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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 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

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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 District Consumer Disputes Redressal Commission in Hyderabad has ordered a compensation of Rs. 10 lakh to a patient after cardiologists at a local hospital made the patient undergo multiple procedures in one go without understanding the need for multiple procedures, and failed to follow standard protocols during treatment. The commission determined that the doctor’s negligence led to significant complications, proving a deficiency of service which was against patient safety and care.
Source: bit.ly/3VufMps

2. The National Medical Commission (NMC) has released comprehensive guidelines to identify and prevent the admission of fake patients in medical colleges, a practice that undermines patient care and ethical standards. The guidelines highlight red flags such as unusually high admissions on inspection days, absence of significant medical conditions, and lack of necessary investigations. Institutions found engaging in this unethical practice may face stringent penalties, including hefty fines and restrictions on student admissions.
Source: bit.ly/4iDw5ua

3. India is set to introduce “nafithromycin”, the first indigenous macrolide antibiotic, pending final approval from the Central Drugs Standard Control Organization (CDSCO). This innovative antibiotic, which is ten times more effective than azithromycin, offers a rapid three-day treatment for community-acquired bacterial pneumonia caused by drug-resistant bacteria, marking a significant advancement in the fight against antimicrobial resistance (AMR).
Source: bit.ly/4f4vuP6

4. The Indian government is intensifying efforts to eliminate tuberculosis (TB) by 2025, targeting 347 high-focus districts across 33 states and Union territories. A 100-day TB elimination campaign will be launched by the Union Health ministry in this regard to enhance case detection, reduce diagnostic delays, and improve treatment outcomes, particularly among high-risk groups.
Source: bit.ly/49qNnXb

5. The USFDA is considering a ban on Red 3, a synthetic food dye linked to potential health risks, including cancer and behavioural issues in children. This decision follows increasing public pressure and legislative actions in several states, including California, which has already prohibited the dye in food products. The FDA aims to act on a petition to revoke Red 3’s authorization in the coming weeks, reflecting growing concerns over food safety standards in the U.S.
Source: bit.ly/3Vvxed0

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 (MoH&FW) has reconstituted the Central Expert Committee tasked with determining compensation for patients implanted with faulty Articular Surface Replacement (ASR) hip implants. These implants had caused widespread health issues in India, necessitating regulatory action to ensure fair redressal for affected patients.
Source: bit.ly/4gjSZok

2. The Delhi government has urged the Ministry of Health and Family Welfare (MoH&FW) to amend the Clinical Establishments (Registration and Regulation) Act, 2010 (2010 Act) to make it applicable in Delhi. Under the current framework, the Act cannot be operational due to the Delhi Nursing Home Registration Act, 1953, being listed in the saving clause. An amendment is required for Delhi to regulate pathology laboratories under the 2010 Act effectively.
Source: bit.ly/3OKo60y

3. The Delhi High Court has directed the central government to consider a plea by the Center for Ichthyosis Related Members Foundation to recognize Ichthyosis as a disability under the Rights of Persons with Disabilities (RPwD) Act, 2016. This rare genetic skin disorder, characterized by rough, scaly skin lacks a permanent cure and significantly impacts the mental and physical well-being of patients. This classification would help mitigate discrimination and enhance support mechanisms.
Source: bit.ly/3OIfIi0

4. The Ministry of Health and Family Welfare (MoH&FW) has urged states for making snakebite cases and deaths a notifiable disease under state public health laws. Mandatory reporting by government and private health facilities aims to enhance surveillance and address factors contributing to snakebite mortality. The initiative is part of the broader action plan targeting a reduction in snakebite-related deaths by 2030 under National Action Plan for Prevention and Control of Snakebite Envenoming (NAPSE).
Source: bit.ly/3OMt38U

5. The Bharatiya Vayuyan Vidheyak, 2024, a bill replacing the Aircraft Act of 1934, was passed in Parliament during the Winter Session. The legislation aims to streamline aviation manufacturing, maintenance, and regulatory processes, ensuring ease of doing business.
Source: bit.ly/3VpbeAJ

