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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 (NPPA) has directed all manufacturers, importers, and marketers of non-scheduled drugs and medical devices to cap MRP increases at 10% over the preceding 12 months. Violation of this directive, issued under the Drugs Price Control Order 2013, will invite penal action under relevant laws.
Source: bit.ly/3GIUvEu

2. The Food Safety and Standards Authority of India (FSSAI) had issued a notification mandating 100% inspection of all packaged drinking water units in Hyderabad and across state of Maharashtra, deploying RAFT kits and mobile labs. The move classifies bottled water as “high-risk,” requiring annual or bi-annual audits, tighter quality checks to ensure product safety, and enforce immediate corrective actions through intensified inspections and enhanced stakeholder awareness.
Source: bit.ly/4o0HYwZ

3. The Health Ministry has linked the Kayakalp scheme with National Quality Assurance Standards certification. Hospitals must apply for state level NQAS certification within three months of receiving Kayakalp results to get incentives, ensuring a direct shift from cleanliness efforts to comprehensive healthcare quality and patient safety.
Source: bit.ly/4lJv0Sr

4. India’s Union Health Ministry has clarified that states and UTs bear primary responsibility for implementing passive euthanasia and living wills within hospital protocols and, must establish ethical safeguards as per Supreme Court guidelines. States are also tasked with training healthcare professionals to respect patients’ end of life choices and simplify advance directive procedures
Source: bit.ly/44TTG3q

5. Uttar Pradesh Health Department is reportedly set to digitally deliver medical test reports directly to patients’ mobile phones, via WhatsApp, SMS, and the Personal Health Record portal. The system aims to connects district and community health center hospital management information systems with Laboratory information systems under the Ayushman Bharat Digital Mission.
Source: bit.ly/3TWuvZa

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 (MoEF&CC) has extended the deadline for filing Annual Returns under the Battery Waste Management Rules, 2022 until 30 September 2025. The previous deadline for filing of Annual Returns was 30 June 2025.
Source: bit.ly/46qdfmG

2. The Indian Government is reportedly set to enforce a Minimum Import Price (MIP) on approximately 10 critical pharmaceutical raw materials including Key Starting Materials (KSMs), Active Pharmaceutical Ingredients (APIs), and drug intermediates used in antibiotics and cholesterol medicines primarily imported from China
Source: bit.ly/3II4D0P

3. The Union Health Ministry is reportedly recommended to remove wholesale licensing requirement for household liquid antiseptics by reclassifying them separately from stronger, hospital-grade variants. This aims to make these products more affordable and widely available in retail stores.
Source: bit.ly/3GEEJdP

4. The Department of Biotechnology (DBT) is inviting proposals to establish Image Informatic Centres aimed at creating AI-powered imaging biobanks. These centres will collect and annotate diagnostic images linked with clinical data to develop AI algorithms for improved disease diagnosis and precision medicine.
Source: bit.ly/3GWmVuG

5. India’s Supreme Court has directed the central government to provide an office space within four weeks for the National Task Force (NTF) set up to address the mental health crisis among students, particularly in medical and higher education institutions. The NTF has faced hurdles in functioning due to the lack of physical infrastructure.
Source: bit.ly/44JT1mr

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 added the National Human Rights Commission (NHRC) to a 2018 PIL enforcing the Mental Healthcare Act, 2017. It condemned inhumane practices like chaining mentally ill patients, noted failure to set up mental health authorities and review boards, and directed the Centre to file a detailed affidavit on steps taken to implement the Act nationwide.
Source: bit.ly/4lB9e3f

2. Indian government has initiated a formal investigation into the growing import of medical devices from China, targeting potential cybersecurity and patient data privacy threats. Rising imports across diagnostics, surgical instruments and IoT enabled monitoring systems have raised concerns over malware, or data misuse, prompting scrutiny from commerce and health authorities.
Source: bit.ly/3IFimWg

