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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. Bureau of Indian Standards is reportedly launching a scientific study on plastic food-packaging safety amid escalating temperatures and prolonged food delivery-times across India. The initiative will evaluate practical performance of materials like PET, recycled PET, polycarbonate and laminated films under heat and humidity, and may prompt revisions to the Food Safety and Standards (Packaging) Regulations, 2018 and higher compliance demands for food-delivery platforms.
Source: rb.gy/rl81wz

2. Punjab health authorities have directed all civil and district hospitals and medical colleges to immediately suspend and quarantine all batches of the anti-haemophilia Factor IX concentrate after reports of adverse reactions. The action is a precautionary step while the Punjab Health Systems Corporation (PHSC) conducts laboratory tests to assess the product’s safety and quality.
Source: urli.info/1jkBD

3. India’s Delhi High Court has refused to allow a major consumer health company to sell remaining stocks of an ORS-type beverages, upholding regulatory ban imposed by the Food Safety and Standards Authority of India (FSSAI) on products marketed as oral rehydration solutions without meeting WHO-recommended composition standards or obtaining proper regulatory approval.
Source: urli.info/1jkBP

4. The National Organ and Tissue Transplant Organisation (NOTTO) under the Ministry of Health and Family Welfare has reportedly revised guidelines so that COVID-19 testing is no longer mandatory for asymptomatic organ donors or recipients, except in lung transplant procedures where RT-PCR remains essential.
Source: urli.info/1jkBW

5. The Pharmacy Council of India has reportedly directed state pharmacy councils to submit updated lists of registered pharmacists, including registration validity, email IDs, mobile numbers, etc. by November 30, 2025. The direction follows the July 31 deadline delay and aims to support the Health Professional Registry under the Ayushman Bharat Digital Mission.
Source: urli.info/1jkBz

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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 has notified an amendment the Transplantation of Human Organs and Tissues Rules, 2014. The amendment specifies that in Form 15, under “Corneal Transplantation Centre,” the word “Specular” shall be replaced with “Specular (optional),” making the requirement for specular examination optional.
Source: urli.info/1eoY-

2. The Supreme Court of India has issued a notice in a petition by the Haemophilia Federation of India seeking inclusion of haemophilia under the Rights of Persons with Disabilities Act, 2016’s provision which mandates a 4% reservation in government employment for persons with benchmark disabilities (those with 40% or more disability). Further, if there cannot be an inclusion, the petitioners have prayed for striking down the exclusion.
Source: urli.info/1eoZ1

3. A report by CyberPeace warns that early exposure to online gaming is increasingly linked to obesity, sleep disruption, repetitive-strain injuries and mental-health issues among children. It urges India to adopt robust age-verification mechanisms, formal content ratings and a “living legislation” framework for game developers and publishers.
Source: urli.info/1eoZa

4. The Indian Pharmacopoeia has reportedly been officially recognised by 17 countries as the authoritative standards for medicines. This recognition will enhance the quality assurance of pharmaceutical products, eliminate duplicate testing, promote export growth, and strengthen India’s position as a reliable supplier of affordable, high-quality medicines worldwide.
Source: urli.info/1jcwP

5. Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on advertising therapeutic goods on social media, clarifying legal responsibilities for advertisers, influencers and account holders. The update outlines what qualifies as advertising, the use of testimonials, mandatory health warnings and common breaches, after removing over 13,700 unlawful ads in FY 2024 25.
Source 1: urli.info/1jcwR
Source 2: urli.info/1jcwU

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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.Kerala High Court has ordered against the usage of “Dr.” prefix by physiotherapists and occupational therapists who do not possess recognized medical qualification. The order came while considering challenges to recent curriculum provisions allowing such usage, the next hearing is scheduled on December 1, 2025.
Source: urli.info/1em0-

2.The National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling prices for six scheduled formulations, including riboflavin tablets, peritoneal dialysis solutions, ethyl alcohol, and human normal immunoglobulin. Manufacturers and importers are mandated to align MRPs to the notified prices, file Form V on IPDMS and ensure that retailers/distributors display price list in their premises.
Source: urli.info/1j9u0