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 Pharmaceuticals Export Promotion Council of India (Pharmexcil) has invited its members to identify export challenges and propose strategies to enhance pharmaceutical exports. Members have been asked to report on specific tariff and non-tariff barriers affecting trade and suggest innovative solutions, which will be collected through a dedicated “Issues & Strategies” section on the Pharmexcil website. This initiative aims to address existing hurdles and foster collaboration for the growth of India’s pharmaceutical industry in global markets.
Source: bit.ly/4gi7n09

2. The Karnataka government has suspended the state drugs controller for not taking procedural actions against the pharma company which supplied the substandard lactate IV fluid which resulted in the death of women. The use of this faulty intravenous fluid is believed to have contributed to serious complications during surgeries at a district hospital.
Source: bit.ly/3VsRQCP

3. The Health Research Authority (HRA) has proposed to simplify the process of seeking and recording consent for low-risk clinical trials in the UK. While the method for discussing trials with potential participants remains unchanged, the new approach allows prescribers to document consent directly in a participant’s medical record instead of requiring a written consent form. This ensures that informed consent is still legally mandated, and participants can withdraw at any time, while aiming to reduce administrative burdens and enhance trial efficiency.
Source: bit.ly/3BgotNm

4. The Fertiliser Association of India (FAI) has emphasized for setting a pricing hierarchy for fertilisers based on their nutrient content and suggested that di-ammonium phosphate (DAP), priced at Rs 1,350 per 50-kg bag, should be the most expensive one due to its high nutrient value. This price is currently lower than that of muriate of potash and complex fertilisers, which raises concerns about nutrient balance in agriculture as farmers increasingly turn to alternatives with less phosphorus content.
Source: bit.ly/41iwV9i

5. The Union Ministry of Women and Child Development has launched the upgraded SHe-Box portal to streamline the reporting and monitoring of sexual harassment complaints in workplaces across India. This centralized platform allows women to file complaints easily and ensures timely processing by Internal and Local Committees in government and private sectors, promoting a safer work environment.
Source: bit.ly/49pCxk5

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 Food regulator, the Food Safety and Standards Authority of India (FSSAI) has issued a advisory to e-commerce Food Business Operators (FBOs) to ensure that: (1) Last-mile delivery systems are made more robust, and persons handling last-mile delivery are given suitable training to handle the food items, and (2) The e-commerce FBOs are compliant with the labelling requirements as specified in relevant regulations, keeping the listings on the website consistent with content of actual food label.
Source: bit.ly/4f0zEaA

2. India’s Ministry of Finance has published an Office Memorandum seeking public comment up to the 10th of December, on certain amendments to the prevailing insurance regulations in the country. These proposed amendments include among other things, permitting a 100% Foreign Direct Investment in the insurance sector through the automatic-route, and permitting insurers to undertake offer of more than one class of insurance.
Source: bit.ly/4ifYwxT

3. India’s Central Ministry of Consumer Affairs is reportedly developing an online portal to handle the licensing, verification and stamping of weighing and measurement instruments as well as to provide a source of information on verified trade instruments for consumers.
Source: bit.ly/41km5Q6

4. The High Court of the States of Punjab and Haryana held that outside of introduction of evidence to the effect, the mere failure of a medical surgery/ procedure would itself not be sufficient to establish medical negligence claims, especially if the patient had been appropriately sensitized of the risks involved.
Source: bit.ly/49nlkrJ

5. In its finalized version of the regulations regarding Pre-determined Change Control Plans, the US Food and Drug Administration has plainly classified Artificial Intelligence (AI) as a sub-set of Machine Learning softwares when it comes to regulation of Medical Devices, and further makes it mandatory that in making submissions the version of the device software need to be submitted with the FDA to ensure version control.
Source: bit.ly/4imQQu2

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 Delhi High Court has granted relief to Dr. Devi Prasad Shetty, a renowned cardiac surgeon and chairman of Narayana Hrudayalaya Ltd. The court has issued a temporary injunction to protect his personality rights, prohibiting the misuse or misappropriation of his name, likeness, photos, videos, or any other aspects of his persona without his consent. The injunction also restricts the unauthorized use of the Narayana trademark for commercial gains.
Source: bit.ly/3BbWZZ1

