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 Delhi government’s ban on sending genetic samples outside the city for prenatal tests like NIPT and PGT, reportedly, faces strong opposition from diagnostic labs in Delhi. The labs have raised concerns that it will overload local labs, cause delays, increase costs, and limit access for patients in NCR and nearby states, urging reconsideration of the directive.
Source: short-url.org/1gmX1

2. The Bombay High Court has in a customs case held that allowing re-testing of seized goods is a trade facilitation measure. Denials must be rare and when made should be supported by written reasons. The court emphasized that refusal to retest should not be the norm.
Source: short-url.org/1gmXa

3. The Indian government will reportedly require all hospitals, both public and private, to include an Adverse Drug Reaction reporting form in every patient admission record. This under the Pharmacovigilance Programme of India aims to standardise monitoring of drug safety and better protect patients from adverse effects.
Source: short-url.org/1bHWo

4. The Committee for Control and Supervision of Experiments on Animals (CCSEA) has clarified that beagle dogs procured from breeders registered with State Animal Welfare Boards or State Animal Husbandry Departments are strictly for breeding colonies, not for experimentation. For testing, dogs must be sourced from CCSEA registered establishments.
Source: short-url.org/1bHWu

5. To ease certificate issuance delays, India’s central drug licensing authority reportedly has plans of shifting data verification in the CoPP (Certificate of Pharmaceutical Product) process to later stages instead of initial stage and conduct verification themselves bypassing initial scrutiny by state regulators.
Source: short-url.org/1gmXq

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