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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 Consumer Protection Authority (CCPA) has penalised an online pharmacy for automatically renewing customers’ three-month subscriptions without explicit consent and termed its as an unfair trade practice. CCPA has held that “auto-add” feature amounted to a dark-pattern by pre-selecting paid options.
Source: h7.cl/1jXQH

2. India’s food regulator has invited inputs from original equipment manufacturers (OEM) or suppliers on draft technical specifications for LC-HRMS, LC-IRMS and EA-IRMS systems by December 1, 2025. A physical presentation will be held on December 3 in New Delhi, with priority given to OEM submissions.
Source: h7.cl/1jXRD

3. The Department of Pharmaceuticals (DoP) has proposed to exempt an additional 84 patented, proprietary and upcoming drug formulations from the Global Tender Enquiry cap. Domestic manufacturers have been invited to submit objections to the proposed list by December 5, 2025.
Source: h7.cl/1jXRR

4. The government has made enzyme-linked immunosorbent assay based infectious disease screening compulsory in all licensed blood centres after HIV infections linked to contaminated transfusions in Jharkhand. It will also impose stricter inspections and enforce licensing rules to strengthen national blood-safety standards.
Source: h7.cl/1jXR8

5. Kerala’s government is preparing to launch “Genome City” in early 2026 at the Bio360 Life Sciences Park in Thonnakkal. The 60-acre facility will host pharmaceutical, biotech and medical device companies, alongside high-end research centres. The initiative will leverage excellent connectivity and aims to drive innovation, create thousands of jobs, and accelerate approvals via a single-window system.
Source: h7.cl/1f7O-

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 clarification stating that only Indian-issued manufacturing, import, and sale licenses from the Central or State Licensing Authorities as applicable are mandatory for all medical devices in India. Procurement agencies and hospitals must require these licenses in technical bids. Any foreign certifications may be added but cannot replace mandatory Indian approval.
Source: h7.cl/1jTDc

2. India’s pharmaceutical industry is reportedly upgrading quality systems, regulatory alignment and scientific rigour as the Central Drugs Standard Control Organization (CDSCO) as tightens requirements for bioavailability and bioequivalence of oral drugs. Post-approval changes now require stronger data, dissolution studies, and risk-based evaluation. The move aligns India with global regulatory expectations and aims to enhance drug reliability, consistency, and overall patient safety.
Source: h7.cl/1jTDs

3. MNC drugmakers are urging CDSCO to grant 10-year regulatory data exclusivity for novel drugs, arguing it will protect first-mover clinical trial data, boost innovation, and attract R&D investment. This follows CDSCO’s sought industry feedback on rules that require the first applicant to conduct clinical trials and bioequivalence studies, while the subsequent filers could skip the trials.
Source: h7.cl/1jTDC

4. Raids by the Kerala Drugs Control Department in Kozhikode, Thrissur and Thiruvananthapuram revealed that discount pharmacies are stocking a wide array of counterfeit and poor-quality medicines, facilitated by weak inspection and unregulated distribution networks. Stakeholders are now urging Central Drugs Standard Control Organization (CDSCO) intervention.
Source: h7.cl/1jTDY

5. The National Accreditation Board for Testing and Calibration Laboratories has issued a guidance document to strengthen quality at medical laboratory sample collection centres, outlining requirements, hygiene and transport protocols, temperature control measures, and strict oversight to ensure integrity and reliability of patient test results across all facilities.
Source: h7.cl/1jTEn

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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 CDSCO via a circular has directed all licensing authorities to ensure that retail and wholesale pharmacy stores prominently display the designated Pharmacovigilance Programme of India (PVPI) QR code and toll-free number. This initiative aims to facilitate easy and seamless reporting of adverse drug reactions (ADR) by the public, strengthening drug safety monitoring.
Source: h7.cl/1jLf0

2. FSSAI has issued an advisory for dairy units selling milk/milk products via vending machines and kiosks, directing them to maintain approved rapid-test kits on-site for detecting common adulterants. The machines must display usage instructions, enable consumer self-tests or staff-demonstrations, retain usage records, and ensure kit validity and proper storage.
Source: h7.cl/1jLfi

