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) plans to consult subject matter experts to determine a separate pricing structure for cementless knee implants, aiming to ensure affordability and accessibility for patients requiring these advanced medical devices.
Source: bit.ly/43XywRM

2. The Indian Pharmaceutical Alliance (IPA) has expressed opposition to the government’s recent directive limiting the entry of medical representatives into Central government hospitals, arguing that such restrictions could hinder the dissemination of critical medical information to healthcare professionals.
Source: bit.ly/4kDnNCZ

3. The Ministry of Electronics and Information Technology (MeitY) is considering the discontinuation of the bundled consent mechanism, proposing stricter regulations to enhance data privacy and security standards in digital platforms.
Source: bit.ly/4kE8qdH

4. India has asserted its stance on protecting pharmaceutical innovations, countering recent patent infringement allegations from Switzerland, and emphasizing the country’s commitment to safeguarding public health interests.
Source: bit.ly/4n66Lzd

5. The U.S. Department of Agriculture is set to introduce new dietary guidelines for schools, aiming to reduce added sugars and sodium in meals, promote plant-based options, and support local agriculture, thereby enhancing student health and nutrition.
Source: bit.ly/3Hzzv2P

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 is reportedly preparing to ramp up oversight of quick commerce platforms following a series of hygiene and food safety lapses at their dark store facilities. FSSAI plans to conduct unscheduled surprise inspections nationwide to enforce stricter compliance, particularly concerning hygiene and the sale of near-expiry products.
Source: bit.ly/43QmomR

2. The Department of Pharmaceuticals (DoP) has revised its 2024 guidelines for its Capacity Building and Skill Development sub scheme under the Strengthening of Medical Device Industry initiative. New criteria include minimum admission thresholds at least 30% in the first year and 50% in subsequent years failure of which results in withdrawal of funding.
Source: bit.ly/4dW0OR2

3. The Supreme Court of India ruled that the right to shut down a business is part of Article 19(1)(g), subject to reasonable restrictions like protecting workers and following legal procedures. It emphasized that authorities cannot delay valid closure requests or overstep their powers.
Source: bit.ly/4e2FABh

4. The Indian Pharmaceutical Association has reportedly urged reforms in e-prescription rules to prevent misuse through repeated use of digital prescriptions. It recommends a mandatory ‘dispensed’ stamp, encrypted prescriptions or direct doctor-to-pharmacy transmission, but experts warn this could restrict patient rights, access, and create pharmacy monopolies.
Source: bit.ly/4ejdfa1

5. FSSAI has released the Draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2025, proposing new standards for cheese powder, removing “fish” from the animal definition, and banning additives in atta, rice, millet, and mixed millet flours. Public feedback is invited until August 8, 2025.
Source: bit.ly/4e8UW7i

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 Health Ministry has requested the Department of Animal Husbandry and Dairying (DAHD) to share data on veterinary antibiotic manufacturers involved in the manufacturing, distribution, and sale of veterinary antibiotics. Additionally, members will be nominated for Antimicrobial Use (AMU) data collection and coordination with the Joint Working Group.
Source: bit.ly/4l6iHPD

2. India is expanding the availability of the HPV vaccine through Jan Aushadhi Kendras to improve accessibility and affordability. In addition, 116 essential generic medicines have been added to the national list thereby enhancing preventive healthcare efforts and strengthening the pharmaceutical supply chain.
Source: bit.ly/3FyEAIj

3. An Ayurveda professor from Banaras Hindu University (BHU) has written to Prime Minister of India, seeking an exemption under the Minamata Convention, an international treaty banning mercury use, to allow the continued use of mercury in traditional Ayurvedic medicines as it is vital for preserving their potency.
Source: bit.ly/45j9M8J

4. The United States Food and Drug Administration (US FDA) has released draft Questions & Answers (Q&A) guidance detailing the process for transferring ownership of 510(k) premarket notifications. Stakeholders may submit comments until August 4. The guidance aims to help sponsors ensure a smooth and compliant ownership transition process.
Source: bit.ly/4kBADSd

5. The United States Food and Drug Administration (US FDA) issued draft guidance and a proposed order outlining documentation for minor dosage form changes in highly soluble, highly permeable OTC monograph drugs. A separate order requires certain OTC monograph drugs to be packaged in single- or unit-dose containers for regulatory compliance.
Source: bit.ly/4jHnntZ

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 Consumer Protection Authority (CCPA) has directed all e-commerce platforms to conduct self-audits within three months to eliminate ‘dark patterns’. Platforms are encouraged to submit self-declarations affirming compliance with the 2023 Guidelines for Prevention and Regulation of Dark Patterns.
Source: bit.ly/43SkWPg

2. Indian Government is reportedly planning to introduce a Minimum Import Price (MIP) on pharmaceutical raw materials including Key Starting Materials (KSMs), drug intermediates, and Active Pharmaceutical Ingredients (APIs) to curb the influx of low-cost Chinese imports and support domestic manufacturers.
Source: bit.ly/3Tjvdz6

