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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 Government has notified Extended Producer Responsibility Rules for non-ferrous metal waste, effective April 2026. Applicable to pharma, food, and consumer goods sectors, these rules mandate registration, traceability, annual returns, and recycling targets to boost circular economy efforts and environmental compliance.
Source: bit.ly/4loNjMw

2. The Customs, Excise & Service Tax Appellate Tribunal (CESTAT), New Delhi, recently ruled that HIV viral load (HIV VL) test kits constitute “life saving diagnostic kits,” making them eligible for customs duty exemption. This landmark decision is poised to reduce import costs, boost accessibility, and support public health initiatives within India.
Source: bit.ly/3GmAVxA

3. The panel set by the Drugs Controller General of India has reportedly recommended a complete ban on cosmetics containing more than 1 part per million (ppm) of mercury, aligning with the Minamata Convention. The Central Drugs Standard Control Organisation will enforce self declarations and random lab testing to protect public health.
Source: bit.ly/401j99Q

4. The Delhi High court has directed the Drug Controller General of India (DCGI) to review the approval and sale of weight loss drugs like Semaglutide, Tirzepatide, and Liraglutide. Responding to a PIL citing safety concerns and lack of India specific trials the court ordered expert consultations and a detailed report within three months.
Source: bit.ly/3IaT69X

5. The Madras High Court of India has held that the Customs Department is legally bound by the Director General of Foreign Trade’s classification of capital goods under the Export Promotion Capital Goods (EPCG) Scheme. This ruling provides clarity for exporters and importers by ensuring uniform interpretation of capital goods classification under the Foreign Trade Policy.
Source: bit.ly/4ldsFyZ

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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 Food authority (FSSAI) has extended the validity of No Objection Certificates (NOCs) granted to imported alcoholic beverages bottled at origin or in bulk with over 10% alcohol content and with no expiry date to 365 days. If consignments remain in Customs premises beyond this period, re-validation can be done through visual inspection upon payment of a prescribed fee.
Source: bit.ly/44Lgsvu

2. India’s Drugs Consultative Committee (DCC) has reportedly proposed enabling the licensing of Bedaquiline, Delamanid, Pretomanid, and Rifapentine only through India’s National Tuberculosis Elimination Programme (NTEP), with strict label warnings. This move aims to prevent misuse, preserve drug effectiveness, and combat rising cases of drug resistant tuberculosis.
Source: bit.ly/4km2dC7

3. The National for Allied and Healthcare Professions (NCAHP) has recommended replacing the term “Paramedical” with “Allied and Healthcare” across all government and institutional communications (verbal, written or electronic). States, UTs, and relevant bodies must implement and enforce this updated terminology in all official usage.
Source: bit.ly/4ltTcYA

4. A popular U.S. snack brand will remove “100% natural” claims from its packaging after lawsuits highlighted trace herbicide residues in its ingredients. Although levels were within legal limits, consumer groups argued the label was misleading.
Source: bit.ly/3TlDeE4

5. The U.S. Food and Drug Administration (FDA) has issued warning letters to four entities, including an Indian drug manufacturer, citing violations such as non-compliance to clinical trial protocol, insanitary conditions, contamination risks, and inadequate donor screening. The FDA has directed them to implement corrective actions to ensure compliance and safeguard product quality.
Source: bit.ly/44aoWw8
Source: bit.ly/45S8eD4
Source: bit.ly/4nqNn01
Source: bit.ly/45Sv11E

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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. Medical device companies have raised concerns over Uniform Code for Marketing Practices for Medical Devices (UCMPMD) and have approached the Department of Pharmaceuticals, citing overreach and operational challenges, particularly in the context of a DGHS advisory that restricted medical representative’s interactions with HCPs in government hospitals.
Source: bit.ly/3InfXiu

2. India’s Central Drugs Standard Control Organisation (CDSCO) is working on making drugs/medicine packaging more readable. The move aims to improve visibility of key details like expiry dates and dosages, addressing concerns over hard-to-read glossy labels. Proposed measures include clearer print standards and digital aids such as voice-enabled QR codes and Braille cards to enhance accessibility and consumer safety.
Source: bit.ly/46oMIpA

