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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. 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. 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

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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 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

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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. Health Ministry’s proposal to amend the Drugs and Magic Remedies Act, aimed at curbing misleading medical advertisements, has been stalled since year 2022. The outdated Act allows deceptive ads, especially in AYUSH and modern medicine sectors, to persist unchecked has been revealed by an RTI.
Source: bit.ly/4kvddgY

2. Karnataka Government has suspended all Jan Aushadhi Kendras inside government hospitals, ensuring patients receive all medicines free of cost from hospital pharmacies. Kendras outside hospitals will remain open.
Source: bit.ly/4dtDZE2

3. GS1, the non-profit standards organisation is set to replace traditional barcodes with advanced 2D bar code technology by 2027 to improve product traceability, safety, and transparency, allowing consumers and businesses to access key details like origin, expiry, and recall information with one scan.
Source: bit.ly/45ahMsP

4. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is enhancing its Manufacturer’s Online Reporting Environment (MORE) to improve medical device safety. Effective June 16, 2025, manufacturers must submit Manufacturer Incident Reports (MIRs) and Field Safety Corrective Actions (FSCAs) through the updated MORE platform. The changes aim to strengthen post-market surveillance and facilitate better risk management
Source: bit.ly/3SRvQje

5. US Government is pressing India for tariff reductions on medical equipment as part of ongoing bilateral trade negotiations. After the US imposed a steep 26% tariff on Indian medical device exports in April 2025 up from previous rates of near-zero to 6%. India is seeking full exemption from these duties, which have been temporarily suspended for 90 days until July 9.
Source: bit.ly/4kv9WOu

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 Punjab & Haryana High Court mandates state government to notify rules under Mental Healthcare Act, 2017 within 60 days, addressing a 7-year delay that hampers effective implementation and delivery of mental health services.
Source: bit.ly/4k3CEpU

2. India’s Central Drugs Standard Control Organisation (CDSCO) has issued a guidance document outlining the procedure for obtaining a Free Sale Certificate (FSC) for licensed medical devices in India. It simplifies the regulatory process for submitting an application and obtaining the FSC from the Central Licensing Authority.
Source: bit.ly/3FbKQW9

3. Food Safety and Standards Authority of India (FSSAI) mandates that FBOs with expired licenses or registrations in FY 2024–2025 must submit a Closure Report via the FoSCoS portal. The report must confirm no ongoing business or provide details of a new license. Reasons for non-renewal must be stated to ensure transparency and traceability in licensing.
Source: bit.ly/3Se67kQ

4. India’s Department for Promotion of Industry and Internal Trade (DPIIT) has extended the implementation of the Quality Control Order (QCO) for household and commercial electrical appliances to March 19, 2026. The update includes relaxations for Micro, Small and Medium Enterprises, R&D and export units, supporting quality and ease of business.
Source: bit.ly/4ksMTEb

5. The Drugs Control Department of Kerala has taken an action against a private hospital for illegally stocking and selling Physician’s sample medicines at inflated prices, highlighting that sample medicines can neither be stocked nor sold by hospitals.
Source: bit.ly/3FieSaJ

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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

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 Supreme Court has ruled that volume-based discounts are lawful and do not constitute discriminatory pricing, for such discounts to be considered discriminatory they must be applied unequally to similarly situated buyers in comparable transactions.
Source: bit.ly/4mghWEN

2. India’s Supreme Court has issued a notice to the central government on a petition seeking to make it mandatory for hospitals and clinical establishments to display service rates and charge fees within limits set by the Centre, in consultation with state governments. The Court noted that the failure to enforce this requirement stems from the government’s failure to specify the service charge limits which potentially impacts citizens’ fundamental right to healthcare.
Source: bit.ly/4jXJ75U

3. The High Court of Jammu & Kashmir and Ladakh has upheld a government advisory requiring retail and wholesale pharmacies to install CCTV cameras and adopt computerized billing systems. This measure aims to curb the sale of prohibited drugs and enhance transparency in pharmaceutical operations.
Source: bit.ly/4mgjrCV

4. In a proposed Free Trade Agreement with the UK, India has reportedly decided to reduce import duties on medical devices under the Production-Linked Incentive (PLI) scheme starting only from the sixth year. This phased approach aligns consumer needs with the Make in India programme, aiming to protect domestic manufacturers while gradually opening market access for UK exporters.
Source: bit.ly/4mlyPy8

5. The U.S. government’s order to align domestic drug prices with global rates may impact Indian pharmaceutical firms, many of which rely heavily on U.S. revenues. Though primarily targeting Big Pharma, the move could subject Indian generic manufacturers to pricing pressure, potentially disrupting their business models and profitability.
Source: bit.ly/4dkH0Xt

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 proposed halting new registrations and the renewal of existing registrations for the manufacturing of certain high-risk foods, such as dairy products and infant nutrition. They have also proposed permitting only state or central licenses and implementing pre-license inspections for manufacturers in these categories. They have sought public feedback on these proposed changes by 30th May, 2025.
Source: bit.ly/3RRy4Po

2. The Bombay High Court directed the state government to consider a separate registration facility for patients who are not yet on dialysis but will soon need an organ transplant. This came after a CKD Stage-V patient was denied registration. The Court said such denial violates the right to life.
Source: bit.ly/3RM4xqh

3. India’s ministry of commerce and industry has prohibited the use of specified antibiotics, antivirals, and antimicrobial medicinal products in fish, shrimp, hatchery operations or any manufacturing, pre-processing and processing unit to prevent antimicrobial resistance and safeguard export quality.
Source: bit.ly/44ZamIz

4. India’s Central Drugs Standard Control Organization (CDSCO) has released the guidelines for the safe disposal of expired and unused medicines by hospitals and the general public. The initiative is aimed at addressing the growing concerns of antimicrobial resistance and minimizing environmental hazards. 
Source: bit.ly/4iOmj7d
Source: bit.ly/4d3ywnf

5. Under the Stockholm Convention, 40 nations worldwide have agreed to phase out the use of chlorpyrifos, a hazardous pesticide on food crops. However, India secured a five-year exemption for its use on 12 essential crops to manage certain pests and termites, as well as the lack of immediate alternatives.
Source: bit.ly/4iL0q8M