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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 directed the Food Safety and Standards Authority of India (FSSAI) to consider mandatory front-of-pack warning labels on packaged foods. This move aims to inform consumers about high levels of sugar, salt, and saturated fats, addressing rising health concerns like obesity and diabetes. The court emphasized prioritizing public health over industry resistance.
Source: h7.cl/1jEhc

2. The Indian government has tightened the IT intermediary law, by an amendment that defines synthetic media, and require social media platforms to remove flagged harmful content within three hours, enhancing accountability and curbing misuse of AI online. The amendment also obliges intermediaries offering AI tools to deploy technical (including automated) measures blocking unlawful deepfake and synthetic content.
Source: h7.cl/1jEgT

3. India’s Supreme Court has issued notices to the Central Government and National Medical Commission on a PIL seeking exemption of medical professionals from the Consumer Protection Act. The petition argues consumer law undermines doctor-patient trust and promotes defensive medicine. The Court’s decision remains pending.
Source: h7.cl/1jEhX

4. The Supreme Court reportedly directed the Gujarat Pollution Control Board to decide within a week on Pharma company’s plea to reopen its Dahej plant, producing hexafluoro-methoxypropane, a key sevoflurane intermediate. It was shut over alleged hazardous waste discharge into the Narmada River. The court denied interim relief, advising remedies via statutory authorities and the National Green Tribunal.
Source: h7.cl/1jEh-

5. United States Food and Drug Administration reportedly issued a warning that a major pharma company’s Television advertisement for its obesity pill is false or misleading as it suggested unproven superiority and benefits over other GLP one medicines. The regulator directed corrective action to ensure accuracy and protect patients.
Source: h7.cl/1oHAn

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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 constituted a committee to develop a policy governing refurbished medical devices. The committee will examine the scope of refurbished medical devices, methodology to evaluate the safety, performance, and remaining useful life of refurbished medical devices & suggest guidance for waste disposal of such refurbished devices.
Source: h7.cl/1o8qd

2. Indian government has announced a tax holiday until 2047 for foreign companies that provide cloud services globally using data centres located in India. Further, there will be no risk of foreign firms’ global income being taxed in India solely because they use Indian data centres. This move is aimed at attracting long-term investment into India’s digital infrastructure.
Source: h7.cl/1o8qp

3. Indian Government has released first national evidence-based lung cancer treatment and palliation guidelines. It offers 15 recommendations to standardise diagnosis, treatment and palliative care, improve early detection, reduce treatment disparities and ensure consistent, patient-centred care across the country.
Source: h7.cl/1o8qA

4. India’s Ministry of Consumer Affairs issued show-cause notices to major edible oil companies for violating the amended Vegetable Oils Products, Production and Availability (VOPPA) Order, 2025. Companies failed to submit monthly production data and register on official portals. Authorities have warned that continued non-compliance could lead to inspections and confiscation under the Essential Commodities Act, 1955.
Source: h7.cl/1o8qN

5. The United States Food and Drug Administration has launched the PreCheck pilot program to strengthen domestic pharmaceutical manufacturing. The initiative offers early regulatory engagement for new manufacturing facilities, improving predictability, streamlining facility assessments and accelerating readiness to supply medicines for the United States market.
Source: h7.cl/1o8qS

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 and Medical Device Regulator, The Central Drugs Standard Control Organisation (CDSCO), has issued a public notice that it will reject applications if the queries to the applications are not responded within 90 days from the date of receipt of the query on its official application portal called SUGAM portal. A time-bound reminder and rejection mechanism for timely disposal of the pending applications has been introduced. Applications pending for two years will now be rejected after 30 days notice if no response is submitted.
Source: h7.cl/1i6LX

2. India’s Ministry of Commerce and Industry has extended the deadline for importers and manufacturers to obtain BIS certification for aluminium utensils and food and beverage cans covered under the Quality Control Order, 2026. The revised timelines are issued in a phase wise manner based on industry category, beginning from 1 October 2026.
Source: h7.cl/1i6L0

3. Several drug companies are cautious about a new fast approval program under the United States Food and Drug Administration. They fear quicker reviews may weaken scientific scrutiny, increase legal risk, and invite court challenges, even as others support faster access to important medicines for patients nationwide safely.
Source: h7.cl/1i6Lg