3. The Ministry of Agriculture and Farmers Welfare has notified the draft Insecticides (Amendment) Rules, 2025, aimed at simplifying licences for insecticides used for household purposes. The amendments reduce application timelines from 90 to 30 days, mandate QR codes on retail packs, and applicants applying for renewal must now meet the educational qualification requirement and require applicants renewing their licences to meet the prescribed educational qualifications.
Source: bit.ly/43PCD23

4. India’s National Consumer Disputes Redressal Commission upheld LIC’s appeal, affirming that insurance contracts require utmost good faith (uberrimae fidei) and placing the burden of disclosure on the insured. Citing the insured’s failure to disclose a prior medical condition as material, it found the State Commission’s award flawed and ordered a fresh review.
Source: bit.ly/3SHoBKU

5. India’s Ministry of Finance has revised several General Financial Rules (GFRs) to ease and expedite procurement processes for scientific equipment and consumables in government-funded research and S&T institutions, by raising financial limits for direct purchases and tenders by head of institutes.
Source: bit.ly/3Zlo8lo

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 Environment, Forest and Climate Change has issued the draft Plastic Rules to mandate the use of recycled plastic in plastic packaging from FY 2025-26. Category-wise targets are specified, and CPCB may allow exemptions in cases involving statutory or technical constraints along with a three-year carry-forward for shortfalls in initial compliance. Stakeholders can submit objections to the draft within 60 days.
Source: bit.ly/4e0zhxV

2. Active Pharmaceutical Ingredients (API) prices, which surged during the COVID-19 pandemic, are now declining, easing cost pressures on India’s pharmaceutical industry. As the sector relies heavily on imports from China, the drop in raw material costs is improving profit margins and providing much-needed relief to drug manufacturers.
Source: bit.ly/4dOkypE

3. The Ministry of Agriculture and Farmers Welfare has made amendment to Insecticides Rules, 1971 and introduced the new labelling requirement. Labels must follow new formats by pack size, include QR codes, safety warnings, and detailed info in Hindi and English. The said amendment comes into effect from June 3, 2025, with a phased compliance timeline for industry implementation.
Source: bit.ly/45hnclP

4. Indian Government has launched the ‘Ayush Nivesh Saarthi’ portal to attract global investment in traditional medicine. The platform offers a unified interface for investors, integrating policy frameworks, incentive schemes, and investment-ready projects. This initiative aims to position India as a global hub for traditional medicine and wellness
Source: bit.ly/45bCTe5

5. The European Medicines Agency (EMA) has published a draft guideline for public consultation, offering recommendations on including or retaining pregnant and breastfeeding individuals in clinical trials. The aim is to generate reliable clinical data to support informed, evidence-based treatment decisions for these populations.
Source: bit.ly/43xtYCH

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 government has directed state-run hospitals to procure medicines and consumables exclusively through the Central Procurement Agency (CPA), aiming to streamline procurement and reduce costs, as earlier methods through direct purchases or via the cart feature on the Government e-Marketplace (GeM) portal often resulted in inflated pricing.
Source: bit.ly/4krkAX0

2. Central Pollution Control Board (CPCB) has reportedly initiated action against pan masala brands in Delhi for using plastic sachets to pack and store tobacco and pan masala. Companies may face fines unless they switch to eco-friendly packaging alternatives, per CPCB directives.
Source: bit.ly/4kJM7CW

3. Public health and consumer organisations are reportedly urging the government to add mandatory warning labels on the front of packaged food products that are high in salt, sugar, and fat. They want the Health Star Rating system to be scrapped, saying it misleads people and protects food companies.
Source: bit.ly/3ZjbNOu

4. The Delhi Pollution Control Committee (DPCC) has issued a Standard Operating Procedure (SOP) to streamline the imposition and recovery of environmental compensation from violators of environmental norms. The SOP mandates timely issuance of show cause notices within five days of inspection, a 15-day response window for violators, and follow-up actions within 30 days.
Source: bit.ly/3ZjTVmx

5. India’s Health Ministry is reportedly expanding Schedule H under the Drugs Rules, 1945, raising the number of prescription-only drugs from 536 to over 700. This includes remdesivir, dexamethasone, favipiravir, ivermectin, and mebrofenin etc. The move aims to curb antimicrobial resistance by restricting OTC sales, covering drug classes like cardiovascular, neurological, respiratory, anesthetic, immunological, NSAIDs, and sterile formulations
Source: bit.ly/3ZKZACb

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 Indian government has barred medical representatives from meeting doctors in central government hospitals to curb unethical practices. Instead of in-person visits, pharmaceutical companies are now encouraged to communicate updates to doctors through digital channels such as email.
Source: bit.ly/4ksiiaj