2. India’s State Blood Transfusion Council (SBTC) of Maharashtra has introduced strict guidelines for blood donation camps in the state, prohibiting organizers from offering extravagant gifts and other high-value items to donors.
Source: bit.ly/49kLTxy

3. The Indian Government has reportedly expanded free treatment benefits under Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) to include all senior citizens aged 70 years and above. Also, approximately 1,961 procedures across 27 medical specialties, including General Medicine, General Surgery, Orthopedics, Cardiology, Oncology, and more, can now be availed by different age groups.
Source: bit.ly/3ZAyaiS

4. At the start of the final 2024 pandemic agreement negotiations, experts have reportedly urged countries to finalize the agreement to tackle future pandemic threats. Negotiations are set to continue, with hopes of reaching an agreement before 20th January, 2025
Source: bit.ly/4f1ly99

5. India’s Supreme Court has directed Public Prosecutors and Legal Aid Lawyers to uphold procedural fairness and the fundamental rights of the accused in criminal trials, ensuring effective legal aid. It is the Public Prosecutor’s duty to inform the Court about the need for free legal aid, as they are responsible for ensuring that the trial is fair and lawful.
Source: bit.ly/4fSa0WM

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 dismissed a Public Interest Litigation (PIL) seeking quality regulation for “prasad” food items distributed at religious places, stating that the Food Safety and Standards Authority of India (FSSAI) already oversees food safety standards.
Source: bit.ly/4eYIJAX

2. The District Consumer Disputes Redressal Commission in Delhi has ordered a compensation of Rs. 48 lakhs against a hospital and its doctors for performing surgery without the necessary expertise and proper disease assessment. The commission found that the medical professionals manipulated records to obscure the actual causes of the complications, which constituted medical misconduct and negligence.
Source: bit.ly/4iiLHTM

3. The Ministry of Consumer Affairs, Food & Public Distribution has issued draft rules for clinical electrical thermometers, inviting feedback from stakeholders by December 30, 2024. The draft rules provides technical standards of clinical electrical thermometers to ensure the accurate measurement of body temperature is recorded in clinical settings.
Source: bit.ly/3CVrjYs

4. India’s food regulator, the Food Safety and Standards Authority of India (FSSAI) has designated packaged drinking water and mineral water as “High-Risk Food Categories” after the removal of mandatory Bureau of Indian Standards (BIS) certification for these products. This decision will now require the manufacturers to undergo annual risk-based inspections and third-party audits before obtaining licenses or registrations.
Source: bit.ly/4i8DO3b

5. The Ministry of Consumer Affairs has released draft rules for non-invasive automated sphygmomanometers, inviting comments from stakeholders by December 30, 2024. The draft rules aim to establish regulatory standards for the measurement of blood pressure using these devices. The scope of the draft includes specifications for the design, performance, and testing methods required to ensure accuracy and reliability in clinical settings.
Source: bit.ly/3OC0Ku6

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 Central pollution regulator has issued a Notification extending the deadline to 31st December 2024, for submitting quarterly filings for the FY 2023-24 for all entities registered under the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2022.
Source: bit.ly/49ahqlK

2. A District Consumer forum in the State of Maharashtra has held that the refusal of returns by a e-commerce service provider, under a blanket “no-returns” policy constituted a “unfair trade practice” and awarded compensation to consumer whose return of sub-standard product had been rejected.
Source: bit.ly/417xJxQ

3. In a recently published response to a query received by it under the Right to Information Act, 2005, the Delhi Medical Council clarified that, since only medical practitioners registered with the council and having recognized qualifications in Allopathic medicine are permitted to practice medicine in Delhi: Dentists, who are registered with the Dental Council are not licensed to perform aesthetic and cosmetic treatment which is not medically necessary.
Source: bit.ly/3ZbT0Ur

4. After considerable negotiation, India has signed the final act of the Riyadh Design Law Treaty which aims to establish protections for Industrial Design patents, the treaty specifies procedural guardrails which member states can adopt into their own local design patent protection regulations.
Source: bit.ly/3CXRxcH
Source: bit.ly/4f5AYJz

5. The United States Supreme Court has declined to hear petition by manufacturers of tobacco products, challenging the decision of the Federal Government of the United States to include graphic visual warnings on cigarette packets.
Source: bit.ly/415u1EU

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