4. The Maharashtra Public Health Department has launched dedicated menopause clinics in Pune to provide specialised care for women’s physical and mental health needs. Weekly OPDs will be held every Wednesday at government hospitals, offering medical management, counselling, and lifestyle guidance. The initiative aims to address menopause-related health issues across urban and rural areas.
Source: h7.cl/1n5Uw

5. India’s Ministry of Agriculture and Farmers Welfare has announced that the Seed Act, 2026, to introduces a nationwide seed traceability through QR codes, mandate seed company registration, and impose penalties up to ₹30 lakh for substandard seeds, and safeguards the traditional seed systems and strengths transparency.
Source: h7.cl/1i6Lp

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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. A multinational pharmaceutical company has approached the Delhi High Court to restrain the domestic pharma giant from launching its generic version of semaglutide, a widely prescribed drug for diabetes and weight loss. This is the second suit by the plaintiff innovator against local firms wanting to launch copies of the drug
Source: h7.cl/1g6X3

2. Department for Promotion of Industry and Internal Trade (DPIIT) has issued a draft framework mandating blanket licence for legally accessible content for AI-training, but deferring royalty payments until commercialisation. The plan sets up a centralised royalty-collection mechanism, replacing “zero-price licence” proposals.
Source: h7.cl/1g6X7

3. The Delhi High Court has temporarily barred a local supplier from using a mark found deceptively similar to a well-known ayurvedic brand, holding that the adoption appeared misleading and capable of confusing consumers. The Court restrained manufacture, sale, promotion, and any creation of third-party rights during the proceedings.
Source: h7.cl/1l00x

4. The Drug Consultative Committee has noted that some State Licensing Authorities (SLA) are issuing manufacturing licenses for new drugs without prior written approval from the Central Licensing Authority (CLA), as required under The New Drugs and Clinical Trials Rules, 2019. Members unanimously agreed that SLAs must obtain CLA approval before granting any such manufacturing permission.
Source: h7.cl/1g6Xk

5. The United States Food and Drug Administration has reportedly finalized guidance on promotional labeling and advertising for biologics and biosimilars, outlining standards to ensure accurate and non-misleading communications. The document clarifies expectations for data presentation, comparative claims, and identification of products, with specific caution against comparisons that imply reduced safety or effectiveness.
Source: h7.cl/1l00M

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 Council for Research in Ayurvedic Sciences has launched SIDDHI 2.0, a national industry research interface platform, to accelerate scientifically validated Ayurvedic product development. The initiative brings together regulators, researchers, and manufacturers to promote quality, safety, regulatory compliance and global competitiveness of Ayurvedic pharmaceuticals.
Source: h7.cl/1fbDr

2. The Telangana Drugs Control Administration (DCA) has issued a circular requiring all licensed retail and wholesale pharmacies across the state to prominently display a QR code and toll-free number to report adverse drug reactions (ADRs). This step enforces compliance with Central Drugs Standard Control Organisation (CDSCO) guidelines, strengthening pharmacovigilance under the national Pharmacovigilance Programme of India (PvPI).
Source: h7.cl/1k1Ny

3. Karnataka Pharma Retailers & Distributors Organization (KPRDO) has reportedly urged the government to halt ten-minute medicine delivery services, warning that treating prescription drugs as fast-moving consumer goods violates drug safety laws. They argue that medicines require prescription verification and pharmacist oversight, and that instant access to antibiotics and addictive drugs could lead to misuse, antimicrobial resistance, and public-health risks.
Source: h7.cl/1fbDv

4. Public commenters are calling on the US Food and Drug Administration (FDA) to loosen clinical trial requirements, particularly for rare diseases and drug development. Commenters are urging the FDA to allow more flexible trial designs and reduced burden to accelerate access to therapies, especially for rare or underserved conditions like disseminated coccidioidomycosis.
Source: h7.cl/1k1NB

5. A major US retail chain has recalled several bottles of saline nasal spray after US Food and Drug Administration (FDA) tests detected contamination with Pseudomonas lactis. The Class II recall covers two production lots with 2027 expiry dates. While the risk is considered medically reversible, regulators advise consumers to stop using the affected batches immediately.
Source: h7.cl/1k1NE

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 authority has released guidance to identify spurious drugs under the Drugs Rules, 1945. Earlier, the rules mandated QR codes on all APIs from January 2023 and barcodes or QR codes on the top 300 drug brands from August 2023. The authority has now issued a process flow to verify drug authenticity.
Source : https://short-url.org/1gVQq