3. The Food Safety and Standards Authority of India (FSSAI) has reportedly directed immediate removal of fruit-based beverages, R-T-S drinks and energy drinks labelled with the term “ORS” from retail and e-commerce platforms, reaffirming that only formulations meeting WHO oral-rehydration-solution standards may use “ORS”.
Source: h7.cl/1jLft

4. Indian Government reportedly plans to amend the Drugs and Cosmetics Act by adding sale licensing conditions a per which advertising of high-risk drugs in Schedules G, H, H1 and X will be explicitly banned, including via e-commerce and digital platforms, in order to curb self-medication, misleading claims an misuse of potent medicines.
Source: h7.cl/1jLfQ

5. Indian Government is reportedly framing a broader medical-device manufacturing policy aimed at cutting the country’s heavy import dependence. The plan focuses on boosting domestic production, introducing quality standards for thousands of devices, promoting zero-defect manufacturing, and strengthening India’s global competitiveness in the healthcare technology sector.
Source: h7.cl/1eWCg

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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 Indian government has withdrawn Quality Control Orders (QCOs) for critical materials like polypropylene and polycarbonate following an industry / NITI Aayog review, easing sourcing complexity for domestic medical-device manufacturers.
Source: h7.cl/1jJYy

2. The Supreme Court has requested the Centre and states to create a unified national policy under the Transplantation of Human Organs Act, citing stark inconsistencies across states in donor criteria, allocation norms and regulation. It also called for donor-welfare guidelines, uniform registry formats, brain-death reporting and swift establishment of organ-tissue organisations in lagging regions.
Source: h7.cl/1eVn7

3. India’s Union Commerce Ministry has sought detailed industry inputs on market access barriers for pharmaceutical exports to Russia, focusing on registration, market entry, price rules, and clinical trials, as it prepares submissions for upcoming talks in Moscow to strengthen India’s expanding pharmaceutical presence across Russia and the wider Eurasian region.
Source: h7.cl/1eVnb

4. The Indian government is reportedly considering tighter regulation of health insurance to curb soaring premiums, driven by rising medical costs and uneven claim payouts. Proposed measures include capping premiums, limiting agent commissions, and requiring stricter disclosure norms. Discussions are ongoing with the IRDAI, insurers, and hospitals to evaluate the measures.
Source: h7.cl/1eVnf

5. India’s leading food delivery platform is reportedly close to an agreement with restaurant associations to share customer contact details and ordering insights, subject to user consent. The move aims to resolve long-standing disputes over data access and could set a new industrywide model for platform restaurant data sharing.
Source: h7.cl/1jJZC

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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 Supreme Court of India has urged the Union Government to consider giving legal backing to the Uniform Code of Pharmaceutical Marketing Practices, 2024, noting that the current voluntary framework lacks effective enforcement and leaves patient unprotected. The Court indicated it may issue interim guidelines and sought detailed proposals for a statutory, government-enforced framework.
Source: h7.cl/1jDIt

2. The Competition Commission of India (CCI) has approached the NCLAT to clarify whether privacy safeguards for non-advertising data sharing should also apply when a social media platform shares user data with its parent company for advertising purposes. This follows the lifting of a five-year ban on such data sharing,
Source: h7.cl/1ePhT

3. India’s central drug regulator (CDSCO) reportedly plans for a digital tracking system for high-risk solvents like diethylene glycol and batch-level reporting to prevent cough-syrup contamination. Authorities are also increasing scrutiny of unlicensed rural pharmacies and considering removal of the Schedule K exemption that currently eases regulatory requirements for selling cough syrups.
Source: h7.cl/1ePhW

4. The Directorate General of Foreign Trade (DGFT) has resolved a long-standing issue affecting pharmaceutical exporters by clarifying redemption of Advance Authorisations (AAs) impacted by the old CGST Rule 96(10). The move addresses compliance hurdles for duty-free raw material imports for the pharma sector.
Source: h7.cl/1jDHw

