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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 central food authority (FSSAI) has extended the enforcement date for the amended labelling requirements under the Alcoholic Beverages Regulations, 2025. The earlier deadline of 1 January 2026 is now postponed to 1 July 2026. The decision follows stakeholder concerns that mid-year labelling changes would disrupt operations, cause wastage of pre-printed labels, and create additional costs, especially due to State Excise label-registration cycles.
Source: h7.cl/1kc0S

2. India is reportedly negotiating mutual recognition agreements (MRAs) with major partners such as the US, EU, UK, Singapore and ASEAN to align inspection and testing systems. The aim is to cut rejections, ease trade friction and streamline exports of basmati rice, spices, tea, coffee, marine products, fruits and vegetables, improving global competitiveness.
Source: h7.cl/1flqZ

3. India’s central food authority (FSSAI) has issued amendments to the FSS (Alcoholic Beverages) Regulations, 2018 wherein the permissible maximum level of ethyl acetate esters in alcoholic beverages has been increase from “0.2” g/l to “3.0” g/l.
Source: h7.cl/1kc16

4. India’s Drugs Consultative Committee has agreed to add levonorgestrel tablets in 0.75 mg and 1.5 mg widely known as morning-after pills to Schedule K, enabling continued OTC sales. This also includes provisions for a boxed warning on packaging highlighting side effects, no protection against HIV/STIs, limits on use, and recommendations for consulting practitioners on alternatives.
Source: h7.cl/1kbV8

5. The Supreme Court of India has reportedly directed Noida District Hospital to constitute a primary medical board within two weeks to assess passive euthanasia for a 31-year-old man who has been quadriplegic and in a vegetative state for more than a decade.
Source: h7.cl/1flra

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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. Government hospitals in Delhi will now use a different coloured bedsheet each day of the week (white, pink, green, purple, blue, light-grey, peach) under a new rotation system. The measure aims to enforce daily linen change, boost hygiene standards and reduce hospital-acquired infections.
Source: shorturl.at/kzVxx

2. The Department of Pharmaceuticals has invited applications under the Production Linked Incentive Scheme (PLI) for domestic manufacturing of Meropenem and Ritonavir. Eligible manufacturers can apply online from 27 November to 26 December 2025. The scheme specifies minimum annual production capacities and limits the number of applicants for each product.
Source: shorturl.at/DNuCk

3. The Kerala High Court has upheld the Kerala Clinical Establishments Act, requiring hospitals to display all service details and rates at reception areas and on their websites. Hospitals must also provide grievance-redressal information and cannot deny emergency care for lack of advance payment.
Source: shorturl.at/Cm1AZ

4. The Drugs Consultative Committee has urged nationwide uniformity in enforcing drug standards, highlighting delays, inadequate infrastructure, and low conviction rates. It recommended that the Union Government direct states to strengthen laboratories, manpower, and regulatory capacity under the State Health Regulatory Excellence Index to ensure consistent national drug quality.
Source: shorturl.at/ARjaQ

5. The Patents (Amendment) Rules, 2025 establish a fully digital system for investigating IP contraventions, issuing penalties, and processing appeals. New Forms 32 and 33 enable electronic filing of complaints and appeals, with strict timelines of 3 months for adjudication and 6 months for appeals, enhancing compliance certainty for industry innovators.
Source: h7.cl/1figr

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

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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

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 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

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 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

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 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

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 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