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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 Central drugs licensing authority has permitted importers and manufacturers of Class C and D medical devices to affix stickers with revised Maximum Retail Price (MRPs) reflecting reduced GST rates which are effective from 22 September 2025. The stickered MRP must reflect the reduced GST, and the changes must be implemented within 3 months from the date of this order.
Source: short-url.org/19uui

2. The Himachal Pradesh High Court held that stocking allopathic medicines without a valid licence amounts to an “offer for sale” under Section 27 of the Drugs and Cosmetics Act. Displaying medicines in a clinic rack was deemed sufficient to establish intent to sell.
Source: short-url.org/1e2Yz

3. Delhi High Court has temporarily stopped the drug regulator (CDSCO) from initiating criminal proceedings against a major online marketplace accused for listing unapproved drugs. The platform contends it functions only as an intermediary and is protected under law.
Source: short-url.org/1e2YG

4. The Orissa High Court has asked the Odisha Government to respond within two weeks to a PIL seeking mandatory use of Individual Donor Nucleic Acid Testing (Individual Donor Nucleic Acid Testing) in all government and affiliated blood banks. The plea argues that the existing NAT-PCR screening is outdated and less effective in early detection of HIV, Hepatitis B, and Hepatitis C infections.
Source: short-url.org/1e32Q

5. A Parliamentary Standing Committee on Finance has called on the Centre to decentralise the Ayushman Bharat-PMJAY scheme by using mobile health units and telemedicine hubs, especially in tribal and hilly regions. The move aims to improve accessibility, strengthen outreach, and ensure coverage penetrates underserved geographies.
Source: short-url.org/1e2YU

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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

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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 Department of Pharmaceuticals has amended the UCMPMD 2024, clarifying valuation of free evaluation samples at stockist price if self-manufactured or average purchase price if sourced externally. Companies in multiple associations may submit disclosures through one, with prior intimation to others and notification to the Department when switching.
Source: short-link.me/18ym-

2. India’s Health Ministry has proposed amendments to the New Drugs and Clinical Trials Rules, 2019, enabling simplified approval for bioavailability and bioequivalence (BA/BE) studies of oral drugs approved in India or select countries, for export purposes. The draft exempts certain drug categories and caps sample size at 48. Stakeholders may submit objections or suggestions by 27 September 2025.
Source: short-link.me/1d3UX

3. Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO) have released draft protocols for evaluating In-Vitro Diagnostics (IVDs) for tuberculosis, including drug-resistant strains. Stakeholders can submit comments by September 7, 2025. Final protocols will be based on this feedback before final clearance is given by ICMR and CDSCO.
Source: short-link.me/18ylZ

4. India’s Punjab and Haryana High Court has ruled that legible medical prescriptions is a fundamental right of patients and doctors must write prescriptions in capital letters until Digitalization. PGIMER Chandigarh’s “Doctor Desk” e-prescription system is expected to be implemented within two years.
Source: short-link.me/18ym7

5. The Ministry of Health and Family Welfare has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019. The proposals reduce approval timelines from ninety to forty-five working days and introduce a simplified notification system for manufacturing certain drugs meant for analytical and preclinical testing.
Source: short-link.me/1d3Vg

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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 state Tamil Nadu has informed the Madras High Court that it is cracking down on illegal organ transplants after a kidney racket surfaced. Licenses of two hospitals were suspended for forged approvals, and reforms have been proposed, including stronger oversight and awareness campaigns. The court is set to review the progress in this matter.
Source: short-link.me/1bV1v

2. India’s Parliamentary Committee has urged an expansion of the Drugs (Prices Control) Order (DPCO) to cover more cancer drugs, noting that many oncology medications remain unaffordable. The panel also recommended regular market assessments, stricter oversight of generic drug quality, streamlined regulatory pathways, and strengthened domestic research to improve access.
Source: short-link.me/1bV1y

