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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 Pollution Control Board (CPCB) has notified the establishment of a National Control Room (NCR) to coordinate and monitor nationwide enforcement of the ban on identified single-use plastic items. The NCR will support clarity, compliance tracking, stakeholder guidance, state control room reporting, inspections and awareness campaigns.
Source: h7.cl/1lmmL

2. The National Medical Commission has directed medical colleges to establish committees to monitor prescription practices, emphasising clear and legible handwriting and the use of generic drug names. The directive aims to strengthen patient safety, promote rational prescribing, and integrate these practices into medical education nationwide.
Source: h7.cl/1lmm6

3. Food Safety and Standards Authority of India has reportedly directed all states and Union Territories to launch a nationwide enforcement drive against adulteration and misbranding of milk, paneer and khoya. The move follows repeated detections and aims to protect public health through strict inspections and penalties across country.
Source: h7.cl/1gsAC

4. More than 60% of registered small and medium pharmaceutical units in India reportedly risk shutting down by December 2025 due to non-compliance with revised GMP (Schedule M) quality standards. Industry stakeholders warn of potential medicine shortages, job losses, and export disruptions if compliance challenges are not addressed promptly.
Source: h7.cl/1gsAd

5. The EU’s Medical Device Coordination Group has issued new guidance clarifying criteria for qualifying breakthrough medical and IVD devices under MDR/IVDR. It defines key criteria such as significant clinical benefit, unmet medical need, and innovation level, aiming to harmonize interpretation across authorities and support early regulatory engagement without lowering safety or evidence requirements.
Source: h7.cl/1lmli

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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 Indian Government has issued the Medical Textiles (Quality Control) Second Amendment Order, 2025. As per this amendment, any manufacturer or importer certified by the Bureau, or those who have applied for certification, and who have declared their existing stock of products, manufactured or imported prior to the implementation date specified in the principal order dated 23rd October 2024, will be permitted to sell, offer for sale, or display such non-BIS-marked stock until 31st December 2025.
Source: short-link.me/19ypP
Source: short-link.me/19yp3
Source: short-link.me/19ypb

2. India’s Ministry of Environment, Forest and Climate Change has extended the deadline for filing annual returns by Producers, Importers, Brand Owners, and Plastic Waste Processors for Year 2024-25 till 30th September 2025.
Source: short-link.me/15cIv

3. The Indian government has implemented a Central Sector Scheme to promote awareness about Ayurveda, Yoga, Unani, Siddha, and Homoeopathy through fairs, media campaigns, research, and quality certification. Measures also include strengthening drug testing, safety monitoring, international collaborations, and regulatory compliance for traditional medicine systems.
Source: short-link.me/19yqL

4. The Ministry of AYUSH has implemented the Central Sector Scheme “AYURGYAN” to boost research, education, and innovation in traditional medicine. It supports capacity building, clinical research, and interdisciplinary studies, including Ayurveda biology. The scheme promotes evidence-based AYUSH practices through collaborations with academic institutions and national research councils.
Source: short-link.me/19yqQ

5. Food Safety and Standard Authority of India has recently issued an advisory directed all licensed food businesses to display the QR code or download link of the “Food Safety Connect” app at their premises. This enables consumers and regulators to verify license details and lodge complaints easily, promoting transparency, digital access, and improved compliance in the food safety ecosystem.
Source: short-link.me/19yqW

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 launched a new CT 04 application module on its SUGAM online portal, streamlining the issuance of import licences for cell & gene therapeutic products to simplify and accelerate regulatory compliance and imports.
Source: bit.ly/3TGuNmR

2. A Central Drugs Consultative Committee panel has noted consumer complaints over unreadable expiry dates, tiny fonts, glossy packaging, and generic-brand confusion on medicinal products. It recommends forming a DCGI-led sub committee including a packaging expert to overhaul labelling norms and evaluate regulatory requirements for packaging suppliers under Drugs Rules, 1945.
Source: bit.ly/3IpVF8h

3. Food Safety and Standards Authority of India (FSSAI) has recently directed licensing authorities to audit annual returns filed by food business operators on the FoSCoS platform. Authorities have been directed to flag inconsistencies, permit revisions via updated portal features, and enforce penalties for false declarations.
Source: bit.ly/4lpGH0p

4. The Central Board of Indirect Taxes and Customs has mandated that customs officers verify the registration of plastic raw material importers on the Centralized Extended Producer Responsibility (EPR) Portal before clearing consignments. This directive aligns with the Plastic Waste Management (Amendment) Rules, 2024.
Source: bit.ly/3TYREu9

5. The Government of India has reportedly planned to transfer the National Health Claims Exchange (Insurance claims platform) from the health ministry to the finance ministry under Insurance Regulatory and Development Authority’s oversight to combat inflated hospital bills for insured patients.
Source: bit.ly/40hID2M