3. India’s Drugs Consultative Committee (DCC) has agreed to amend the Drugs Rules, 1945, to include Good Distribution Practices (GDP) guidelines for pharmaceutical products as a separate schedule. The decision follows detailed deliberations and stakeholder consultations to align with revised WHO guidelines.
Source: bit.ly/4lxABuC

4. The U.S. FDA is reportedly planning to revise the labeling for all extended-release stimulants prescribed for attention-deficit hyperactivity disorder (ADHD), requiring inclusion of a “limitation of use” section with a statement on higher rates of adverse reactions in children younger than six years.
Source: bit.ly/4l2REoA

5. The European Commission has amended its regulation to allow electronic instructions for use (eIFUs) for all medical devices intended for professional use, not just high-risk ones. Paper instructions are still required if the device could also be used by patients. eIFUs must be linked in Eudamed (the European medical device database).
Source: bit.ly/4lcdMx1

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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. Food Safety and Standards Authority of India has mandated complete inspection of all packaged drinking water facilities in Maharashtra amid hygiene scare. The move entails bi-annual compliance checks across production units to ensure that all such facilities comply with food safety norms.
Source: bit.ly/4lA3LcQ

2. The Ministry of Environment, Forest and Climate Change has extended the deadline for filing annual returns by Producers, Importers, and Brand Owners (PIBOs) of plastic packaging for 2024–2025 to July 31, 2025 from June 30, 2025 as a special case. This aims to ease compliance and ensure effective plastic waste management.
Source: bit.ly/4nrkbG3

3. India’s Mumbai District Consumer Disputes Redressal Commission has held a leading biscuit manufacturer and its retailer liable for selling fungus-contaminated biscuit packets, despite the products being within their expiry date. They were directed to compensate the consumer and cover legal costs, reinforcing accountability in food safety and consumer rights.
Source: bit.ly/3GkOPjH

4. A conflict has emerged between Telangana’s Medical and Dental Councils over dentists performing hair transplants and aesthetic surgeries. The Indian Medical Council cites National Medical Commission guidelines limiting such procedures to trained dermatologists or plastic surgeons, while the Dental Council asserts that qualified Oral & Maxillofacial Surgeons are permitted and qualified under existing dental regulations to perform such procedures.
Source: bit.ly/3I9HO5L

5. India’s Food Safety and Standards Authority of India (FSSAI), is working to set clear guidelines for genetically modified (GM) foods. This move has raised concerns among some organizations about food safety and environmental impact. At the same time, the US is urging India to ease rules on GM crop imports, creating debate over consumer health, agricultural practices, and international trade standards.
Source: bit.ly/4l6Nlsk

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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 (MoHFW) is reportedly planning to integrate India’s Rare Donor Registry (RDRI) with the e-Rakt Kosh portal to streamline access to rare blood types like Bombay and Rh-null. This move connects over 4,000 rare blood donors with hospitals nationwide, improving response time and ensuring safer transfusions for patients with conditions like thalassemia and sickle cell disease.
Source: bit.ly/3HS9IDi

2. India’s Central Drugs Standard Control Organisation (CDSCO) has flagged 128 drug batches as Not of Standard Quality (NSQ) in its May 2025 alert. The list includes common medicines like paracetamol, dapagliflozin, dexamethasone, and others. Issues cited include assay failures, content non-uniformity, sterility, and misbranding. The alert aims to safeguard public health by informing stakeholders and enabling swift regulatory action.
Source: bit.ly/45wqAt3

3. Indian Council of Medical Research – National Institute of Immunohaematology has developed a low-cost, rapid test kit for Hemophilia A and Von Willebrand Disease. it will reduce the healthcare cost significantly and could become a worldwide solution for early diagnosis and treatment.
Source: bit.ly/4k5H4vR

4. A major eyewear company admitted before the Delhi High Court that it mistakenly used another company’s registered trademarks but had no intention of infringing them. The company removed all references. The court accepted this, recorded the admission, and issued a binding decree, formally closing the trademark-infringement case.
Source: bit.ly/43X8tvh

