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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 Legal Metrology Division has clarified that the label declaration of “Manufactured by” is not required if the complete name and address of the brand owner is provided with the words “Marketed by” or “Brand Owner.” The declaration of manufacturer is a mandatory declaration under the Legal Metrology (Packaged Commodities) Rules, 2011.
Source: urli.info/1jgRA

2. The Department of Consumer Affairs, Legal Metrology Division, has clarified through the recently released Frequently Asked Questions that omission or obscuring of the maximum retail price is permissible on packages marked “Not for Retail Sale–For Institutional Customers Only” or “Evaluation Samples–Not for Sale”.
Source: urli.info/1jgRA

3. The Ministry of Agriculture and Farmers Welfare has issued draft Insecticides (Amendment) Rules, 2025, proposing to extend the compliance deadline for registration and related requirements under Insecticides Rules, 1971 from June 30, 2024 to June 30, 2026. Stakeholders may submit objections or suggestions within 30 days.
Source: urli.info/1jh3Q

4. The Gujarat High Court has held that healthcare services provided by private hospitals to in-patients are composite contracts, where the supply of medicines, implants, and consumables constitutes a “deemed sale” of goods embedded within the service, and hospitals are liable to pay VAT on the goods transferred during treatment as a works contract.
Source: urli.info/1eta4

5. India’s Delhi High Court directed Central Board of Indirect Taxes & Customs (CBIC) to frame a uniform policy on whether imports of products like “body massagers” or “sex toys” should be permitted or prohibited, noting inconsistent Customs practices. The Court said such decisions must follow national and contemporary standards, not the subjective discretion of individual officials.
Source: rb.gy/opp4oe

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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. The Food Safety and Standards Authority of India (FSSAI) has issued the Draft Food Safety and Standards (Alcoholic Beverages) Amendment Regulations, 2025, proposing tighter standards for special wine. The draft introduces a 0.3% sugar tolerance for “Brut” sparkling wine, removes “special wine used,” and makes standard-drink labelling mandatory. A format for public comments has been shared, and feedback is open until 3rd January 2026.
Source 1: urli.info/1jcbJ
Source 2: urli.info/1eoEY

2. The Central Drugs Standard Control Organisation (CDSCO) has reportedly instructed state drug controllers to immediately initiate inspections under the revised Schedule M for the manufacturing units that have not applied for extensions. For manufacturing units that have applied for extensions, the effective date for revised Schedule M implementation is January 1, 2026. The directive follows recent safety lapses, including the fatal cough-syrup incident.
Source: urli.info/1eoDR

3. The Goa Directorate of Food and Drugs Administration (DFDA) has directed all retail pharmacies to display QR codes to facilitate reporting of adverse drug reactions (ADRs) through the Indian Pharmacopoeia Commission’s ADR Monitoring System. QR codes must be prominently displayed to enable consumers and healthcare professionals to report ADRs.
Source: urli.info/1jcb0

4. The Indian Pharmacopoeia Commission, in partnership with NITI Aayog and the Central Tuberculosis Division, will reportedly develop new monographs for the anti-tuberculosis medicines delamanid, pretomanid and the rifapentine-isoniazid fixed-dose combination to enhance quality standards, support rational use and strengthen adverse-drug-reaction reporting.
Source: urli.info/1jcaF

5. The Food Safety and Standards Authority of India (FSSAI) has issued an advisory clarifying stating that honey samples exceeding the permissible 80 mg/kg limit for Hydroxymethylfurfural (HMF) shall be classified as “Substandard”, not “Unsafe.” The clarification follows the Scientific Panel’s view that current research is insufficient to determine health risks from higher HMF levels.
Source: urli.info/1eoD4

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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. India’s Health Ministry has amended the New Drugs and Clinical Trials Rules, 2019, permitting bioavailability or bioequivalence (BA/BE) studies in human subjects for export purposes for certain drugs approved in India or any one of the regulated markets (USA, EU, Japan, Australia, Canada, UK) through submission of an online application as notification and its acknowledgement by the Central Licensing Authority, subject to certain conditions. The conditions are mainly ethics committee approval, record-keeping, and minimum sample size.
Source: urli.info/1iRyM