3. The Indian Council of Medical Research (ICMR) has issued an Expression of Interest inviting eligible organisations, companies and manufacturers for transfer of technology for commercial production of recombinant multi stage malaria vaccine, AdFalciVax, by August 17, 2025.
Source: bit.ly/4eWGiAi

4. The Delhi government plans to exempt restaurants and eateries from obtaining the mandatory health trade license from the Municipal Corporation of Delhi (MCD). Currently, obtaining this licence is a prerequisite for opening eateries in the city.
Source: bit.ly/46ld2B6

5. Delhi High Court has temporarily barred pharmaceutical company from manufacturing, selling importing, exporting or dealing a biosimilar of patented cancer immunotherapy drug after finding credible evidence of patent infringement and potential irreparable harm.
Source: bit.ly/46Vlkjh

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 central drug regulator (CDSCO)has issued a Subject Expert Committees (SEC) guidance document 2025, which outlines a structured process for evaluating clinical trial and new drug applications. It covers SEC composition, review timelines, quorum, waiver criteria, applicant obligations, and decision protocols to ensure scientific rigor, transparency, and regulatory consistency.
Source: bit.ly/4f2ICpE

2. The Central Pollution Control Board has extended the timeline for filing quarterly and annual E Waste returns for the financial year 2024–25 from June 30, 2025 to August 15, 2025. All registered entities must submit return via the E Waste EPR Portal to avoid penalties under the Environment Protection Act, 1986.
Source: bit.ly/44V6tCM

3. India’s Bureau of Energy Efficiency has issued the Draft Appliance Labelling Regulations, 2025, alongside a repeal order for thirteen earlier label-display regulations affecting appliances like refrigerators, ACs, TVs, washing machines, transformers, lamps, and fans. Stakeholder feedback is invited until August 10, 2025.
Source: bit.ly/4f7if1F

4. The Government of India is being urged by experts and the Thalassemia Patients Advocacy Group (TPAG) to mandate Nucleic Acid Testing (NAT) in all blood banks to detect HIV, Hepatitis B, and C during the early “window period.” The call highlights existing gaps in blood safety, with demands for Ministry of Health action amid rising concerns over patient rights and transfusion-linked infections.
Source: bit.ly/3GXeQpo

5. Advisory panel of US Food and Drug Administration has reportedly recommended removing the strong black box warning from vaginal estrogen products, saying it’s based on outdated data that scares women and doctors. Experts highlighted benefits like heart attack and bone fracture prevention. The FDA has yet to make a final decision.
Source: bit.ly/44DSh2j

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 has issued the first amendment to Food Products Standards & Food Additives Regulations, introducing norms for meat sausages, dehydrated tarragon, changes in packaged drinking water specifications, and revisions to food colour and additive rules. The regulations take effect from 1 February 2026.
Source: bit.ly/44C2uMH

2. The Supreme Court of India has recently ruled that stem cell banking including enrolment, collection, processing, and storage of umbilical cord blood qualifies as a healthcare service. It held that such services support preventive and therapeutic care, and are therefore exempt from service tax.
Source: bit.ly/3Ixa7eK

3. India’s Central Drug Authority (CDSCO) has released a guidance document outlining the process for manufacturers to obtain a No Objection Certificate (NOC) for exporting unapproved or approved new drugs. Key updates include mandatory online applications, one-time registration valid for a year, detailed reconciliation and a 7-day NOC issuance timeline.
Source: bit.ly/4kLR6CO

4. India’s Women & Child Development Ministry has issued an advisory to states urging them to curb edible oil usage amid rising obesity and non communicable diseases. It also reiterates previous guidance to limit added salt, sugar, and synthetic additives in Anganwadi nutrition provisions.
Source: bit.ly/4m37IH3

5. In India–EU trade negotiations, the EU seeks substantial tariff reductions on medical devices, automobiles, wine, spirits, meat, poultry, and stronger IP protections. Automotive and med tech duties currently up to 10% are in focus. India is pushing for reciprocity, including non tariff barrier reductions under phased FTA talks.
Source: bit.ly/4lZN8Hu