2. India’s Central Drug Regulator has allowed manufacturers to apply for Certificate of Pharmaceutical Product/World Health Organization – Good Manufacturing Practices (COPP/WHO-GMP) certificates while product license applications are under review by the State Licensing Authority. Final COPP/WHO-GMP certificate will be issued after product approval.
Source: https://short-url.org/1gVUB

3. India’s central government has proposed the Assistive Technology (Standards and Accessibility) Rules, 2025, requiring all assistive devices to meet Bureau of Indian Standards quality standards. The draft ensures transparent procurement, financial aid, repair support, and a toll-free helpline, with an online Assistive Technology Portal for device certification, supply tracking, and grievance redressal.
Source: https://short-url.org/1ceKb

4. The Food Safety and Standards Authority of India has kept the spice enforcement drive (whole & powder) in abeyance until further orders. All state food safety commissioners and regional directors have been instructed not to initiate any action under the earlier directive until further instructions.
Source:
https://short-url.org/1ceKS
https://short-url.org/1gVSp

5. The US Food and Drug Administration (FDA) is seeking public input on evaluating AI-enabled medical devices, including generative AI tools. The aim is to enhance patient outcomes, public health, and accelerate medical innovation, while regulating these advanced technologies
Source: https://short-url.org/1ceLs

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. Medical device companies have raised concerns over Uniform Code for Marketing Practices for Medical Devices (UCMPMD) and have approached the Department of Pharmaceuticals, citing overreach and operational challenges, particularly in the context of a DGHS advisory that restricted medical representative’s interactions with HCPs in government hospitals.
Source: bit.ly/3InfXiu

2. India’s Central Drugs Standard Control Organisation (CDSCO) is working on making drugs/medicine packaging more readable. The move aims to improve visibility of key details like expiry dates and dosages, addressing concerns over hard-to-read glossy labels. Proposed measures include clearer print standards and digital aids such as voice-enabled QR codes and Braille cards to enhance accessibility and consumer safety.
Source: bit.ly/46oMIpA

3. India’s Drugs Consultative Committee (DCC) has agreed to amend the Drugs Rules, 1945, to include Good Distribution Practices (GDP) guidelines for pharmaceutical products as a separate schedule. The decision follows detailed deliberations and stakeholder consultations to align with revised WHO guidelines.
Source: bit.ly/4lxABuC

4. The U.S. FDA is reportedly planning to revise the labeling for all extended-release stimulants prescribed for attention-deficit hyperactivity disorder (ADHD), requiring inclusion of a “limitation of use” section with a statement on higher rates of adverse reactions in children younger than six years.
Source: bit.ly/4l2REoA

5. The European Commission has amended its regulation to allow electronic instructions for use (eIFUs) for all medical devices intended for professional use, not just high-risk ones. Paper instructions are still required if the device could also be used by patients. eIFUs must be linked in Eudamed (the European medical device database).
Source: bit.ly/4lcdMx1

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 Health Ministry has requested the Department of Animal Husbandry and Dairying (DAHD) to share data on veterinary antibiotic manufacturers involved in the manufacturing, distribution, and sale of veterinary antibiotics. Additionally, members will be nominated for Antimicrobial Use (AMU) data collection and coordination with the Joint Working Group.
Source: bit.ly/4l6iHPD

2. India is expanding the availability of the HPV vaccine through Jan Aushadhi Kendras to improve accessibility and affordability. In addition, 116 essential generic medicines have been added to the national list thereby enhancing preventive healthcare efforts and strengthening the pharmaceutical supply chain.
Source: bit.ly/3FyEAIj

3. An Ayurveda professor from Banaras Hindu University (BHU) has written to Prime Minister of India, seeking an exemption under the Minamata Convention, an international treaty banning mercury use, to allow the continued use of mercury in traditional Ayurvedic medicines as it is vital for preserving their potency.
Source: bit.ly/45j9M8J

4. The United States Food and Drug Administration (US FDA) has released draft Questions & Answers (Q&A) guidance detailing the process for transferring ownership of 510(k) premarket notifications. Stakeholders may submit comments until August 4. The guidance aims to help sponsors ensure a smooth and compliant ownership transition process.
Source: bit.ly/4kBADSd

5. The United States Food and Drug Administration (US FDA) issued draft guidance and a proposed order outlining documentation for minor dosage form changes in highly soluble, highly permeable OTC monograph drugs. A separate order requires certain OTC monograph drugs to be packaged in single- or unit-dose containers for regulatory compliance.
Source: bit.ly/4jHnntZ