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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 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 The United States Food and Drug Administration (US FDA) issued draft guidance and a proposed order outlining documentation for minor dosage form changes in highly soluble, highly permeable OTC monograph drugs.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

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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 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

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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 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

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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. 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

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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 proposed prohibiting the import, manufacture, sale, and distribution of certain specified antimicrobial medicinal products for animal use. It has invited public suggestions and objections from stakeholders by 22nd June 2025. The move aims to curb antimicrobial resistance and protect human health.
Source: bit.ly/4dvRgfj

2. The Supreme Court of India recently upheld dual taxation on broadcasting services, allowing both the Centre to levy service tax and states to impose entertainment tax. It ruled broadcasting as communication and entertainment as a luxury, confirming constitutional authority for concurrent taxation on cable TV, digital streaming, and OTT platforms.
Source: bit.ly/4mDyR4G

3. Under the free trade agreement (FTA), the United Kingdom reportedly will provide non-discriminatory access to Indian companies in its public procurement, while India grants UK firms limited access to high-value tenders in return. The deal ensures mutual market access while protecting India’s strategic interests, including ‘Make in India’ and SME support.
Source: bit.ly/3Sm7s9m

4. India and World Health Organisation (WHO) has signed the Memorandum of Understanding (MoU) to include AYUSH therapies in WHO’s global health classification system. This will give traditional medicine scientific recognition, enable insurance coverage, and improve global access to India’s ancient healing systems.
Source: bit.ly/3FuRgQ8

5. India’s Uttar Pradesh government, following a recent hospital fire has mandated comprehensive fire safety upgrades across all hospitals which includes installing fire-fighting systems, conducting regular mock drills, improving ventilation, and ensuring unobstructed evacuation routes. Staff training and adherence to fire safety guidelines to prevent future incidents
Source: bit.ly/45qkb2j

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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. Kerala Deputy Drugs Controller (Ayurveda) has issued a stern warning to a prominent Ayurvedic drug manufacturer, for violating Rule 170 of the Drugs and Cosmetics Rules, 1945. This rule mandates that manufacturers obtain prior approval from state licensing authorities before advertising their products, aiming to prevent misleading promotions of AYUSH drugs.
Source: bit.ly/3H0LSoi

2. The All India Organization of Chemists & Druggists has cautioned against the Centre’s plan to expand the over-the-counter (OTC) drug list, warning that unsupervised use of routine medicines could pose serious health risks and lead to misuse without expert medical guidance.
Source: bit.ly/3H2vB2n

3. Small scale pharma companies have opposed CDSCO’s new export NOC rules, calling them burdensome for them. They warn of losing export markets to competing countries and seek an extension for Schedule M compliance and a tribunal to resolve regulatory disputes efficiently.
Source: bit.ly/3GZoac9

4. Experts have reportedly identified certain fixed-dose combinations (FDCs) in personal care products such as aloe vera, jojoba oil, and orange oil, as irrational and potentially harmful, recommending their prohibition to safeguard public health.
Source: bit.ly/3SGKh9N

5. The U.S. Food and Drug Administration (FDA) is reportedly initiating action to remove from the market unapproved concentrated fluoride drugs for infants and toddlers, citing concerns over microbiome disruption, thyroid issues, weight gain, and possible IQ decline.
Source: bit.ly/4doJeVr

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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 given Central government three months to enforce new food labelling rules which require Front-of-Pack-Warning Labels (FoPWL) for Packaged foods containing high level of sugar, salt, and saturated fat content, along with their recommended daily intake (RDA), in bold and prominent font on the front of packaging.
Source: bit.ly/3Eigy3s

2. Gujarat Food and Drug Control Administration has reportedly found fake QR codes on a top pharma brand’s medicine. Over 900 strips were seized in this counterfeit drug racket. A full-scale investigation, raids, forensic checks, and officer training are underway to trace sources and stop illegal supply chains.
Source: bit.ly/4lsuJna

3. A survey across 303 Indian districts reportedly reveals that most side effects among medicines are caused by antibiotics. One in two people reported side effects from allopathy or AYUSH medicines. Experts warn that misuse of antibiotics without prescriptions is rising antimicrobial resistance, posing serious public health concerns
Source: bit.ly/3YsVr5f

4. India’s Gujarat Food and Drug Control Administration (FDCA) has launched India’s first mobile app for licensing allopathic, cosmetic, and Ayurvedic products, issuing over 900 licenses online. The FDCA-mDMLA mobile app boosts efficiency, transparency, and ease of doing business allowing real-time access and digital services.
Source: bit.ly/4i9yvz6

5. China has reportedly approved an amendment to General Requirements for Labels and Instructions of Disinfection Products, which mandates clearer warnings, font size requirements, and restrictions on misleading branding to enhance safety, transparency, and compliance in the disinfection product industry. The amendment is effective from May 1, 2025.
Source: bit.ly/3Ehsx1f

