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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. Indian Supreme Court has in a recent judgement held that corporate social responsibility cannot be limited to philanthropy and must inherently include environmental protection. It emphasized that companies have a constitutional duty to protect ecosystems and prevent environmental degradation, making sustainability and biodiversity conservation integral to CSR obligations.
Source: https://h7.cl/1hniW

2. The Indian medical devices regulator has issued an updated risk classification list for oncology devices, superseding the earlier 2020 notification. The revision introduces new categories such as AI-based diagnostics and advanced ablation and hyperthermia systems, and reclassifies certain devices, thereby impacting regulatory pathways under the Medical Devices Rules, 2017.
Source: https://h7.cl/1mjWw

3. The National Accreditation Board for Testing and Calibration Laboratories (NABL) has released a new guide on preparing quality manuals and management system documentation for labs seeking NABL accreditation under ISO/IEC standards.
Source: https://h7.cl/1hnlv

4. The Department of Pharmaceuticals under Ministry of Chemicals and Fertilizers has invited applications under Marginal Investment Scheme for Reducing Import Dependence and Medical Device Clinical Studies Support Scheme, both of which form part of the broader Scheme for Strengthening of Medical Device Industry.
Source: https://h7.cl/1mjYL

5. The Ministry of Finance released detailed FAQs on the Health Security se National Security (HSNS) Cess Act and Rules, clarifying registration, cess computation, returns, machine declaration, abatement and compliance procedures effective from 1 Feb 2026. This guidance supports industry readiness for new cess obligations under the Act.
Source: https://h7.cl/1mjXk

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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. 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 Department of Pharmaceuticals has issued revising guidelines under the Promotion of Research & Innovation in Pharma-MedTech (PRIP) Scheme that enhances support for MSMEs and startups, introduces milestone-based funding, and raises grant ceilings for early and later stage projects, with higher support for strategic innovation areas. Applications can be submitted through the online portal.
Source: short-url.org/1bYPF

2. The Department of Pharmaceuticals has amended its 2023 Pharma-MedTech R&D scheme, earmarking ₹5,000 crore till 2030. Key updates include funding up to ₹100 crore per project, Centres of Excellence at NIPERs, industry-academia collaboration, and priority focus on new drugs, complex generics, biosimilars, and novel medical devices
Source: short-url.org/1gEoB

3. The Reserve Bank of India has announced that banks can now finance acquisitions, with increase in loan limits against listed shares and IPO financing. These steps are expected to boost liquidity, enable smoother strategic deals, and provide corporates greater flexibility in accessing capital.
Source: short-url.org/1bYPm

4. India’s Consumer Affairs Ministry is reportedly scrutinising e-commerce platforms for cash-on-delivery charges and delayed or denied prepaid refunds, practices that may constitute unfair trade or service deficiency. The probe could mandate COD surcharge waivers, stricter refund timelines, and penalties, as withheld payments let platforms earn interest, leaving customers feeling cheated.
Source: short-url.org/1bYPW

5. Private hospitals in Telangana are allegedly paying unqualified Rural Medical Practitioners and Paramedical Practitioners commission amounting to up to 40% of the hospitalisation charges for patient referrals.
Source: short-url.org/1gEoZ

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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 issued the Medical Textiles (Quality Control) Second Amendment Order, 2025. As per this amendment, any manufacturer or importer certified by the Bureau, or those who have applied for certification, and who have declared their existing stock of products, manufactured or imported prior to the implementation date specified in the principal order dated 23rd October 2024, will be permitted to sell, offer for sale, or display such non-BIS-marked stock until 31st December 2025.
Source: short-link.me/19ypP
Source: short-link.me/19yp3
Source: short-link.me/19ypb

2. India’s Ministry of Environment, Forest and Climate Change has extended the deadline for filing annual returns by Producers, Importers, Brand Owners, and Plastic Waste Processors for Year 2024-25 till 30th September 2025.
Source: short-link.me/15cIv

3. The Indian government has implemented a Central Sector Scheme to promote awareness about Ayurveda, Yoga, Unani, Siddha, and Homoeopathy through fairs, media campaigns, research, and quality certification. Measures also include strengthening drug testing, safety monitoring, international collaborations, and regulatory compliance for traditional medicine systems.
Source: short-link.me/19yqL

4. The Ministry of AYUSH has implemented the Central Sector Scheme “AYURGYAN” to boost research, education, and innovation in traditional medicine. It supports capacity building, clinical research, and interdisciplinary studies, including Ayurveda biology. The scheme promotes evidence-based AYUSH practices through collaborations with academic institutions and national research councils.
Source: short-link.me/19yqQ

5. Food Safety and Standard Authority of India has recently issued an advisory directed all licensed food businesses to display the QR code or download link of the “Food Safety Connect” app at their premises. This enables consumers and regulators to verify license details and lodge complaints easily, promoting transparency, digital access, and improved compliance in the food safety ecosystem.
Source: short-link.me/19yqW

