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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 NPPA has extended the existing ceiling prices for orthopaedic knee implants until November 15, 2025. The earlier deadline was September 15. The extension allows time to review industry representations while maintaining current ceiling prices.
Source: short-url.org/1eQeU

2. India’s central drugs regulator, has introduced a new online provision, effective 11th September 2025 for “Subsequent Importer” applications. It allows companies to import medical devices and in-vitro diagnostics already approved by CDSCO for marketing in India. The initiative aims to simplify approvals, brand approvals, enhance transparency, and reduce processing timelines.
Source: short-url.org/1eQnm

3. India’s central drug authority has classified pharmaceutical cocrystals of approved active substances as new drugs under New Drugs and Clinical Trials Rules, 2019. Applicants must demonstrate superior properties over physical mixtures, with detailed validation, stability, and bioavailability/bioequivalence data. Submissions will be processed like new active substances, requiring full safety and efficacy evidence.
Source: short-url.org/1afgK

4. Pharmaceutical merchant association are reportedly urging India’s government to revise the rule prohibiting the export of pharmaceutical products labelled “For sale in India only.” They claim the regulation has led to substantial losses, hurting global competitiveness, restricting access for overseas patients, and causing market-share losses.
Source: short-url.org/1eQme

5. Reportedly, one of the leading toothpaste maker company in the United States will update its packaging from November 1 under a settlement order, showing “pea-sized” amounts for children under six to promote safe, age-appropriate fluoride use and address concerns that previous images encouraged potentially unsafe overuse by young children.
Source: short-url.org/1afh5

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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 National Pharmaceutical Pricing Authority has ordered drug and medical device importers, manufacturers, and brand owners to revise MRPs from September 22, 2025, in line with GST Council decisions. Firms must issue revised price lists, inform dealers, retailers and consumers about the reduction in GST rates, and publish advertisements, while re-labelling old stocks is optional if compliance at the retail level is ensured.
Source: short-url.org/19LMW

2. Directorate General of Health Services (DGHS) has revoked its earlier order barring physiotherapists from using the “Dr” prefix, after receiving recommendations from the National Commission for Allied and Healthcare Professions (NCAHP) and facing strong objections from professional bodies. The previous directive, said physiotherapists are allied health professionals and not entitled to use “Dr” to prevent misleading patients. DGHS stated the matter requires further examination.
Source: short-url.org/19LN2

3. With new GST rates kicking in from September 22, 2025, FMCG companies are urging the government to allow sales of products in current packaging (with old MRP) but at revised lower prices. They warn that forcing re-packaging could lead to over ₹2,000 crore in packaging waste and major losses across supply chains.
Source: short-url.org/19LNc

4. The Supreme Court has asked all Indian state governments to reply in four weeks about how they are enforcing the Pre Conception and Pre Natal Diagnostic Techniques Act, giving data since May 1, 2015, on prosecutions, acquittals, and appeals, after noting that many acquittals are never challenge.
Source: short-url.org/1ekQ6

5. India’s Union Minister of State for Health has reportedly inaugurated the National Virus Research & Diagnostic Laboratory (VRDL) Conclave 2025, announcing a new portal and protocols for in-vitro diagnostics (IVD) validation. The initiative aims to speed up and simplify validation. India is also expanding VRDL capacity, bio-safety labs, and outbreak surveillance.
Source: short-url.org/19LNy

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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 Government of India has reduced GST to NIL on 36 lifesaving drugs and cut GST on key medical devices and supplies from 18%/12% to 5%, effective September 22, 2025. Pharma and medical device companies must revise MRPs accordingly and comply with pricing norms under The Drugs Price Control Order and anti-profiteering provisions.
Source: shorturl.at/dRaT8

2. CDSCO has announced that Institutional Biosafety Committee (IBSC) approvals will now be sufficient for biopharma companies seeking CT-10 permissions to manufacture test items from Category I and II genetic engineering experiments.
Source: shorturl.at/ACkQm

