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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 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

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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 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 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.  A State Consumer Disputes Redressal Commission (SCDRC), Punjab has exonerated a private eye hospital from medical negligence allegations, finding no evidence that surgery was performed on the patient. The commission ruled that the claims were unfounded, thus dismissing the case against the hospital with no liability for damages.
Source: bit.ly/499Wxr0

2. The Delhi High Court has requested that the government create clear guidelines regarding doctors’ digital signatures on medical documents in order to reduce the use of unauthorized and fraudulent signatures in medical practices and to make clear the legal and regulatory implications of using digital signatures in healthcare.
Source: bit.ly/3YWXD4A

3. India’s Finance Minister, Nirmala Sitharaman has proposed to establish the creation of Bharat Food and Drug Administration (BFDA) to set global benchmarks for food and drug safety, similar to the US FDA. The emphasis to create such standard is to enhance India’s regulatory framework and strengthen its position in the global market.
Source: bit.ly/3V9E7Rb

4. The Indian government plans to amend the Drugs and Cosmetics Rules, 1945 to allow State Licensing Authorities (SLAs) and the Central Licensing Authority (CLA) to issue manufacturing licenses for products derived from stem cells and gene therapies. This move aims to streamline the regulatory process and promote the development of innovative therapies in India, enhancing compliance with global standards.
Source: bit.ly/3Os1VMx

5. The USFDA has finalized guidance for its 510(k) Third Party Review Program, which permits accredited third-party organizations to evaluate specific low- to moderate-risk medical devices for market clearance. The guidance is designed to expedite the review process to enhance efficiency in device approvals, ultimately facilitating quicker access to innovative medical technologies for patients.
Source: bit.ly/414wwHC

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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 Pollution Control Board has further extended the timelines for the filing of Quarterly Returns and Annual Returns of E-waste under E-waste Management Rules, 2022 for all registered entities on the online EPR portal till 31st December 2024.
Source: bit.ly/4eMsXZA

2. India’s Ministry of Health and Family Welfare (MoH&FW) is considering a proposal to amend the Medical Device Rules (MDR), 2017, to introduce specific timelines for various regulatory processes. These include conducting inspections, addressing non-conformities identified during inspections, and granting manufacturing licenses for medical devices across four classes (A, B, C, and D). The proposed changes aim to streamline approvals, enhance transparency, and improve regulatory efficiency in medical device manufacturing.
Source: bit.ly/4eH8aGL

3. The Indian Council of Medical Research (ICMR) has invited proposals for clinical studies on innovative medical devices and diagnostics under its Centre for Advanced Research (CAR) scheme. Offering up to ₹15 crore per project over five years, the scheme aims to validate and promote safe, effective, and regulatory-compliant healthcare technologies in India.
Source: bit.ly/4eH70vc

4. India’s Supreme Court has suggested the Central Government to formulate a policy on the construction of exclusive feeding rooms and childcare rooms in public places. Currently, there is no concrete law or policy on the feeding rooms and childcare rooms in public places.
Source: bit.ly/3ZiaQX1

5. The U.S. Food and Drug Administration (FDA) has released a guidance document titled Chemical Analysis for Biocompatibility Assessment of Medical Devices. This document outlines chemical characterization methods that can be used as alternatives to certain biological tests to demonstrate the biocompatibility of medical devices. It aims to enhance the consistency and reliability of analytical chemistry studies conducted as part of the biocompatibility assessment process for these devices.
Source: bit.ly/3OkJtFu

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 Supreme Court’s National Task Force (NTF), panel of eminent doctors constituted to make an action plan for ensuring the safety of healthcare workers, has opined that there is no requirement for enacting a separate central legislation to protect the doctors as there are already enough legal provisions to ensure their safety.
Source: bit.ly/4fVmIDK