2. India’s Health Ministry has issued the draft amendments to Schedule K of the Drugs Rules, 1945. Liquid antiseptics are now categorized separately for household and hospital use, with distinct labelling and licensing conditions to ensure proper manufacturing, packaging, and sale compliance by licensed manufacturers and wholesalers.
Source: urli.info/1e4F-

3. Indian Food Authority (FSSAI) has issued an advisory to all Designated Officers, Food Safety Officers, and Enforcement Teams to ensure proper disposal of seized, rejected, and expired food, including packaging, through approved methods like incineration, sanitary landfilling, or composting. Disposals must be supervised, video-recorded, and certified by authorised food safety officials.
Source: urli.info/1iRz4

4. Indian medical devices regulator (CDSCO) has issued an updated list of about 1,700 Indian Standards (IS) under the BIS Medical Equipment and Hospital Planning (MHD) division, covering around 20 categories including surgical, diagnostic, orthopaedic, dental, and hospital-planning equipment. All medical devices manufactured, imported, and marketed in India must mandatorily conform to BIS standards for regulatory and quality compliance.
Source: urli.info/1iRz9

5. India’s Health Ministry has proposed amending Schedule H2 of the Drugs Rules, 1945, which contains a category of medicines that are mandated to carry a barcode or QR code on their label, to expand it with a new “Table 2” listing key therapeutic categories vaccines, antimicrobials, narcotic and psychotropic drugs, and anticancer drugs. Stakeholders can submit comments within 30 days.
Source: urli.info/1iRzg

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TOP 5 HEALTH LAWS & POLICY UPADATES

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 Licensing authority has mandated to file all Post Approval Change (Form CT-06) applications for Cell and Gene Therapeutic Products exclusively through the SUGAM online portal after October 24 2025. Offline submissions will no longer be accepted thereafter.
Source: urli.info/1e0FX

2. The Indian Pharmacopoeia Commission has reportedly introduced 22 quality standards for blood and its components to ensure safe transfusions across India. These standards, to be included in the Indian Pharmacopoeia 2026, establish globally first comprehensive benchmarks ensuring quality, safety, and infection-free blood for patients nationwide.
Source: urli.info/1iNpx

3. The Ministry of Health and Family Welfare has issued draft amendments to the Drugs Rules, 1945, introducing provisions to debar applicants found submitting misleading, fake, or fabricated documents for licences or approvals. Offenders may face suspension for a defined period, with the right to appeal within 30 days. Stakeholder comments invited within 30 days of publication.
Source: urli.info/1e0Fx

4. The Delhi High Court held that a doctor accused of medical negligence can continue to earn a livelihood by working at other medical centres. The Court clarified that the restriction only bars the doctor from running their own centre and does not prevent them from practising their profession elsewhere.
Source: urli.info/1e0FN

5. A Consumer Dispute Redressal Forum in India has held that the absence of a pathologist’s physical signature on medical reports cannot alone justify the denial of an insurance claim. In a case where a policyholder’s claim was rejected due to a missing signature, the forum directed the insurer to reimburse the cost after finding no evidence of fraud.
Source: urli.info/1iNph

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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 Health Ministry has directed all manufacturers of high-risk pharma-grade solvents to obtain or register their licences on the ONDLS portal and upload batch-wise details, including quantity, CoA, and vendor information. A list of high-risk solvents has been issued, and State Drug Regulators have been directed to ensure that no batch is sold without compliance to these directions.
Source: urli.info/1iJjN

2. Central Drugs Standard Control Organization (CDSCO) has clarified that manufacturers of risk Class A and B medical devices not listed in its risk classification list must obtain proper risk classification from CDSCO before applying for a manufacturing licence. Investigational medical device manufacturers must also secure prior CDSCO permission before the grant of manufacturing licence.
Source: urli.info/1dXH7