2. Health Ministry of India is reportedly set to implement mandatory Nucleic Acid Testing (NAT) to improve the screening of imported blood products to enhance transfusion safety. NAT detects infections like HIV and Hepatitis B during the early “window period,” reducing transmission risks.
Source: bit.ly/43NZxqI

3. The Karnataka government has amended the Cigarettes and Other Tobacco Products Act (COTPA), raising the legal age for purchasing tobacco products from 18 to 21 years. The amendments also ban hookah bars statewide and increase fines for use of tobacco products in public.
Source: bit.ly/43E0rpC

4. Several corporate maternity hospitals in Hyderabad are reportedly under review for charging extra fees for ‘muhurat’ (auspicious time) deliveries, often conducted through scheduled C-sections, raising ethical and regulatory concerns.
Source: bit.ly/3ZNxjuK

5. Indian Council of Medical Research survey reveals over 40% of sub-district public hospitals in 7 states lack basic diabetes and hypertension medicines. Many also do not have essential diagnostic tools, exposing critical gaps in rural healthcare for managing common non-communicable diseases.
Source: bit.ly/4kjtINm

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. CPCB Mandates Disclosure of Labelling Methods on Plastic Packaging Effective July 2025
India’s Central Pollution Control Board (CPCB) has notified that, effective from 1st July 2025, all producers, importers, and brand owners of plastic packaging who provide the mandatory information on plastic packaging as required under the labelling and marking rules of the Plastic Waste Management Rules, 2016, on plastic packaging, whether through a barcode, QR code, information brochure, or unique number, must mandatorily inform the CPCB using the prescribed format.
Source: bit.ly/3ZfEDzj

2. CPCB Mandates Immediate Registration of Plastic Raw Material Manufacturers and MSMEs on Centralized EPR Portal
India’s Central Pollution Control Board (CPCB) has notified that many manufacturers, importers, sellers of plastic raw materials, and MSME producers have not registered on the Centralized EPR Portal for plastic packaging, despite the mandatory requirement. The CPCB urges all concerned entities to complete their registration immediately to ensure compliance. Failure to do so may result in actions for non compliance under the Plastic Waste Management Rules, 2016.
Source: bit.ly/43ZznCo

3. AYUSH Ministry launches Ayush Suraksha portal to monitor misleading ads and ensure safety in traditional medicine
The Ministry of Ayush has launched the ‘Ayush Suraksha’ portal to monitor and address misleading advertisements and adverse drug reactions in traditional medicine. The platform was launched on May 30, 2025 and it enables real-time reporting and regulatory coordination to safeguard public health.
Source: bit.ly/4kFxQam

4. BIS Notifies New Terminology Standard for Meat Products Other Than Poultry
The Bureau of Indian Standards has introduced IS 8539 (Part 2): 2025, establishing standardized terminology for meat products and meat animals other than poultry. This new standard, effective from 22 May 2025, aims to promote uniformity and clarity in meat industry terminology, enhancing regulatory compliance and product communication.
Source: bit.ly/43oRWQn

5. IMA Warns Government Against Mixopathy, Citing Risks to Patient Safety and Medical Standards Integrity
The Indian Medical Association (IMA) cautions against the Indian government’s push to integrate traditional and modern medicine, termed “mixopathy.” It warns this move may compromise patient safety, dilute medical standards, and result in inadequately trained practitioners, urging authorities to reconsider such unscientific and potentially harmful healthcare initiatives.
Source: bit.ly/43VRxoB

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 an advisory directing food businesses to stop using “100%” claims on labels and promotional materials, citing them as misleading and undefined under current regulations. The move aims to protect consumers from deceptive marketing practices.
Source: bit.ly/3FidCVc

2. India’s Central Drugs Standard Control Organisation (CDSCO) has released guidelines for safe disposal of expired and unused medicines. It mandates flushing 17 high-risk drugs like fentanyl and diazepam to prevent harm. The guidance urges states to establish Drug Take Back programs under biomedical waste rules to curb misuse, environmental risks, and promote responsible pharmaceutical waste management.
Source: bit.ly/4jqNO70

3. The Bureau of Indian Standards has issued Amendment on 22 May, 2025 to IS 17349:2020, the medical textile standard for shoe covers. The revised standard enhances quality and safety. The old standard will remain in force till November 21, 2025.
Source: bit.ly/4dDEuf3

4. The International Council for Harmonisation (ICH) has released new guidelines to aid in developing medicines for pregnant populations. These guidelines emphasize the need for robust clinical data to assess drug safety and efficacy during pregnancy. Additionally, they provide updated recommendations for presenting quality information in the Common Technical Document (CTD).
Source: bit.ly/43jxTmn

5. The European Medicines Agency (EMA) is promoting faster global timelines for post-approval changes (PACs) through regulatory reliance, allowing non-EU countries to use EMA’s assessments. This reduces duplication, speeds up approvals, and improves patient access. Companies must clearly communicate PAC submissions and inform EMA when sharing data with other regulators to ensure smooth coordination.
Source: bit.ly/4jv8rzh