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 Karnataka High Court has ruled that cases involving offences related to the manufacture, sale, and distribution of drugs and cosmetics under Chapter IV can only be tried in a sessions court. The magistrate court must send the case to the Sessions Judge for trial. The court clarified that while no court lower than a Sessions Court can try these offences, it does not mean that the Sessions Court can take cognizance of the case directly without a committal order from the Magistrate’s Court.
Source: bit.ly/41uSVNZ

2. The Kerala High Court ruled that a married woman can undergo IVF with donor sperm even if her husband exceeds the age limit under the Assisted Reproductive Technology (Regulation) Act, 2021 as long as he provides consent. The Court laid down that the age criteria apply individually to men and women, ensuring fair access to ART services.
Source: bit.ly/4gTEffT

3. The Ministry of Textiles has released a comprehensive list of technical textile products included under the Production Linked Incentive (PLI) Scheme. This list encompasses medical and hygiene textiles like baby diapers, sanitary napkins, surgical dressings, and compression stockings. The scheme is designed to enhance India’s production capabilities in healthcare textiles, increase global competitiveness, and create job opportunities.
Source: bit.ly/3F5jW1w

4. The European Commission is seeking feedback from stakeholders on a proposal to extend the option of providing electronic instructions for use (eIFU) for all medical devices, not just high-risk products. The Commission’s proposal suggests that manufacturers of medical devices and their accessories be permitted to provide instructions in electronic form, rather than on paper, for professional users, in line with Regulation (EU) 2017/745. This move aims to reduce paper waste and improve accessibility for healthcare professionals.
Source: bit.ly/41hBFdz

5. Amid the looming threat of a 25% tariff on pharmaceutical imports, Indian drugmakers, are confident they can remain competitive in the US generics market. Major Indian drug manufacturers emphasized that shifting production to the US isn’t feasible, and Indian companies will continue offering cost-effective alternatives despite the tariff.
Source: bit.ly/41hqCRL

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 Madras High Court has refused to impose a ban on advertisements by doctors and hospitals in the media, stating that it cannot expect media outlets to verify every advertisement on fake drugs, hospitals and treatments. The court acknowledged concerns about misleading advertisements and stated that doctors and hospitals should have self-regularisation and in case of violation the Medical Commission should take action.
Source: bit.ly/3CzfDu4
2. The Supreme Court of India raised serious concerns about live surgery broadcasts, citing risks to patient safety and informed consent. The court noted the absence of officials from the National Medical Commission and the Central Government during a hearing, emphasizing the need for guidelines to regulate such practices effectively.
Source: bit.ly/4fyc8CM3.

3. The Union Minister for Chemicals and Fertilizers, Jagat Prakash Nadda, has launched a new initiative called the “Scheme for Strengthening the Medical Device Industry,” to enhance manufacturing, skill development, clinical studies, and infrastructure in the medical device sector. It includes five sub-schemes designed to reduce import dependence and promote domestic production, ultimately supporting India’s goal of self-reliance in healthcare.
Source: bit.ly/4fjICRq

4. The Supreme Court of India has ordered the government to enforce mandatory accessibility rules under the Rights of Persons with Disabilities (RPWD) Act, 2016 emphasizing the need for compliance to ensure public spaces are accessible for disabled individuals. The court has given the government three months to establish clear guidelines and penalties for non-compliance.
Source: bit.ly/3UNULWl

5. Reportedly, government entities in India are exempt from the Digital Personal Data Protection (DPDP) Act, 2023, which permits them to process personal data under specific circumstances without following the Act’s normal provisions. Hospitals, however, are not granted this exemption and must therefore abide with data privacy regulations.
Source: bit.ly/3CkdRwZ

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. Indian pharmaceutical manufacturers will have to prove compliance with revised Good Manufacturing Practices at the time of renewal of manufacturing license, as per media reports.
Source: bit.ly/3MAGjg9

2. A woman who has filed for divorce should be treated as a divorced woman for the purposes of medical termination of pregnancy, and therefore will have the right to terminate her pregnancy: High Court
Source: bit.ly/4fNDhT7

3. The Multidisciplinary Committee of Experts (MDC), which advises the National Pharmaceutical Pricing Authority (NPPA), will invite an officer not below the rank of Deputy Controller of Patents and Designs, to evaluate eligibility for exemption of patented drug from application of price control law.
Source: bit.ly/46Ya8jY

4. A new scheme to boost domestic medical device industry in India is under works and will reportedly be launched in a month.
Source: bit.ly/4fUqrSU

5. A new portal for reporting adverse events of drugs, vaccines and medical devices has been launched by Indian Pharmacopoeia Commission. The adverse event may be reported by consumers and medical practitioners.
Source: bit.ly/4dxeUXY