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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 extends PLI scheme application deadline
The Government of India has extended the application deadline for the Production Linked Incentive (PLI) Scheme aimed at boosting domestic manufacturing of Critical Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs). Eligible entities can now apply until July 4, 2025.
Source: bit.ly/3SXjvKE

2. Draft of ghee fatty acid limits, new cheese powder standards, revised drinking water norms issued by India Food Ministry
India’s Ministry of Health and Family Welfare has released draft amendments to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Key changes include updated ghee fatty acid limits, new cheese powder standards, revised drinking water norms, and additive restrictions. Public comments are invited latest by 4th August, 2025.
Source: bit.ly/4k0CfDP

3. Kerala High Court Bans Single-Use Plastics in Tourist Areas and Public Events
The Kerala High Court has banned single-use plastics in ten major hilly tourist destinations and all public events across the state, effective October 2, 2025. The move aims to curb pollution, mandates water kiosks in tourist spots, and directs strict enforcement by multiple state authorities.
Source: bit.ly/3FY3dhK

4. Essential Drug Prices Surge by Up to 20% Amid Global Conflicts
Essential drug prices in India have increased by 10 – 20% as per a leading drug traders association. Geopolitical conflicts have reportedly disrupted supply chains, leading to shortage of key raw materials like aluminium foil, used in pharmaceutical packaging and has driven up production costs for medicines.
Source: bit.ly/43RDxMM

5. Bombay HC rules treaty can’t override customs law
India’s Bombay High Court has ruled that treaty provisions do not override national customs law unless formally incorporated, affirming the jurisdiction of Indian customs authorities that issued show cause notices for alleged misuse of import exemptions.
Source: bit.ly/4ljpx4t

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. USA has requested India to remove import duties and relax stringent price controls on medical devices and relax rules on data localization policy with an aim to boost trade between nations.
Source: bit.ly/45hYyBt

2. The Central Pollution Control Board has introduced a step-by-step complaint module for changing login credentials on the Plastic Packaging Extended Producer Responsibility portal, easing access for affected companies.
Source: bit.ly/4e1NJWh

3. India’s Health Ministry mandates purchase invoice billing or provision of CGHS supplied medicines for Central Government Health Scheme claims, squeezing private hospital margins and prompting sector backlash
Source: bit.ly/3HT7nI4

4. Indian pharma companies increasingly deploy blockchain and smart contracts to enhance serialisation, ensure Drug Supply Chain Security Act (DSCSA) compliance, curb counterfeit drugs, automate supplier processes and reinforce production quality and security.
Source: bit.ly/3SRv85J

5. The Ministry of Consumer Affairs has issued further FAQs to provide clarity on the implementation of the Legal Metrology (Packaged Commodities) Rules, 2022. Key clarifications include guidelines on the declaration of MRP, labelling requirements for weighing machine, declaration regarding Institutional sale etc.
Source: bit.ly/440O2w7

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 Environment, Forest, and Climate Change has released draft rules under the Environment Protection Act, 1986, proposing Extended Producer Responsibility (EPR) for managing post-consumer waste from paper, glass and metal packaging along with sanitary products. These Rules aim to promote recycling, reuse, and waste-to-energy initiatives. Producers, importers, and brand owners must register and meet EPR targets from April 2026.
Source: bit.ly/49w0GFK

2. India’s Central Pollution Control Board (CPCB) has regulated the micro and small importers, producers, sellers and manufacturers of plastic raw materials and have mandated their registration on the EPR Plastic Portal. Filing of annual returns and compliance with all other EPR obligations is also outlined in the guidance issued by CPCB.
Source: bit.ly/49CJo9Z

3. India’s Supreme Court has reiterated that Ayurvedic/AYUSH doctors cannot claim parity with allopathic doctors, citing differences in academic qualifications and the standards of their respective courses. The court dismissed a petition by AYUSH doctors in Kerala, referring to past judgments that clarified the distinction in responsibilities and remuneration between allopathic and AYUSH practitioners.
Source: bit.ly/4iqyYhN

4. India’s Delhi District Consumer Commission has fined a leading FMCG company with a fine of ₹15 lakh for misleading advertisements about its “Fair and Handsome” cream, which claimed to provide fairness within three weeks without proper evidence. The Commission found the claims deceptive and an unfair trade practice, ordering the company to withdraw all misleading ads and packaging.
Source: bit.ly/3OPcMjE

5. India’s Central Drugs Standard Control Organization (CDSCO) has issued a circular thereby directing all State and Union Territory Drugs Controllers to ensure the approval of drugs and medical devices for rare diseases within 90 days of receiving applications to expedite the regulatory process and support faster access to treatment for rare diseases.
Source: bit.ly/3VvSFLl