3. Months after India halted imports of refurbished medical devices, medical devices companies are reportedly urging limits on such restrictions and seeking inclusion in the government’s Electronics Repair Services Outsourcing (ERSO) pilot to support repair operations. The Medical Technology Association of India (MTaI) warns the ban could impact healthcare access.
Source: short-link.me/1bV1A

4. A parliamentary panel recommends nationwide expansion of palliative care under the National Programme for Palliative Care (NPPC), urging robust outcome indicators to assess quality of life impact. The Committee seeks integration with all hospital levels, insurance schemes, and occupational rehabilitation for survivors.
Source: short-link.me/17sHl

5. Delhi’s Drug Control Department has confirmed that all 48 tested samples of suspected counterfeit cancer medicines met quality standards and were found genuine. As part of ongoing anti-counterfeit efforts, authorities collected a total of 127 samples, with results for the remaining 79 still pending.
Source: short-link.me/1bV1E

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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 Directorate General of Trade Remedies (DGTR) has recommended a three-year safeguard duty on select steel imports, which is expected to hike costs for medical devices using 316L stainless steel (e.g., surgical tools, implants). This could pressure production margins, inflate end-user prices, and strain India’s competitiveness in domestic and export markets.
Source: short-link.me/17nS4

2. A high level inter departmental committee has reportedly commenced drafting rules to regulate the import of refurbished medical devices into India. Presently, imports are only allowed for high-end high value devices that haven’t been phased out overseas, contain no hazardous materials, and have a minimum seven-year residual life.
Source: short-link.me/1bQ2x

3. The Ministry of Health and Family Welfare has formed a national committee to draft guidelines for brain stem death certification, including for children. The expert panel will also develop training modules, certification criteria, monitoring tools, and audit systems to improve organ donation and critical care practices across the country.
Source: short-link.me/17nSk

4. NATHEALTH urges standardizing the GST input slab at 5% for healthcare and enabling input tax credit wherever output GST applies. The move aims to reduce hidden embedded taxes, estimated at 5.5–6% of provider revenue easing cost burdens on hospitals and diagnostic labs.
Source: short-link.me/1bQ2O

5. A parliamentary standing committee has reportedly recommended accelerating the rollout of a single-dose HPV vaccine to strengthen cervical cancer prevention. The panel also urged expansion of oncopathology infrastructure, especially in underserved regions like the Northeast.
Source: short-link.me/17nSB

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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 Supreme Court has ruled against the notification issued by ministry of environment that had initially exempted educational institutions, industrial sheds, and hostels from mandatory environmental clearance under the Environment Impact Assessment 2006 regime. The court affirmed that projects over 20,000 sqm must now obtain prior approval typically from the State Environment Impact Assessment Authority.
Source: short-link.me/1aM5s

2. India’s Central Drugs Standard Control Organization (CDSCO) has reaffirmed that all WHO-GMP (COPP) applications must be submitted exclusively via the ONDLS portal by August 15, 2025. No further extensions will be granted for physical submissions beyond this date.
Source: short-link.me/16m-3

3. The Union Health Minister informed Parliament that India does not maintain central data on medical negligence cases. States handle such cases individually under the National Medical Commission Act, 2019. Calls for centralized tracking were raised, but the government emphasized health is a State subject with existing regulatory mechanisms.
Source: short-link.me/16m-d

4. India’s Department of Consumer Affairs has released draft rules for “Clinical Electrical Thermometers for Continuous Measurement” under the Legal Metrology Act. The draft rules outline metrological, technical, safety, and labelling standards, along with performance limits, testing methods, and manufacturer obligations. Stakeholder comments are invited by August 30, 2025.
Source: short-link.me/16m-f

5. The Mumbai CESTAT ruled that orthopaedic appliances and implants qualify for customs duty exemption under Serial No. 578, clarifying it covers assistive devices, rehabilitation aids, and goods for disabled persons. The tribunal interpreted the notification broadly and stated that the exemption applies to implants as assistive or rehabilitation aids, and not meant solely for disability use.
Source: short-link.me/1aM5T

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 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 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