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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 National Pharmaceutical Pricing Authority has announced that all applications for retail price fixation of new drugs in Form I must be submitted through the dedicated online portal, Integrated Pharmaceutical Database Management System (IPDMS 2.0) from April 1, 2025. At present, Form I applications for the retail price fixation of new drugs are being submitted via email.
Source: bit.ly/4i4aKJw

2. India’s small retailers are facing challenges as quick-commerce giants are allegedly engaged in deep discounting  for the products sold through their platform. The All India Consumer Products Distributors Federation has urged the Competition Commission of India to investigate these discounting pricing practices.
Source: bit.ly/4ixzqtB

3. The Information Technology Industry Council (ITI) urges the government to delay children’s data processing rules under the Digital Personal Data Protection (DPDP) Rules, 2025, as global tech firms are facing operational challenges. They recommend aligning age verification with international standards.
Source: bit.ly/3QQV1l0

4. The Indian Council of Medical Research’s new guidelines exempt Ayush-approved medicines from additional safety evidence from animal studies or phase I/II human clinical trials in integrative research. However, non-codified traditional medicines must undergo full regulatory approval and adhere to applicable regulations.
Source: bit.ly/3QQWkAq

5. The Competition Commission of India (CCI) has ruled that a hospital’s intentional misleading of consumers, involving the misrepresentation of its surgeon’s qualifications and false advertising, does not raise any concerns under the provisions of the Competition Act 2002 and is outside CCI’s jurisdiction.
Source: bit.ly/3Fbvl05

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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 AYUSH has proposed an amendment to the First Schedule of the Drugs and Cosmetics Act, 1940, expanding the list of authoritative books for Ayurveda, Siddha, and Unani Tibb drugs. The updated list now includes more vernacular books with details such as the author’s name and language. These drugs must be manufactured according to the formulae described in the books listed in the First Schedule, as defined by the Act.
Source: bit.ly/40UqMhL

2. The Ministry of AYUSH has proposed an amendment to update the list of poisonous substances in Ayurveda, Siddha, Sowa-Rigpa, and Unani systems under Schedule E(I) of the Drugs Rules, 1945. The draft amendment has been published for public awareness, with a 30-day period for objections or suggestions. The amendment categorizes the poisonous substances by their botanical names and includes the drugs in the respective systems of medicine that are prepared using these substances.
Source: bit.ly/3QdJ6NP

3. India’s drug pricing regulator has directed all retailers and dealers, including online pharmacies, to display the current price list of medicines on their websites. This move aims to empower consumers and ensure they are not overpaying for their medications.
Source: bit.ly/41bnhEY

4. India’s Odisha Registered Pharmacists Association (ORPhA) has expressed disagreement to government’s classification of pharmacists as paramedics, despite the Pharmacy Council of India (PCI) stating they are independent healthcare professionals. The association has urged the health minister to take steps to avoid the classification, highlighting that pharmacists are specialized healthcare professionals who play a vital role in patient care through their expertise in areas like pharmaceutical sciences, pharmacology, and medication therapy management.
Source: bit.ly/3EtSniq

5. India’s central government has imposed a ban on the export of raw human hair valued at less than $65 per kilogram, as per a notification issued by the Directorate General of Foreign Trade (DGFT). The notification stated that the export policy for raw human hair has been changed from “restricted” to “prohibited.” However, exports will still be permitted without restrictions if the Free on Board (FOB) value is $65 or more per kilogram.
Source: bit.ly/4gBVKAU

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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 Maharashtra government plans to amend the Mumbai Nursing Home Registration Rules, 1949, following concerns from the Indian Medical Association (IMA) over the 2021 amendment, which mandated staffing and infrastructure requirements for small hospitals. The new amendments aim to align regulations with industry recommendations to improve infrastructural and staffing feasibility for healthcare providers.
Source: bit.ly/3CFx3G1

2. The European Medicines Agency has set 23rd July 2025 as the date for implementation of updated International Council for Harmonisation (ICH) guidelines on Good Clinical Practises. This latest version of the guidelines encourages the sponsors to design trials that are fit for purpose and sufficient to provide confidence in the trial’s results.
Source: bit.ly/3CG9rky

3. In the 1st half of Financial Year 2025, the National Pharmaceutical Pricing Authority’s (NPPA) overcharging demands from pharma companies dropped sharply, while the number of cases surged by over 50% compared to last year. This reflects a rise in enforcement actions but a decline in penalty amounts imposed.
Source: bit.ly/4jGCGnY

4. The amended version of European Union’s (EU) Medical Devices Regulations, 2017 introduced Section 10a to enhance transparency and availability of medical devices. It mandates early notification of supply disruptions, extends IVD transition periods, enables a gradual roll-out of Eudamed, and imposes new responsibilities on economic operators.
Source: bit.ly/414XApt

5. A Parliamentary Panel has urged the Ministry of Ayush to strengthen regulations for adverse effects reporting and ensure regular post-marketing surveillance of Ayush medicines. It has requested a detailed status report on actions taken to enhance the regulatory framework for reporting adverse effects and ensuring drug safety and efficacy.
Source: bit.ly/4gzfzZP