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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. General insurers are reportedly urging the Indian Finance Ministry to exempt commissions on health insurance from the 18% GST and reinstate input tax credit (ITC), arguing that commissions part of procurement costs should be treated like reinsurance commissions. Without relief, premiums could increase by ₹3-5 per ₹100 cover, hitting India’s ₹40-50k crore retail health insurance market.
Source: short-url.org/1antS

2. India’s Supreme Court has allowed Major Electronics company to be exempted from customs duty on its G Watch W7 imports from South Korea, even though it was classified under the higher duty category (CTH 8517). The court held that a certificate of origin from a country with which India has a full customs duty exemption agreement is sufficient to claim such exemption.
Source: short-url.org/1anu0

3. India’s Tamil Nadu Medical Council (TNMC) has issued a notice classifying “conversion therapy” as a professional misconduct. It warned that doctors attempting to alter a person’s sexual orientation or gender identity will face strict disciplinary action, including suspension or cancellation of their medical license, reinforcing ethical practice and safeguarding LGBTQIA+ rights across the medical community.
Source: short-url.org/1anvQ

4. Private hospitals in India are locking horns with insurers over reimbursement rates and delayed settlements as medical inflation surges. Some renowned hospitals have suspended cashless services in August. Policyholders are bearing the financial burden amid this impasse.
Source: short-url.org/1anuR

5. The Supreme Court ruled that under the NDPS Act, failure to produce the bulk of seized contraband at trial doesn’t fail the prosecution’s case, provided inventory, sample-drawing and forensic report are properly documented. The court emphasized that only in exceptional cases, where procedural breach undermines the case’s core, should retrial be ordered.
Source: short-url.org/1anv0

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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 Maharashtra Medical Council is set to launch a portal to register homeopathy practitioners who hold a one-year “Certificate Course in Modern Pharmacology” (CCMP), per government directive. Doctors’ groups have opposed this by stating that this move undermines MBBS standards, risks public health, and have demanded the notification’s immediate withdrawal.
Source: short-url.org/1eGvx

2. A renowned hospital has launched a ‘Living Will Clinic’ to help terminally ill patients document their medical preferences when recovery is not possible. Patients can predefine interventions like ventilation, CPR, surgery or home-vs-hospital death, appoint a healthcare representative, during critical moments.
Source: short-url.org/1eFVl

3. Computer Emergency Response Team – India (CERT-In) has mandated annual cybersecurity audits for all MSMEs starting September 1, 2025. Key mandates include, establishing a minimum security baseline, reporting incidents within six hours, keeping 180-day system logs, conducting yearly vulnerability assessments, and providing regular employee cybersecurity training.
Source: short-url.org/1eFVu
Source: short-url.org/1a5Na

4. The Delhi government has decided to establish a special committee under the Health Department to suppress the sale of counterfeit medicines across the city. Four specialised teams will conduct midnight raids especially near hospitals and medical shops. Seized drugs will go through laboratory testing to confirm authenticity.
Source: short-url.org/1a5Gx

5. Drug Controller General of India has directed state authorities in Gujarat and Delhi to take action against drug marketers associated with manufacturers who failed risk based inspections. Labels in some cases listed marketers with invalid addresses. Actions may include cancelling licences, stopping production, suspending product permissions however, it may disrupt the medical supply.
Soruce: short-url.org/1aatp

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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 Consumer Affairs Ministry has permitted manufacturers, packers, and importers to revise MRPs on unsold pre-packaged goods post-GST changes, reflecting only the tax difference. Original MRP must remain visible. Revisions via stickers or stamping are allowed. Conditions include newspaper ads, dealer notifications, and apply until December 31, 2025, or stock exhaustion which ever is earlier.
Source: short-url.org/1dU94

2. The Department of Consumer Affairs has proposed an amendment to the Legal Metrology (Approval of Models) Rules, 2011, introducing a validity period of 10 years for domestic and 5 years for imported model approvals. Public comments are invited before October 9, 2025 through emails.
Source: shorturl.at/7wExv

3. The Soybean Processors Association of India has reportedly objected to FSSAI’s ‘Eat Right India’ post promoting olive oil, calling it elitist and biased. They argue it undermines public confidence in affordable, nutritious local oils like soybean and mustard, and urge its withdrawal to protect consumer trust and national interests.
Source: shorturl.at/zkeaL

4. The FSSAI has constituted a committee to modernize India’s organic-food and agricultural products’ regulatory framework by revising certification rules, usage of the India Organic label, and aligning standards with global benchmarks. While the scope spans organic agricultural products, the authority has not provided a timeline for rollout.
Source: shorturl.at/AQnA5

5. The Retail Distribution Chemist Alliance (RDCA) has cautioned that the shift reducing GST on most medicines from 12% to 5%, effective September 22, 2025, is financially unviable for pharmacies due to unrecoverable input tax credit, risking severe medicine shortages without urgent relief.
Source: shorturl.at/oAEhB

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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 Corporate Affairs has broadened fast-track merger eligibility to include more unlisted firms and companies with debt under INR 100 crore and no defaults, as well as mergers involving holding companies and their unlisted subsidiaries even if not wholly owned streamlining consolidation and ease-of-business push.
Source: shorturl.at/viKVh

2. India’s Ministry of Health and Family Welfare has proposed amendments to the New Drugs and Clinical Trials Rules, 2019, expanding provisions for test licenses. The draft mandates prior permission or notification for manufacturing investigational drugs for trials, bioavailability/bioequivalence studies, and analysis and excludes sensitive categories sex hormones, cytotoxics, beta-lactams, biologics with live microorganisms, and narcotic/psychotropic substances from the simplified notification pathway.
Source: short-url.org/1dQTc

3. The Karnataka Pharma Retailers & Distributors Organization (KPRDO) urged reconsideration of a new 24×7 medicine delivery service via a quick commerce platform, citing conflict with longstanding pharmacy owners, regulatory hurdles amid a Delhi High Court injunction banning online medicine sales, and risks of drug misuse via teleconsultations.
Source: shorturl.at/lldc0

4. Drug regulators from five northern states reportedly met in Chandigarh to address counterfeit and psychotropic drug threats. They agreed to form an interstate coordination committee, adopt a unified tracking portal, conduct surprise inspections, implement SOPs, and strengthen cross-border enforcement through stricter legal and regulatory actions.
Source: shorturl.at/NG50D

5. The Supreme Court has refused to entertain a plea challenging the legality of declaring individuals as “brain dead” under the Transplantation of Human Organs and Tissues Act, 1994. The Court emphasized that the determination of brain-stem death is a matter of legislative policy and declined to question its validity.
Source: shorturl.at/MPWKA

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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

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. 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