2. India’s Directorate General of Foreign Trade (DGFT) has issued a trade notice to harmonize and streamline pharma export process and bring in line Schedule-II (Export Policy) with the latest tariff codes under the Finance Act, 2024. A draft of Schedule-II covering Chapters 01-98 of the ITC (HS) codes is open for public feedback and comments till 27th November 2024.
Source: bit.ly/3Zo7SR3

3. India’s Ministry of Environment, Forest, and Climate Change has informed that all registered Producers, Importers, and Brand Owners (PIBOs) under the Extended Producer Responsibility (EPR) regime of Plastic Packaging registered during FY 2022-24 are required to file their Annual Returns (AR) for FY 2023-24 by 30th November 2024. Failure to do so will result in their AR being auto-filed and levy of penalty i.e., EPR targets for FY 2024-25 will be increased by 25% over and above the EPR target for FY 2023-24.
Source: bit.ly/3JqZRBH

4. To safeguard patient data and mitigate cybersecurity risks posed by vendor networks, Indian hospitals are reportedly advancing in cybersecurity practices. 89% of hospitals have implemented third-party risk management systems however only 10% hospitals have adopted holistic data privacy programs, underscoring area for improvement. Hospitals are reportedly recommended to allocate 12-15% of their budget over the next two years to cybersecurity and digital infrastructure to remain resilient against cyber threats.
Source: bit.ly/3Oj1ggl

5. The United States Drug Enforcement Administration (DEA) has reportedly extended pre-pandemic telehealth regulations for prescribing controlled substances till 31st December, 2025. This decision allows telemedicine providers to continue prescribing controlled medications without requiring in-person visits, while the agency evaluates public feedback on proposed permanent regulations.
Source: bit.ly/3YTYUcK

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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. An interministerial committee constituted by the Department of Pharmaceuticals has proposed that health-supplements and nutraceuticals should be regulated as “Drugs” to ensure better quality control and to streamline insurance regulation as well.
Source: bit.ly/40QCmfk

2. In its recent meeting, the Ayurveda Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) has proposed to amend the Drugs Rules and regulate the retail sale of AYUSH medicine, which would empower drug inspectors to inspect these premises and collect and examine samples.
Source: bit.ly/3Cve0xR

3. The CDSCO is set to hold a round-table meeting for all Cosmetics industry stakeholders, including manufacturers and marketers to discuss issues including expansion of permission for cosmetics manufacturers to manufacture topical products.
Source: bit.ly/4ey6nDX

4. The Supreme Court dismissed a Special Leave Petition filed in response to the decision of the Delhi High Court seeking Order to mandate Doctors to explain side-effects to patients, holding that since there is no obvious issue highlighted with the side-effect information legally required to be presented by manufacturers, it is not necessary to require Doctors to do the same.
Source: bit.ly/48WLP70
Source: bit.ly/3UV5MoM

5. In a recent decision, the Supreme Court held that when examining petitions concerning procedural irregularities under the Arbitration and Conciliation Act, 1996, Courts should limit their examination to merely determining whether a valid arbitration agreement is existing and whether there is a preliminary dispute regarding appointment of Arbitrators.
Source: bit.ly/4ezdTP6

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, Forests, and Climate Change has notified the E-Waste (Management) Second Amendment Rules, 2024. The amended rules outline actions to be taken in the event of any non-compliance and violation of the E-Waste (Management) Rules, 2022. Previously, the rules specified prosecution for certain violations such as providing false information, using forged certificates, willfully disregarding directions, or failing to cooperate in verification and audit proceedings along with the imposition of environmental compensation.
Source: bit.ly/4fR1F5c

2. India’s Food Safety and Standards Authority of India (FSSAI) has instructed e-commerce Food Business Operators (FBOs) to ensure that food products have a minimum shelf life of 30% or at least 45 days remaining until expiration at the time of delivery to the consumer. The authority also issued a warning against unsupported online claims and reiterated that no FBO can operate on e-commerce platforms without a valid FSSAI license or registration, underscoring the need for regulatory compliance.
Source: bit.ly/3Z9lzmA

