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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. The Government of India, reportedly plans to establish a distinct category for advanced coronary stents and increase its ceiling price. This change is intended to ensure that stent manufacturers launching next-generation devices in India are not affected by price control measures.
Source: bit.ly/4cOGnU4

2. India’s Department of Pharmaceuticals (DoP) is reportedly developing a ‘Disposal Policy’ for sound disposal of expired, leftover, substandard, spurious, and adulterated drugs from the sale premises and from the households to prevent environmental damage and curb antimicrobial resistance (AMR).
Source: bit.ly/47dCgQ2

3. The Karnataka High Court has directed the Drug Controller General of India to establish an efficient online system whereby the drug samples which are sent for test/analysis are expeditiously tested and analysed by the Government Analyst within 60 days and the reports sent by them are available online on a real-time basis.
Source: bit.ly/3Te2Umc

4. India’s Department of Telecommunications (DoT) has advised all unregistered Machine to Machine Service Providers (M2M SPs) and WPAN/WLAN Connectivity Providers for M2M services to register with the DoT by September 30, 2024, to prevent any disruption to their services. Failure to comply may result in the withdrawal of telecom resources from authorized telecom licensees.
Source: bit.ly/3Xeknft

5. The Indian Council of Medical Research (ICMR) is reportedly developing evidence-based guidelines for the empirical use of antibiotics to address antimicrobial resistance (AMR), which is a significant public health challenge in India
Source: bit.ly/4cROOhl

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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 Public Interest Petition has been filed in the Delhi High Court, highlighting the need to require the use of verifiable Digital Signature on medical records and prescriptions to prevent fraud, misuse and fabrication of patient data.
Source: bit.ly/46qn6GP

2. The Indian Council of Medical Research has recently published Volume IV of the Standard Treatment Workflows which introduces new treatment methods for 32 common health conditions.
Source: bit.ly/3WCUqXO

3. The Indian government is set to launch a universal platform to track vaccination, U-Win which is reportedly based on the erstwhile Co-Win platform which had been maintained to track COVID-19 vaccinations,
Source: bit.ly/3SMCnfN

4. The West Bengal Clinical Establishment Regulatory Commission, the State level regulator of hospitals, clinics and healthcare centres, is set to issue an advisory mandating hospitals to pro-actively update the kin of patients on continued developments in health conditions to improve quality of counselling.
Source: bit.ly/4djmOUo

5. The United States Food and Drug Administration has finalized guidelines on the manner of use of Real World Data from Electronic Health Records, for the purpose of selecting and analysis of study data, as well as specifying limitation on the kind of data that can be used for clinical studies and regulatory decision making.
Source: bit.ly/3YfnV3i