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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 Health Ministry has amended the New Drugs and Clinical Trials Rules, 2019, permitting bioavailability or bioequivalence (BA/BE) studies in human subjects for export purposes for certain drugs approved in India or any one of the regulated markets (USA, EU, Japan, Australia, Canada, UK) through submission of an online application as notification and its acknowledgement by the Central Licensing Authority, subject to certain conditions. The conditions are mainly ethics committee approval, record-keeping, and minimum sample size.
Source: urli.info/1iRyM

2. India’s Health Ministry has issued the draft amendments to Schedule K of the Drugs Rules, 1945. Liquid antiseptics are now categorized separately for household and hospital use, with distinct labelling and licensing conditions to ensure proper manufacturing, packaging, and sale compliance by licensed manufacturers and wholesalers.
Source: urli.info/1e4F-

3. Indian Food Authority (FSSAI) has issued an advisory to all Designated Officers, Food Safety Officers, and Enforcement Teams to ensure proper disposal of seized, rejected, and expired food, including packaging, through approved methods like incineration, sanitary landfilling, or composting. Disposals must be supervised, video-recorded, and certified by authorised food safety officials.
Source: urli.info/1iRz4

4. Indian medical devices regulator (CDSCO) has issued an updated list of about 1,700 Indian Standards (IS) under the BIS Medical Equipment and Hospital Planning (MHD) division, covering around 20 categories including surgical, diagnostic, orthopaedic, dental, and hospital-planning equipment. All medical devices manufactured, imported, and marketed in India must mandatorily conform to BIS standards for regulatory and quality compliance.
Source: urli.info/1iRz9

5. India’s Health Ministry has proposed amending Schedule H2 of the Drugs Rules, 1945, which contains a category of medicines that are mandated to carry a barcode or QR code on their label, to expand it with a new “Table 2” listing key therapeutic categories vaccines, antimicrobials, narcotic and psychotropic drugs, and anticancer drugs. Stakeholders can submit comments within 30 days.
Source: urli.info/1iRzg

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 Environment, Forest and Climate Change (MoEF&CC) has extended the deadline for filing Annual Returns under the Battery Waste Management Rules, 2022 until 30 September 2025. The previous deadline for filing of Annual Returns was 30 June 2025.
Source: bit.ly/46qdfmG

2. The Indian Government is reportedly set to enforce a Minimum Import Price (MIP) on approximately 10 critical pharmaceutical raw materials including Key Starting Materials (KSMs), Active Pharmaceutical Ingredients (APIs), and drug intermediates used in antibiotics and cholesterol medicines primarily imported from China
Source: bit.ly/3II4D0P

3. The Union Health Ministry is reportedly recommended to remove wholesale licensing requirement for household liquid antiseptics by reclassifying them separately from stronger, hospital-grade variants. This aims to make these products more affordable and widely available in retail stores.
Source: bit.ly/3GEEJdP

4. The Department of Biotechnology (DBT) is inviting proposals to establish Image Informatic Centres aimed at creating AI-powered imaging biobanks. These centres will collect and annotate diagnostic images linked with clinical data to develop AI algorithms for improved disease diagnosis and precision medicine.
Source: bit.ly/3GWmVuG

5. India’s Supreme Court has directed the central government to provide an office space within four weeks for the National Task Force (NTF) set up to address the mental health crisis among students, particularly in medical and higher education institutions. The NTF has faced hurdles in functioning due to the lack of physical infrastructure.
Source: bit.ly/44JT1mr

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. Indian Ministry of Environment, Forest, and Climate Change (MoEF&CC) has introduced the Environment (Construction and Demolition) Waste Management Rules, 2025, effective from April 1, 2026. These Rules apply to construction, demolition, remodeling, renovation, and repair activities, with key provisions on Extended Producer Responsibility (EPR) and waste management plans.
Source: bit.ly/42AOQIu

2. India’s Central Drugs Standard Control Organization (CDSCO) has issued a Standard Operating Procedures (SOPs) to streamline the transfer of drugs manufactured in Special Economic Zones (SEZs) to domestic markets (Domestic Tariff Area) for sale and distribution. SEZ units are exempted from mandatory import and registration requirements, provided these drugs are not diverted for domestic sale and are used exclusively for export purposes.
Source: bit.ly/44ftUYL

3. Pune Municipal Corporation has issued notices to private hospitals instructing to not demand any advance deposit from patients seeking emergency medical care and to strictly follow the Bombay Nursing Home Registration Act, 1949, which forbids demanding any advance deposit from “emergency” patients.
Source: bit.ly/4j52xp2

4. A content creator agreed to remove part of a podcast after a company objected to a guest’s remarks about an antiseptic product. The guest’s claims were considered disparaging. The court-approved settlement also required related social media posts to be deleted to protect the product’s reputation.
Source: bit.ly/42sBOeV

5. A global agricultural company is helping Indian rice farmers adopt eco-friendly farming methods. These practices reduce harmful greenhouse gases. In return, the company will issue its first carbon credits, certified by Gold Standard, which environmentally conscious companies can purchase to offset their emissions.
Source: bit.ly/4iavSgm