3. India’s Ministry of Environment, Forests and Climate Change has notified the Air (Prevention and Control of Pollution) (Manner of Holding Inquiry and Imposition of Penalty) Rules, 2024. The rules establish the process for holding inquiries, including procedures for issuing notices, determining penalties, and addressing complaints regarding any act in contravention of the Air (Prevention and Control of Pollution) Act, 1981
Source: bit.ly/40Pwt21

4. India’s top consumer forum, the National Consumer Disputes Redressal Commission (NCDRC), has awarded a compensation of Rs. 25,000 in a medical negligence case in which the doctor issued an incorrect scan report, demonstrated deficiency in diagnosing the patient’s illness, and provided erroneous test results.
Source: bit.ly/4fSYUAF

5. India’s Karnataka High Court has ruled that the Appellate Authority has the implied power to issue an interim stay on the Internal Committee’s report under the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act 2013 (POSH Act). The court observed that the Act does not explicitly prohibit the appellate authority from passing such an order. Since the authority can set aside the impugned proceedings, it also has the implied power to grant an interim stay.
Source: bit.ly/4fLZn7u

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 government has expanded the definition of Homeopathic medicine, to include all drugs except those drugs “which is administered by injectable route”.
Source: bit.ly/48C6E7n

2. The government has given more powers to Adjudicating Officers under the food laws. In addition to existing power, they have now been granted the additional power to investigate cases of supply of false information as well as unlicensed operation of food business.
Source: bit.ly/3NPfCVw

3. India’s drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has issued a price-control notification requiring a proportional reduction in price of the drugs resulting from the reduction in the Customs Duty and GST.
Source: bit.ly/3YPz7Du

4. The Indian Medical Association has taken objection to the proposal of the Central Government to introducing category of “Geriatric Nursing Practitioners”, and the designation of these nurses as Medical Practitioners, stating that this conflicts with qualification requirements under the National Medical Council Guidelines.
Source: bit.ly/4fu2IrI

5. Several industry associations representing the Homeopathic industry in the United States, have filed a lawsuit challenging the power of the United States Food and Drug Administration’s (US FDA) power to require New-Drug Approvals, and further the USFDA power to prosecute and penalize violations.
Source: bit.ly/3YuZxJz

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 Supreme Court has ruled that a medical practitioner can only be held accountable for medical negligence if he lacks the necessary training or expertise or if he fails to use his reasonable skill in providing treatment, not because his treatment was unsuccessful.
Source: bit.ly/4e2eEzN

2. The Food and Drug Administration (FDA), Pune division has seized stock worth ₹1 crore due to misleading claims in two separate incidents. This includes ₹78 lakh worth of toothpaste with anti-inflammatory claims and ₹22 lakh worth of cosmetics with suspicious labels. In both cases, the FDA has alleged a violation of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and the samples have been sent for laboratory analysis.
Source: bit.ly/40hcyJa

3. India’s central drug regulator (CDSCO) has identified a list of 18 drugs declared as Not of Standard Quality (NSQ). The action has come after several states and union territories failed to report NSQ data, prompting the CDSCO to emphasize the need for timely submissions to enhance drug safety oversight.
Source: bit.ly/48njBSE

4. India’s central drug regulator (CDSCO) has identified four drug samples as spurious after drug inspectors in several states inspected them in September. Since the seized batch was not manufactured by the relevant pharmaceutical businesses, the manufacturer reported it as counterfeit. Drug samples are collected from sales and distribution locations as part of ongoing regulatory monitoring, and examined, and a list of spurious drugs is posted on the CDSCO portal once a month.
Source: bit.ly/3YqYqdE

5. To enhance guidelines and standards for the use of disinfectants and antiseptics in healthcare settings, the Indian Pharmacopoeia Commission (IPC) has released a draft of the new general chapter on disinfectants and antiseptics (Version 3.0) for public comments. The last date to submit comments is 8th December 2024.
Source: bit.ly/3YmXtmL