5. India’s Health Ministry has proposed including liver and heart transplants under the Ayushman Bharat PM-JAY insurance scheme, following recommendations from NOTTO (National Organ and Tissue Transplant Organization). Currently, only kidney transplants are covered, making life-saving procedures more accessible and affordable.
Source: bit.ly/4eePwYt

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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 West Bengal Legislative Assembly has passed a new Bill which is an amendment to the Clinical Establishments Act, 2017. The new Bill empowers the State to regulate treatment costs in private clinics, enforce fixed and package rates, streamline licensing, and mandate electronic medical records to ensure consumer protection and transparency.
Source: bit.ly/4k87Cg8

2. India’s Consumer Affairs Ministry has reportedly directed edible oil manufacturers and importers to reduce retail prices in order to pass the benefits of the recent import duty cuts to consumers. Although the new rates are in effect, supply chain delays may postpone noticeable price reduction until late June.
Source: bit.ly/3I5h5Hm

3. Federation of Indian Pharmacist Organizations (FIPO) has urged the Union Health Ministry to reject Drug Technical Advisory Board’s draft permitting sale of 16 OTC drugs (like paracetamol, clotrimazole) through unlicensed outlets without pharmacist oversight, citing risk to public safety.
Source: bit.ly/4kNtMoO

4. The 20 Nifty Pharma firms held a record ₹48,913 cr in cash as of March 31, doubling FY20 levels, and added over ₹10,200 cr in FY25. The cash reserves are aimed at funding M&A, expanding into complex therapy areas to transition into higher-margin, innovation-driven sectors.
Source: bit.ly/4kRGMdg

5. The U.S. FDA has launched a pilot program to accelerate drug reviews for companies aligned with national health priorities, such as pandemic readiness and essential drug supply. Selected firms will benefit from enhanced FDA engagement and early submissions, expediting approvals without compromising safety standards.
Source: bit.ly/3HQPWrH

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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. Government extends PLI scheme application deadline
The Government of India has extended the application deadline for the Production Linked Incentive (PLI) Scheme aimed at boosting domestic manufacturing of Critical Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs). Eligible entities can now apply until July 4, 2025.
Source: bit.ly/3SXjvKE

2. Draft of ghee fatty acid limits, new cheese powder standards, revised drinking water norms issued by India Food Ministry
India’s Ministry of Health and Family Welfare has released draft amendments to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Key changes include updated ghee fatty acid limits, new cheese powder standards, revised drinking water norms, and additive restrictions. Public comments are invited latest by 4th August, 2025.
Source: bit.ly/4k0CfDP

3. Kerala High Court Bans Single-Use Plastics in Tourist Areas and Public Events
The Kerala High Court has banned single-use plastics in ten major hilly tourist destinations and all public events across the state, effective October 2, 2025. The move aims to curb pollution, mandates water kiosks in tourist spots, and directs strict enforcement by multiple state authorities.
Source: bit.ly/3FY3dhK

4. Essential Drug Prices Surge by Up to 20% Amid Global Conflicts
Essential drug prices in India have increased by 10 – 20% as per a leading drug traders association. Geopolitical conflicts have reportedly disrupted supply chains, leading to shortage of key raw materials like aluminium foil, used in pharmaceutical packaging and has driven up production costs for medicines.
Source: bit.ly/43RDxMM

5. Bombay HC rules treaty can’t override customs law
India’s Bombay High Court has ruled that treaty provisions do not override national customs law unless formally incorporated, affirming the jurisdiction of Indian customs authorities that issued show cause notices for alleged misuse of import exemptions.
Source: bit.ly/4ljpx4t

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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. Directorate General of Foreign Trade (DGFT)Trade Connect ePlatform has reportedly expanded the ‘Source from India’ portal to include all pharma Status Holder exporters with valid IECs. This upgrade enhances global discoverability, boosts buyer-supplier connectivity, and further promotes India’s position as a key player in global pharmaceutical trade.
Source: bit.ly/3Ts7gWt

