade.
Source: bit.ly/4dM0fsZ

3. India’s pharmaceutical sector is expected to remain stable despite the U.S. Executive Order introducing a “Most Favoured Nation” pricing model, which seeks to cut branded drug prices by 30–80% by aligning them with the lowest OECD country prices. CRISIL Ratings reports that strong domestic demand and a focus on generics will help India’s pharma industry withstand these pricing pressures.
Source: bit.ly/45Lwd6y

4. India launches International Biomed Cross (IBC) to create a global network of biomedical engineers for rapid repair, maintenance, and remote support of critical medical equipment during health emergencies and disasters, ensuring uninterrupted healthcare services in underserved and crisis-affected regions.
Source: bit.ly/45Lwd6y

5. The U.S. President Trump has reportedly revoked a Biden-era policy under the Emergency Medical Treatment and Labor Act (EMTALA), 1986 that required hospitals to provide emergency abortions, even in states with abortion bans. This move creates legal uncertainty for hospitals and may limit emergency abortion care for pregnant women.
Source: bit.ly/4mMt1xF

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 released new guidelines permitting the use of recycled polyethylene terephthalate in food packaging. Only recycling technologies that effectively remove contaminants are approved. Manufacturers must conduct safety tests, follow labelling norms, maintain traceability, and undergo audits to ensure food-grade quality and compliance.
Source: bit.ly/43NdGFB

2. The Government of India has reportedly removed port restrictions and Central Leather Research Institute testing for leather exports, helping MSMEs cut costs and delays. Exporters can now ship from any port, boosting efficiency and competitiveness, especially in key markets like the US.
Source: bit.ly/43LV20N

3. Neurologists have reportedly urged for the inclusion of multiple sclerosis (MS) in the National Health Mission, Rare Disease Policy, and Ayushman Bharat. They seek better access to treatment, insurance coverage, updated disability laws, and mental health support for patients.
Source: bit.ly/3Z273N2

4. The Consumer Affairs Ministry to meet key E-commerce companies to combat dark patterns that mislead consumers on May 28, 2025 in Delhi. Major platforms, law universities, and consumer groups to participate, the meeting will also focus on compliance measures and feature discussions on consumer rights protection and industry best practices.
Source: bit.ly/4kI24cR

5. India is urging the U.S. to ease import rules and speed up Phytosanitary approvals for its fruits and vegetables, aiming for broader market access. This move seeks to boost Indian agricultural exports and balance bilateral trade relations.
Source: bit.ly/43CSNM9

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 declined to grant an interim injunction against four influencers who criticized a popular protein brand’s product in YouTube videos. The Court ruled that their comments, based on lab reports, constituted fair comment in public interest and not defamation.
Source: bit.ly/3GxgRIw

2. The Supreme Court of India has ruled that the limitation period for filing appeals under the Commercial Courts Act, 2015, begins from the date the judgment is pronounced, not when the party receives the judgment copy. The Court held that delay in seeking a certified copy doesn’t justify condoning limitation period.
Source: bit.ly/432T5fc

3. An Indian District Consumer Disputes Redressal Commission has ruled against an insurance company for unfair trade practices after it denied a valid accident claim. The complainant signed the discharge voucher but added the words “with protest” to express his disagreement, which led to its denial.
Source: bit.ly/4jtaZi1

4. India’s Department of Pharmaceuticals (DoP) has reportedly requested export data from Pharmexcil, under the Ministry of Commerce and Industry, amid ongoing trade restrictions with Pakistan. The move is aimed at assessing the flow of pharmaceutical products between the two countries.
Source: bit.ly/42Osz96

5. Swissmedic has invited feedback on the International Council for Harmonisation (ICH) Guideline M13B, which aims to harmonize bioequivalence study designs and data analysis methods for immediate-release solid oral dosage forms like tablets, capsules, and granules/powders for oral suspension. Stakeholders may submit feedback until July 9, 2025.
Source: bit.ly/44bvFq2