3.The Delhi High Court has expressed concern over an advertisement by a leading ayurvedic drug company that labels rival company product as “dhoka” (fraud). The Court questioned whether the use of such terminology crosses the permissible threshold and amounts to impermissible disparagement of a competitor’s product.
Source: urli.info/1j8ZY

4.The Food Safety and Standards Authority of India (FSSAI) has notified the Food Safety and Standards (Import) First Amendment Regulations, 2025, effective May 1, 2026. The amendment allows FSSAI approved or globally recognized analytical methods and mandates that the notified or referral laboratory to submit duly signed food analysis reports within five days of receiving samples.
Source: urli.info/1j9up

5.The Ministry of Health and Family Welfare has issued a draft amendment to the Drugs Rules, 1945 to include cell or stem-cell derived products, gene therapeutic products and xenografts under the regulatory framework currently governing recombinant DNA derived drugs, aligning regulatory provisions and licensing forms with emerging Source:
advanced biological therapies.
Source: urli.info/1j9ta

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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 government’s ban on sending genetic samples outside the city for prenatal tests like NIPT and PGT, reportedly, faces strong opposition from diagnostic labs in Delhi. The labs have raised concerns that it will overload local labs, cause delays, increase costs, and limit access for patients in NCR and nearby states, urging reconsideration of the directive.
Source: short-url.org/1gmX1

2. The Bombay High Court has in a customs case held that allowing re-testing of seized goods is a trade facilitation measure. Denials must be rare and when made should be supported by written reasons. The court emphasized that refusal to retest should not be the norm.
Source: short-url.org/1gmXa

3. The Indian government will reportedly require all hospitals, both public and private, to include an Adverse Drug Reaction reporting form in every patient admission record. This under the Pharmacovigilance Programme of India aims to standardise monitoring of drug safety and better protect patients from adverse effects.
Source: short-url.org/1bHWo

4. The Committee for Control and Supervision of Experiments on Animals (CCSEA) has clarified that beagle dogs procured from breeders registered with State Animal Welfare Boards or State Animal Husbandry Departments are strictly for breeding colonies, not for experimentation. For testing, dogs must be sourced from CCSEA registered establishments.
Source: short-url.org/1bHWu

5. To ease certificate issuance delays, India’s central drug licensing authority reportedly has plans of shifting data verification in the CoPP (Certificate of Pharmaceutical Product) process to later stages instead of initial stage and conduct verification themselves bypassing initial scrutiny by state regulators.
Source: short-url.org/1gmXq

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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. Central Board of Indirect Taxes and Customs (CBIC) has issued Notification revising GST rates effective September 22, 2025, after the 56th GST Council meeting. The GST rates for medical devices, drugs, food, beverages, and cosmetics have been notified.
Source: short-url.org/1f8PY

2. India’s Central Drugs Standard Control Organization (CDSCO) and Indian Council of Medical Research (ICMR) have issued a unified national protocols for evaluating in-vitro diagnostic kits for Chikungunya, Dengue, Zika and others. These guidelines set strict criteria on sensitivity, specificity, and quality, ensuring accurate diagnostics and strengthening regulatory oversight to improve access to quality-assured diagnostic kits in India.
Source: short-url.org/1f8Q4

3. The National Medical Commission has advised medical colleges to strengthen rabies case management via regular training, surveillance, and community outreach. Colleges must guarantee continuous supply of anti-rabies vaccine (ARV) and anti-rabies serum (ARS), maintain a register of animal bite exposure cases, and report suspected rabies cases through state nodal officers via IHIP under IDSP.
Source: short-url.org/1f8Qh

4. The Directorate General of Health Services is set to introduce new regulations establishing minimum standards for medical sample collection and transportation. These standards aim to ensure that blood, urine, and swab samples are handled by trained professionals and transported under proper conditions, including maintaining a cold chain, to prevent contamination and ensure accurate test results.
Source: short-url.org/1f8Qw

5. The Drugs Control Administration (DCA), Telangana suspended licences of 165 medical shops and permanently cancelled seven for retailing MTP kits without valid prescriptions or licensed supervision. 800+ inspections revealed violations including OTC sales of abortifacient drugs (mifepristone, misoprostol), lack of required records, and dispensing without qualified pharmacists.
Source: short-url.org/1f8QF

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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

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 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 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