3. Maharashtra’s Medical Education Department has instructed the Maharashtra Medical Council (MMC) to begin registering homeopathic practitioners who’ve completed the one-year Certificate Course in Modern Pharmacology (CCMP) under a separate registry. The Indian Medical Association (IMA) has strongly opposed the move deeming it risky to public health, and plans to escalate the matter to the Bombay High Court.
Source: shorturl.at/Ge5OT

4. India’s GST Council has reduced the goods and services tax on diagnostic kits, reagents, and medical devices from 12–18% to 5%, effective September 22, 2025. While this lowers the cost base for labs, experts caution that reagent expenses account for only ~20% of diagnostic test costs, so the actual price drop for patients may be a modest 2–5%, depending on providers’ pricing strategies.
Source: shorturl.at/WvZHI

5. CDSCO has introduced a dedicated “Not of Standard Quality” (NSQ) alerts portal on its official website, enabling Industry experts to access real-time updates on substandard drug batches.
Source 1: shorturl.at/oMBXn
Source 2: shorturl.at/J7Pma

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 Council of Medical Research and India’ central drug authority “CDSCO” have released draft standard protocols for evaluating In-Vitro Diagnostic kits for Influenza, SARS-CoV-2, RSV, Malaria, Dengue, Nipah, and other pathogens. Pharma and diagnostics stakeholders can submit comments by 25 August 2025, after which revisions will be minimal before final adoption.
Source: short-link.me/1b0iM

2. India’s Supreme Court has disposed of a plea challenging misleading AYUSH medicine ads and vacated its stay on the omission of a rule which had removed the requirement for state-level pre-approval of Ayurvedic, Siddha, and Unani drug advertisements. With the rule deleted, companies can advertise without state clearance.
Source: short-link.me/16ALo

3. The All India Organisation of Chemists and Druggists has urged the government to ban ultra fast ten minute delivery of high risk prescription medications by quick commerce platforms, citing threats to public health, rising drug misuse, ghost prescriptions, and a disregard for established regulatory safeguards.
Source: short-link.me/1b0iY

4. India’s Health Ministry has launched SHRESTH Index to benchmark and strengthen state drug regulatory systems. The data-driven framework will guide improvements in infrastructure, manpower, digitization, inspections, and grievance redressal. Upcoming measures include expanding the Not of Standard Quality (NSQ) Dashboard to all states as well.
Source: short-link.me/1b0j6

5. India’s public health organisations call for mandatory front of pack warning labels on food items high in fats, sugar, and salt, replacing Indian Nutrition Rating (or Health Star Rating) system. They cite rising diet related deaths and rapid ultra processed food growth.
Source: short-link.me/16ALH

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

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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 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

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 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

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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 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 Ministry of Health and Family Welfare mandates all WHO-GMP (COPP) certificate applications to be submitted exclusively through the ONDS Portal from June 15, 2025. Hard copy submissions will not be accepted. A step-by-step procedure and contact details for support have also been provided.
Source: bit.ly/3HWGXWd

2. CDSCO has informed all states and union territories that a loan license is no longer required for outsourcing sterilization of medical devices, provided the sterilization facility is licensed under MDR-2017. Manufacturers must submit documentation and include the sterilization site’s license number on labels of the device.
Source: bit.ly/44nGKCX

3. The Bombay High Court has issued an interim injunction restraining a company from using packaging, labels, bottles, and trade dress that closely resemble those of an established hair-oil brand. The court found that the packaging was “slavishly copied,” potentially misleading consumers and amounting to trademark infringement and unfair competition.
Source: bit.ly/4kd5DXM

4. The Andhra Pradesh High Court has ruled that under the Narcotic Drugs and Psychotropic Substances Act, 1985, “Ganja” refers only to the flowering or fruiting tops of the cannabis plant, explicitly excluding seeds and leaves when not accompanied by the tops.
Source: bit.ly/4ls1iRl

5. India’s Central Board of Indirect Taxes and Customs (CBIC), following DGTR recommendations, has slapped anti dumping duties for five years on four key chemicals from China—PEDA, acetonitrile, Vitamin A palmitate and insoluble sulfur—to shield domestic pharma, agro and rubber industries, signalling a strategic push to rebalance imports and promote local manufacturing.
Source: bit.ly/4lNeEYX

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 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