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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 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. 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

India’s Central Pollution Control Board has issued final warning to all Producers, Importers, Brand Owners and Plastic Waste Processors, to complete Extended Producer Responsibility (EPR) registration on dedicated EPR portal latest by June 30, 2024, or face punishment.
Source: bit.ly/4cgRsxK

India’s Health Ministry has published Guidelines for Ethical Use of Leftover De-identified/ Anonymous Samples for commercial purposes.
Source: bit.ly/3RIc0XE

The Committee on Energy and Commerce in Congress of the United States of America has sought reply from US Food and Drugs Administration (US FDA) about institutional weaknesses in US FDA’s foreign inspection program over variations in inspection outcomes from India and China.
Source: bit.ly/3RF3xEH

India’s Karnataka High Court has formed a sub-committee to draft rules for establishing Intellectual Property Division (IPD) in Karnataka High Court. IPD benches are established with specialised judges to cater to Intellectual Property Disputes.
Source: bit.ly/4bmOVR8

India’s Kerala High Court, in a recent case, has framed guidelines for prosecuting guardian of a minor, or the owner of a vehicle driven by a minor, for offences involving vehicle driven by the minor.
Source: bit.ly/3RHALDn

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.

Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCO
The Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has issued a circular, stating that starting on 1st April 2024 it will require and restrict all manufacturers of Medical Devices/ In-vitro Devices to make submission of Periodic Safety Update Reports, only on the online portal and that offline mode of submission of application will not be accepted going forward.
Source: bit.ly/3TEO74B

Absence of Regulation of Second-Hand Medical Devices being Imported into India flagged by Parliamentary Panel
The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in a recent report, has highlighted that currently India’s Central Medical Device Regulations (Medical Devices Rules, 2017) do not regulate second-hand medical devices. The Committee has recommended framing policy to ensure its quality and safety, as well as introducing possible restrictions on import of second-hand or refurbished Medical Devices into India.
Source: bit.ly/3VsdCaQ

Supreme Court Orders Director of Company as well as Endorser of offending Advertisement to be present for Contempt Proceedings relating to misleading advertisements
As part of the ongoing action being taken against a major Indian Ayurvedic Medicine manufacturer for publication of misleading advertisements regarding its products in contravention of an undertaking provided to the Court, the Supreme Court, in pursuance of determining whether to pursue contempt proceedings against the manufacturer, has issued an order requiring the physical presence of the Director of the entity as well as a prominent Ayurvedic Yoga practitioner who had given his endorsement to the claims made in the offending advertisements of the Company.
Source: bit.ly/3vu45VQ

Delhi High Court orders suspension of accounts accused of impersonation of prominent investment group despite objection that no evidence of involvement is provided.
In pursuance of ongoing action against certain anonymous persons impersonating a prominent Investment group and misleading the general public, the Delhi High Court has issued a further order to messaging platform WhatsApp to take action to remove/ block access to certain accounts/ messaging groups, despite objection from the platform that the account/ messaging groups have been prove to neither violate T&Cs of WhatsApp, nor having carried out any illegal activity.
Source: bit.ly/3vkn7hu

EU Parliamentary Committee votes to present amendment to increase exclusivity period for orphan drugs and introduce extended regulatory data-protection period.
The European Parliamentary Committee on Environment, Public Health and Food Safety has voted in favour of introducing several amendments to the current EU Pharmaceutical Directive, including a controversial proposal to increase the exclusivity period for Orphan Drugs from 10 to 11 years, as well as an extended regulatory data-protection period of 9 years; both decisions that industry experts believe may have adverse consequences for competition in the EU Pharmaceutical Market.
Source: bit.ly/3Vr9zeK