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 Pollution Control Board (CPCB) has issued a Show Cause Notice to Producers, Importers, and Brand Owners (PIBOs) of Plastic Packaging for non-compliance with the Plastic Waste Management Rules, 2016. PIBOs must file their Annual Report and pay Annual Processing Charges for the FY 2023-24 to fulfill their Extended Producer Responsibility (EPR) obligations by 30th November 2024 to avoid levying of environmental compensation under the Environmental (Protection) Act, 1986.
Source: bit.ly/3Zs0XWY

2. India’s Directorate General of Foreign Trade (DGFT) has amended ITC (HS) 2022, Schedule-I (Import Policy), to align the latest tariff schedules and the Finance Act 2024 (No. 2 of 2024). The changes include updates to ITC (HS) codes through additions, deletions, amendments, splits, and mergers, aimed at streamlining import regulations, clarifying compliance standards, and fostering ease of doing business in international trade.
Source: bit.ly/3ZrYaNm

3. India’s Allahabad High Court has ruled that under the Food Safety and Standards Act, 2006 (FSS Act 2006), an offence will be considered to have occurred when the food analyst’s report confirming the violation is received, rather than when the food sample was collected by the Food Safety Officer. The ruling clarifies the timeline for initiating legal action under the Act.
Source: bit.ly/3Vc5hqA

4. India’s Goods and Services Tax Network (GSTN) has issued an advisory informing taxpayers about the launch of a new e-Services app, replacing the old e-Invoice QR Code Verifier app. The new app offers features like scanning QR codes to verify B2B e-invoices, provides GSTIN search functionality and most up-to-date information regarding approved B2B e-Invoice.
Source: bit.ly/4i7crX3

5. The Health Sciences Authority (HSA) of Singapore has taken action to combat the illegal sale and distribution of health products by removing over 3,000 unauthorized health products listings from local e-commerce and social media platforms. In the course of this operation, the authority has issued 1,471 warnings to sellers in an effort to safeguard consumers from substandard or counterfeit products.
Source: bit.ly/4ic7gF8

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 apex food regulator, Food Safety Standard Authority of India (FSSAI), has launched an online portal “Food Import Rejection Alert (FIRA)” for alerts on food import rejections and to ensure traceability and transparency. Also, food consignments from Sri Lanka, Bangladesh, Japan, China & Turkey has been rejected as they fell short of the standards.
Source: bit.ly/49aLJIT

2. Delay in clearance of import consignments of essential components has reportedly resulted in the disruptions in the manufacture of medical devices in India.
Source: bit.ly/3OpyhHx

3. India’s National Standards Body, Bureau of Indian Standards (BIS) to reportedly prioritize development of standards for 214 critical medical devices post consultation with the Department of Pharmaceuticals (DoP). Standards set to be completed by December 2025.
Source: bit.ly/3B2ZtZJ

4. India’s Meghalaya High Court has called for ban on manufacture, marketing and use of plastic of less than 120 microns.
Source: bit.ly/3Z4VT9C

5. The US Food and Drug Administration (FDA) has announced a temporary enforcement policy to enable certain sterilization site changes for Class III medical devices that are sterilized using ethylene oxide (EtO). Affected medical device manufacturers requesting enforcement discretion must submit an “informal notification” along with certain information to FDA.
Source: bit.ly/3OpairY
Source: bit.ly/3Zpx6OT

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 Punjab and Haryana High Court has urged the Indian government to introduce a legislation to regulate the preservation and disposal of blood in the country. Currently, the sale and disposal of blood is governed by executive instructions issued as guidelines by Centre and State governments.
Source: bit.ly/3TSStVv

2. India’s Central Pollution Control Board has further extended the timeline for filing the Annual Returns for Plastic Packaging Waste for the FY 2023-2024 for Producers, Importers and Brand Owners with Extended Producers Responsibility Registration to 30th November 2024. Previously, this deadline had been extended from 30th June 2024 to 30th September 2024.
Source: bit.ly/3JqZRBH

3. India’s Central Drugs Control Authority may reportedly direct drug regulators across all States and Union Territories (UTs) for uniform implementation of norms for new drugs, specifically regarding the approval of gastro-resistant and delayed-release dosage forms under the New Drugs and Clinical Trial (NDCT) Rules, 2019. The 64th Drugs Consultative Committee (DCC) meeting highlighted inconsistencies in the approval process for these products, which are classified as “New Drugs.”
Source: bit.ly/3XPOtq4

4. India’s Allahabad High Court has directed the Uttar Pradesh government to issue a standard operating procedure (SOP) for Chief Medical Officers (CMOs) and doctors regarding the medical termination of pregnancy (MTP) for timely abortions and proper implementation of existing laws.
Source: bit.ly/47MSBvk

5. India’s National Organ & Tissue Transplant Organization (NOTTO) has released a Standard Operating Procedure (SOP) for Human Organ Transportation by various modes like air, ambulance/ other vehicle, Trains, etc. The SOP includes standardized packaging, mandatory labelling with detailed donor and recipient information, handling of organ box and requirement of a medical personnel to accompany the organs along with necessary documentation.
Source: bit.ly/3BovUBR