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 (CPCB) has released guidelines for the establishment and operation of Common Bio-Medical Waste Treatment and Disposal Facilities (CBWTFs). These guidelines cover site selection, treatment technologies, infrastructure, record-keeping, and compliance monitoring to standardize practices across India.
Source: bit.ly/4jos50r

2. India’s Central Pollution Control Board (CPCB) has issued show cause notices to 11 Plastic Waste Processors (PWPs) for allegedly selling recycled plastic at unreasonably low prices. CPCB has ordered the cancellation of their registrations and imposed environmental compensation. The PWPs are required to respond or take appropriate action within 10 days from the date of issuance of the notice.
Source: bit.ly/42Jrbom

3. India’s Central Government has notified an amendment to the list of psychotropic substances under the Narcotic Drugs and Psychotropic Substances Act, 1985. Pursuant to this amendment, the following substances have been included in the list of psychotropic substances: 3-Chloromethcathinone (3-CMC), Dipentylone, 2-Fluorodeschloroketamine, and Bromazolam.
Source: bit.ly/4jFxhwM

4. A sunscreen brand has agreed to take down and modify its advertisement campaign disparaging a competitor brand by claiming that it is ineffective, causes skin pigmentation and makes misleading claims. The modification will include removing the term “online bestseller” and other references.
Source: bit.ly/4jmLrDm

5. The Food Safety and Standards Authority of India (FSSAI) has released a consultation on compliance with provisions of ‘Analogue in Dairy Context’ and is inviting public comments from the stakeholders. The authority aims clearly bifurcate ‘Dairy Analogues’ from regular dairy products. Stakeholders can send their suggestions by 15th June 2025.
Source: bit.ly/42w1ZBl

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