3. India’s Central Drugs Standard Control Organization (CDSCO) has issued a list of Class A non-sterile and non-measuring (NSNM) medical devices which are exempted from licensing requirements. Manufacturers and importers of the listed devices must obtain CDSCO registration as Class A NSNM medical devices under the Medical Devices Rules, 2017.
Source: urli.info/1dXHz

4. The National Company Law Appellate Tribunal has ruled that the Competition Commission of India lacks jurisdiction to investigate alleged anti-competitive conduct involving patented pharmaceutical products, emphasising that the Patents Act, 1970 prevails over the Competition Act, 2002 when the conduct in question arises from the exercise of patent rights.
Source: urli.info/1dXHI

5. The Delhi High Court has upheld the FSSAI’s directive prohibiting companies from using the term “ORS” (Oral Rehydration Solution) on product labels unless the formulation meets prescribed standards. The Court held that public health considerations override commercial claims and that products misleadingly labelled as “ORS” could endanger consumers. While the company may request FSSAI permission to re-label existing stock, the ban itself remains in force.
Source: urli.info/1iJkL

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 Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document outlining regulatory pathways, quality standards, and risk management requirements for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). Stakeholders are requested to submit feedback within 30 days.
Source: h7.cl/1iyvi

2. India’s Ministry of Consumer Affairs has amended the Legal Metrology (Packaged Commodities) Rules, 2011, to exempt medical devices from the standard packaging declaration requirements. Packages containing medical devices will adhere to the Medical Devices Rules for height and width of numerals and letters used in declarations. This amendment will ensure regulatory consistency and eliminate duplication of compliance requirements.
Source: h7.cl/1iyuq

3. The Health Ministry has issued draft amendments to the Drugs Rules, 1945, proposing that oral formulations with over 12% v/v ethyl alcohol and packed in bottles over 30 ml will be excluded from Schedule K and included in Schedule H1 for prescription-only sale. Stakeholders are requested to submit comments within 30 days.
Source: h7.cl/1dNdh

4. The Ministry of Environment, Forest & Climate Change (MoEF&CC) has amended the list of “White Category” of industries, which are exempted from air pollution consent requirements. Now the list includes 86 non-polluting sectors, such as food packaging, small bakeries, etc. to simplify compliance, especially for MSMEs.
Source: h7.cl/1dNcN

5. The Food Safety and Standards Authority of India (FSSAI) has recently issued an order introducing a dedicated “seasonal food business” registration category in the FoSCoS portal. Effective from August 01, 2025, the provision allows retailers and food vending agencies at fairs and festivals to register for up to three months by paying a ₹100 fee.
Source: h7.cl/1dNdx

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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 Consumer Affairs has uploaded the list of revised retail sale prices declared by companies in response to the recent GST rate changes. This update reflects company’s adjustments to the new tax rates, impacting pricing across various product categories, including drugs and medical devices.
Source: https://short-url.org/1cK-p

2. Investigations into the cough syrup incident have reportedly revealed that the manufacturer allegedly paid a 10% commission to the doctor for prescribing the syrup. Authorities are continuing their probe, focusing on both the manufacturer and the doctor’s involvement in the case.
Source : https://short-url.org/1cK-H

3. The National Medical Commission is reportedly planning to prohibit pharma and medical device promotions during live surgery broadcasts, citing misuse for marketing over education. Live surgeries will be allowed only for new procedures, with recordings preferred for others, to prevent ethical breaches and ensure patient safety in medical demonstrations
Source: https://short-url.org/1cK-P

4. The Delhi High Court has permitted the launch of an affordable generic version of a drug used to treat spinal muscular atrophy, upholding that a credible challenge was raised to the patent and emphasising that affordable access to life-saving treatment outweighs the need for injunctive relief in public interest.
Source : https://short-url.org/1cL07

5. The US Food and Drug Administration (FDA) reviewed a direct-to-consumer TV advertisement by a major drug manufacturer and found it false and misleading. According to the FDA, the ad’s rapid visuals, background music, and frequent scene changes distracted viewers, hindering understanding of important risk information and creating a misleading perception of the drug’s effectiveness among consumers.
Source : https://short-url.org/1cL04