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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 Drugs Standard Control Organisation has notified that all WHO GMP (COPP) applications be submitted exclusively via the ONDLS portal, effective from 15th August, 2025 and that physical submission will no longer be accepted after this date. This deadline, initially set for 15th July, 2025, was extended by a month due to stakeholder challenges with uploading the documents on the portal.
Source: bit.ly/4eTVL4e

2. The Union Health Ministry and PIB have dismissed reports claiming mandatory warning labels on samosas, jalebis, laddoos, and similar snacks, calling them misleading and baseless. The real advisory pertains to general dietary awareness, not targeting street foods.
Source: bit.ly/46Kaqwz

3. The Delhi High Court has held that the defendant’s ORSL mark is deceptively similar to the plaintiff’s ERSI mark according to the triple identity test as the marks, products (oral rehydration solutions), and trade channels are identical.
Source: bit.ly/44UUSDP

4. The Delhi High Court has granted interim relief in favor of Jio and Reliance by ordering major e-commerce platforms to temporarily delist listings from 21 sellers who have been offering counterfeit Fast-Moving Consumer Goods (FMCG) under the “Reliance” and “Jio” trademarks.
Source: bit.ly/44LrMql

5. Indian Council of Medical Research- National Institute for Research in Reproductive and Child Health (ICMR-NIRRCH) is reportedly launching EndoCare India, a multidisciplinary care model for disorders like endometriosis, fibroids, polycystic ovary syndrome and chronic pelvic pain.
Source: bit.ly/3GQQPAp

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 Medical Commission has directed all medical colleges to form and register adverse event monitoring committee chaired by the medical superintendent under the Materiovigilance Programme with Indian Pharmacopoeia Commission to monitor, assess and prevent adverse events from medical devices by July 31, 2025.
Source: bit.ly/3TI4mxc

2. The Maharashtra government paused its decision to let homeopaths prescribe modern medicine, forming a 7-member committee to review the issue within two months. The move comes amid strong opposition from medical associations concerned about public safety and standards. The matter remains pending in Bombay High Court.
Source: bit.ly/4lYxuMI

3. India’s Ministry of Environment, Forest and Climate Change has notified the Environment (Protection) Fourth Amendment Rules, 2025, introducing revised emission norms for thermal power plants. Based on plant categorization, sulphur dioxide emission standards have been prescribed, along with timelines and penalties for non-compliance, including environmental compensation.
Source: bit.ly/40iWJRx

4. The District Consumer Commission in Ernakulam, Kerala, found a fertility clinic guilty of unfair trade practices and service deficiency for giving misleading assurances about IVF success rates. The Commission awarded ₹2.66 lakh in compensation the couple, emphasizing that such conduct is a breach of duty owed to consumers, violating their right to truthful information and fair services.
Source: bit.ly/4lzmghO

5. The recently signed “One Big Beautiful Bill” introduces stricter Medicaid work and eligibility verification from 2027, in addition to funding cuts that may force insurers to exit low-margin markets. The Congressional Budget Office warns this could leave 7.8 million Americans uninsured by 2034, while driving up premiums and administrative burdens.
Source: bit.ly/4ls9HEN

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 central drug authority has launched a new CT 04 application module on its SUGAM online portal, streamlining the issuance of import licences for cell & gene therapeutic products to simplify and accelerate regulatory compliance and imports.
Source: bit.ly/3TGuNmR

2. A Central Drugs Consultative Committee panel has noted consumer complaints over unreadable expiry dates, tiny fonts, glossy packaging, and generic-brand confusion on medicinal products. It recommends forming a DCGI-led sub committee including a packaging expert to overhaul labelling norms and evaluate regulatory requirements for packaging suppliers under Drugs Rules, 1945.
Source: bit.ly/3IpVF8h

