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 Karnataka High Court has ruled that cases involving offences related to the manufacture, sale, and distribution of drugs and cosmetics under Chapter IV can only be tried in a sessions court. The magistrate court must send the case to the Sessions Judge for trial. The court clarified that while no court lower than a Sessions Court can try these offences, it does not mean that the Sessions Court can take cognizance of the case directly without a committal order from the Magistrate’s Court.
Source: bit.ly/41uSVNZ

2. The Kerala High Court ruled that a married woman can undergo IVF with donor sperm even if her husband exceeds the age limit under the Assisted Reproductive Technology (Regulation) Act, 2021 as long as he provides consent. The Court laid down that the age criteria apply individually to men and women, ensuring fair access to ART services.
Source: bit.ly/4gTEffT

3. The Ministry of Textiles has released a comprehensive list of technical textile products included under the Production Linked Incentive (PLI) Scheme. This list encompasses medical and hygiene textiles like baby diapers, sanitary napkins, surgical dressings, and compression stockings. The scheme is designed to enhance India’s production capabilities in healthcare textiles, increase global competitiveness, and create job opportunities.
Source: bit.ly/3F5jW1w

4. The European Commission is seeking feedback from stakeholders on a proposal to extend the option of providing electronic instructions for use (eIFU) for all medical devices, not just high-risk products. The Commission’s proposal suggests that manufacturers of medical devices and their accessories be permitted to provide instructions in electronic form, rather than on paper, for professional users, in line with Regulation (EU) 2017/745. This move aims to reduce paper waste and improve accessibility for healthcare professionals.
Source: bit.ly/41hBFdz

5. Amid the looming threat of a 25% tariff on pharmaceutical imports, Indian drugmakers, are confident they can remain competitive in the US generics market. Major Indian drug manufacturers emphasized that shifting production to the US isn’t feasible, and Indian companies will continue offering cost-effective alternatives despite the tariff.
Source: bit.ly/41hqCRL

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.

Indian government intends to create a new AI law to protect news publishers’ rights
The Indian government plans to introduce a new artificial intelligence (AI) law that will safeguard the rights of news publishers and content creators while also minimizing harm to users. The new law will reportedly also have provisions for sharing the ‘proceeds’ among news publishers, content creators and AI-enabled technologies.
Source: bit.ly/4aF3DmM

Decrees from civil courts may be legally binding on criminal court in the matter of sentences and damages
The Supreme Court of India has held that while the outcome of civil law proceedings would not command the results of criminal law proceedings, they would have a significant influence on the latter while considering sentences or damages in such proceedings. However, such influence will operate only to the extent of holding the sentences or damages arising out of criminal proceedings as unsustainable in law.
Source: bit.ly/4aHiUmX

FDI inflow in pharma sector declines for FY 2023-24
The Foreign Direct Investment (FDI) equity inflow into the pharmaceutical sector has reportedly seen a decline of fifty percent (50%) in the first nine months of the Fiscal Year 2023-24 as compared to Fiscal Years 2022-23. The decline in FDI inflow during the FY 2023-24 comes after a significant growth of 45% reported for the 12 months ending in March, 2023.
Source: bit.ly/4aFlQ3F

DTAB plans to mandate free medicine from pharma companies as part of CSR
The Drugs Technical Advisory Board (DTAB) plans to amend the Drugs Rules, 1945 to include a requirement for pharmaceutical companies to donate at least one percent (1%) of their net profits to the distribution of free medications in medicine banks which will then be used by the Central and State governments at times of illness, calamity, or any other situation, as per necessity. A comparable amendment was proposed by DTAB in 2018 as well, however, it was only voluntarily implemented during that year. DTAB is a committee constituted by the Central Drugs Standard Control Organisation (CDSCO) entrusted to make policy decisions and send recommendations to the government of India in relation to technical aspects of the Drugs and Cosmetics Act and Rules. 
Source: bit.ly/3J4K8sb

Government introduces Ayushman Bharat Health Accounts to digitize health records
The Indian Government has introduced the Ayushman Bharat Health Account (ABHA) as part of its national healthcare scheme, aiming to digitize health records with unique account numbers and to enhance fund accessibility, medical transparency and easy upkeep of medical records. ABHA will be used by government hospitals, however, private hospitals will have the option to use ABHA for the creation and linking of health records making it non-binding at present.
Source: bit.ly/49nSHsM