2. The global pharma market is reportedly shifting toward specialty drugs like biologics and oncology therapies. India, while leading in generics, is investing heavily in biosimilars, innovation, and digital health—strengthening its dual role in high-volume supply and cutting-edge pharmaceutical R&D.
Source: bit.ly/4n6JKvN

3. Association of Southeast Asian Nations (ASEAN) has issued new harmonised guidance for medical device classification and borderline products. The update refines risk categories (A–D), defines ambiguous products, and promotes faster regulatory approvals, supporting pharma-medtech innovators in expanding across the Southeast Asian market.
Source 1 : bit.ly/43P2g4t
Source 2 : bit.ly/3HKZ8xN

4. The Confederation of Indian Alcoholic Beverage Companies has reportedly expressed their concern Maharashtra’s government to revisit its decision to raise excise duty on Indian-made foreign liquor(IMFL), country liquor, and imports by up to 50–85%. Industry leaders warns this could trigger a surge in illicit trade, harm legal sales, and reduce long-term state revenues despite short-term ₹14,000 crore projections.
Source: bit.ly/4jQJ3UN

5. The U.S. Food and Drug Administration (FDA) has finalized guidance to streamline the pre-submission facility correspondence (PFC) process for priority abbreviated new drug applications (ANDAs). By submitting complete and accurate facility information at least 60 days before ANDA submission, applicants can qualify for an expedited 8-month review timeline.
Source: bit.ly/4jRpNq0

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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 Central government has reportedly exempted imported pharmaceutical high-density polyethylene (HDPE) medical-grade plastic from mandatory quality certification under Bureau of Indian Standards regulations to facilitate the production of syringes and IV cannulas and a steady supply of essential products in the healthcare sector.
Source: bit.ly/4ldtUOp

2. The Department of Pharmaceuticals (DoP) has reportedly declined to reveal the names of 30 doctors who accepted ₹1.91 crore worth of foreign trips from major pharmaceutical company. Citing privacy concerns, the DoP resisted disclosing details despite National Medical Commission (NMC) being asked to act. The decision has sparked criticism over transparency and ethical accountability in healthcare.
Source: bit.ly/3G400gp

3. The Karnataka State Pollution Control Board (KSPCB) has clarified that Biomass Briquette/Pellet manufacturing plants do not fall under the scope of the EIA Notification, 2006, which governs environmental impact assessments for specified projects.
Source: bit.ly/4n20u7l

4. The government of India is reportedly tightening oversight of online pharmacies offering rapid deliveries amid concerns over unverified prescriptions, safety, and compliance. A regulatory review is underway to enhance consumer protection and control the proliferation of unregulated digital pharma services.
Source: bit.ly/3G1nDpZ

5. India’s Uttarakhand High Court has quashed a case against a leading Ayurvedic drug manufacturer and its founders over alleged misleading medical advertisements claiming to cure conditions such as diabetes and high cholesterol. The Court cited lack of specific evidence or expert reports to support the allegation that the claims were misleading.
Source: bit.ly/3HZK8vW

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. USA has requested India to remove import duties and relax stringent price controls on medical devices and relax rules on data localization policy with an aim to boost trade between nations.
Source: bit.ly/45hYyBt

2. The Central Pollution Control Board has introduced a step-by-step complaint module for changing login credentials on the Plastic Packaging Extended Producer Responsibility portal, easing access for affected companies.
Source: bit.ly/4e1NJWh

3. India’s Health Ministry mandates purchase invoice billing or provision of CGHS supplied medicines for Central Government Health Scheme claims, squeezing private hospital margins and prompting sector backlash
Source: bit.ly/3HT7nI4

4. Indian pharma companies increasingly deploy blockchain and smart contracts to enhance serialisation, ensure Drug Supply Chain Security Act (DSCSA) compliance, curb counterfeit drugs, automate supplier processes and reinforce production quality and security.
Source: bit.ly/3SRv85J

5. The Ministry of Consumer Affairs has issued further FAQs to provide clarity on the implementation of the Legal Metrology (Packaged Commodities) Rules, 2022. Key clarifications include guidelines on the declaration of MRP, labelling requirements for weighing machine, declaration regarding Institutional sale etc.
Source: bit.ly/440O2w7