3. Food Safety and Standards Authority of India (FSSAI) has recently directed licensing authorities to audit annual returns filed by food business operators on the FoSCoS platform. Authorities have been directed to flag inconsistencies, permit revisions via updated portal features, and enforce penalties for false declarations.
Source: bit.ly/4lpGH0p

4. The Central Board of Indirect Taxes and Customs has mandated that customs officers verify the registration of plastic raw material importers on the Centralized Extended Producer Responsibility (EPR) Portal before clearing consignments. This directive aligns with the Plastic Waste Management (Amendment) Rules, 2024.
Source: bit.ly/3TYREu9

5. The Government of India has reportedly planned to transfer the National Health Claims Exchange (Insurance claims platform) from the health ministry to the finance ministry under Insurance Regulatory and Development Authority’s oversight to combat inflated hospital bills for insured patients.
Source: bit.ly/40hID2M

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 High Court has restrained pharma company from using the trademark “Liv 333” for their liver-care product, finding it deceptively similar to established registered trademark “Liv.52” from 1957. The court noted that merely adding numerals doesn’t eliminate consumer confusion.
Source: bit.ly/44lGKV5

2. In the dispute over Geographical Indication between Chile and Peru over the alcoholic beverage “Pisco”, the Delhi High Court ruled that both nations have legitimate claims and no exclusive rights can be claimed, therefore, in order to prevent consumer confusion, each must use geographic labels, “Peruvian PISCO” and “Chilean PISCO”.
Source: bit.ly/4nJfqYI

3. India’s Food Safety and Standards Authority of India (FSSAI), has warned e-commerce platforms to strictly comply with food safety norms or face action. Key mandates include displaying FSSAI licenses, revealing warehouse details on FoSCoS, training food handlers via FoSTaC, uploading hygiene photos, and showing expiry dates online.
Source: bit.ly/3TsiWsz

4. During a consultation with NITI Aayog, MSME pharma associations sought regulatory and financial support for compliance with revised GMP norms, requesting deadline extensions and infrastructure aid, while the DCGI emphasized strict enforcement and responsibility for upholding quality standards.
Source: bit.ly/40GWTSJ

5. The Indian pharmaceutical sector faces legal and regulatory concerns due to high humidity altering the colour, smell, and taste of medicines, risking non-compliance with quality standards. Experts recommend compressed air dryers to ensure pharmaceutical products meet statutory purity and safety requirements.
Source: bit.ly/4nCEH6v

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 Medical Association (IMA) has challenged the Maharashtra government’s decision allowing homeopaths to prescribe allopathic medicines after six months of certified training, calling it a threat to public health. The IMA has filed a petition in the Bombay High Court, urging an expedited resolution of the matter.
Source: bit.ly/4kl20ip

2. A government panel, the Drugs Consultative Committee (DCC) under CDSCO, has directed State Licensing Authorities not to issue manufacturing licenses for new drugs without prior approval from the Central Licensing Authority (CLA), as mandated by New Drugs Clinical Trial Rules 2019.
Source: bit.ly/3GC8A6l

3. India’s NITI Aayog has setup an expert panel to review quality concerns in India’s pharmaceutical manufacturing. It will assess regulatory gaps and challenges across 3,000 companies and 10,500 units. The goal is to align production with global standards, boost compliance, and ensure patient safety to uphold India’s global medicine supplier status.
Source: bit.ly/3GvWBHB

4. The Drugs Consultative Committee (DCC) has recommended inclusion of detachable Braille cards and voice-enabled QR codes on medicine packaging to enhance accessibility for visually impaired patients. The proposal aims to standardize inclusive labeling across pharma products, aligning with patient-centric and accessibility-first regulatory reforms.
Source: bit.ly/3TttpUw

5. The Drugs Consultative Committee (DCC) has approved amendments to Forms 27D/27DA and 28D/28DA under the Drugs Rules, 1945, enabling manufacturers to apply for licenses to produce stem cell-derived, gene therapy, xenograft, and modified-release products via both state and central authorities.
Source: bit.ly/3Ii5o0f