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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 Drugs Regulator (CDSCO) has clarified that modified or sustained-release form of a drug including gastro-resistant tablets/capsules, delayed-release tablets/capsules, or novel drug delivery systems will be regulated as ‘new drug’. New drugs must undergo clinical trials for obtaining manufacturing license
Source: bit.ly/41znUZe

2. India’s Central Licensing Authority (CLA) has directed manufacturers of unapproved fixed dose combination drugs to apply for permission to conduct Phase IV study / active post marketing surveillance within three months
Failure may result in cancellation of manufacturing license.
Source: bit.ly/3Xmpjjr

3. India’s Central Food Regulator (FSSAI) has reminded all food businesses that any post approval change in license information such as name of nominee, product category, expansion has to be communicated before such change takes place. Failure may result in cancellation of license.
Source: bit.ly/41AjyRq

4. India’s product standard setting body (BIS) has amended the Baby Diapers Standard 17509:2021. The amendment clarifies that actual dimensions of the diapers can vary based on the manufacturer’s design choices, with the diaper’s design being subject to the agreement between the buyer and seller.
Source: bit.ly/41znT7C

5. Clinical trial sponsors can add clinical trial sites and change the principal investigator (PI) by applying on SUGAM Portal.
The application for change of PI is deemed approved on application, and for addition of site within 30 days of application.
Source: bit.ly/41wrvHo

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 Corporate Affairs (MCA) has set a Deal Value Threshold (DVT) of ₹2,000 crore for mergers and acquisitions under the Competition (Amendment) Act, 2023. Transactions wherein the target company having substantial business in India if exceeds the given threshold, will have to obtain prior approval from the Competition Commission of India (CCI).
Source: bit.ly/3MGohZM

2. Ayurvedic businesses seeking to advertise ayurvedic drugs in Kerala must reportedly must secure permission from Kerala Drugs Control Department before making misleading and exaggerated claims via advertising. Advertisements made without approval will face legal repercussions.
Source: bit.ly/3AYOsbu

3. India’s Central Pollution Control Board (CPCB) has issued Environmental Compensation (EC) guidelines to address non-compliance with Extended Producer Responsibility (EPR) registration requirements, non-fulfilment of EPR obligations, non-filing of annual returns, among other violations under the E-waste Management Rules, 2022. These guidelines also regulate the cost of EPR certificates for fulfilling EPR obligations.
Source: bit.ly/3B05aY8

4. India’s Goods and Services Tax (GST) Council has decided to reduce the tax rate on cancer drugs – Trastuzumab Deruxtecan, Osimertinib and Durvalumab to 5% from the previous tax rate of 12%. The Council is reportedly set to finalize reductions in tax rates for health and life insurance premiums in its next meeting in November 2024.
Source: bit.ly/3zd6NB2

5. Medical Colleges in India must reportedly meet the safety and security measures of women doctors, nurses and students to get recognition from the Medical Education Regulator, National Medical Commission.
Source: bit.ly/3XEGNrT