5. Indian government has launched the National Action Plan on Antimicrobial Resistance (NAP-AMR) 2.0 (2025–29) to counter rising drug resistance. The plan sets clear timelines, strengthens surveillance, curbs antibiotic misuse, boosts lab and infection-control capacity, and adopts a One Health approach through coordinated, multi-ministerial action against the growing AMR threat.
Source: h7.cl/1jDHD

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 Pollution Control Board (CPCB) has issued a notice to producers, importers, and brand-owners (PIBOs) who have not filed their plastic packaging Extended Producer Responsibility (EPR) annual returns (AR) for FY 2024-25. The AR filing deadline was extended to November 30, 2025, and CPCB has warned that environmental compensation will be levied on non-complying entities.
Source: minilink.pro/1jAk4

2. The Indian government is reportedly set to impose a minimum import price (MIP) on about 10 critical pharmaceutical raw materials, targeting underpriced Chinese imports. The move aims to protect domestic API producers amid concerns over dumping and strategic dependence on China.
Source: minilink.pro/1jAki

3. A Munich court has reportedly held that an AI system unlawfully reproduced copyrighted lyrics from multiple songs, ruling that the model had memorized protected content during training. The court rejected arguments based on data-mining exemptions and user liability. This ruling sets an important precedent for copyright protection in AI-driven economy.
Source: minilink.pro/1jAkl

4. West Bengal has flagged off 110 self-sufficient Mobile Medical Units (MMUs), each equipped for 35 free clinical tests including blood tests and X-rays with doctors, nurses, and technicians onboard. The initiative, partly funded via MPLAD, targets healthcare delivery in remote, hilly, and tribal regions.
Source: minilink.pro/1jAkZ

5. Chief Executive Officer of Food Safety and Standards Authority of India has directed all the States/Union Territories to fast-track food-safety grievance redressal with fortnightly reviews and publish enforcement actions daily. He also directed mandatory NABL accreditation and optimal use of High-End Equipment in labs, emphasizing data-driven decisions, streamlined licensing, and stronger centralized surveillance for nationwide food-safety reliability.
Source: minilink.pro/1jAkx

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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 Ministry of Electronics and Information Technology has notified phased enforcement of the Digital Personal Data Protection Act 2023. Implementation will follow a phased timeline of 12-18 months, introducing consent-based processing, mandatory breach reporting, children’s safeguards, expanded data rights, and a digital-only Data Protection Board, marking the structured rollout of India’s data protection framework.
Source: minilink.pro/1jA7S

2. India’s Ministry of Electronics and Information Technology (MeitY) has recently notified the Digital Personal Data Protection Rules, 2025. The rules mandate clear consent, breach reporting, children’s data safeguards, and a digital-only Data Protection Board. Compliance is phased over 18 months, along with penalties for violations.
Source: minilink.pro/1eLQj

3. The National Pharmaceutical Pricing Authority has extended the existing ceiling prices for orthopaedic knee implants by one more year until November 15, 2026. Manufacturers and importers of orthopaedic knee implants will have to maintain the existing prices till November 15, 2025.
Source: minilink.pro/1jA8h

4. The Food Safety and Standards Authority of India has integrated its Food Import Clearance System with the Central Board of Indirect Taxes and Customs under the SWIFT 2.0 platform. This integration enables faster, more transparent, and technology-driven food import clearance, reducing delays, improving efficiency, and supporting India’s broader trade facilitation objectives.
Source: minilink.pro/1jA97

5. The Union Cabinet has approved the Credit Guarantee Scheme for Exporters (CGSE), offering up to INR 20,000 crore in collateral-free credit with 100 % guarantee via National Credit Guarantee Trustee Company (NCGTC). Including both MSME and non-MSME exporters, the scheme aims to boost liquidity, aid market diversification, and enhance global competitiveness of Indian exports.
Source: minilink.pro/1eLQH

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. 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

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 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