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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. The Pondicherry Drugs Control Department has mandated 100% batch-wise testing of all medicines sold in Pondicherry using Central Drugs Standard Control Organisation-accredited labs. The directive covers pharmacies, wholesalers, clinics, and public and private hospital stores, requiring immediate quality testing for every drug batch.
Source: h7.cl/1mwLy

2. The Central government told the Delhi High Court that judicial orders reducing GST on air purifiers would breach the Constitution’s separation of powers, asserting that GST rate decisions rest solely with the GST Council. It also labelled the PIL seeking medical-device status and tax cut as a “motivated attempt,” warning against judicial overreach.
Source: h7.cl/1hzJ2

3. The Delhi High Court has sought a response on a plea seeking revocation of a patent covering a widely used diabetes and anti-obesity medicine, ahead of its expiry in March. The petition alleges lack of novelty and attempts to extend exclusivity, amid growing interest from domestic manufacturers nationwide.
Source: h7.cl/1mwLG

4. The Medical Device Coordination Group (MDCG) has issued new guidance on post-market surveillance (PMS) for medical devices and IVDs under the EU regulations. The guidance outlines PMS system setup, data collection, analysis, and integration with quality management to ensure ongoing safety, performance, and regulatory compliance across the product lifecycle.
Source 1: h7.cl/1hzJ7
Source 2: h7.cl/1hzJ8

5. India’s central drug regulator, guided by a high-level DCC report, is reportedly launching the second phase of the National Action Plan on Antimicrobial Resistance (NAP-AMR) to combat antimicrobial resistance. Measures include banning OTC antibiotic sales, stamping prescriptions, real-time tracking, promoting new antibiotic R&D, stricter Schedule H/H1 controls, and extended producer responsibility for disposal.
Source: As essential antibiotics fail, regulator mulls R&D push, curbs on misuse
Source: h7.cl/1mwLP

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 Supreme Court of India has urged the Union Government to consider giving legal backing to the Uniform Code of Pharmaceutical Marketing Practices, 2024, noting that the current voluntary framework lacks effective enforcement and leaves patient unprotected. The Court indicated it may issue interim guidelines and sought detailed proposals for a statutory, government-enforced framework.
Source: h7.cl/1jDIt

2. The Competition Commission of India (CCI) has approached the NCLAT to clarify whether privacy safeguards for non-advertising data sharing should also apply when a social media platform shares user data with its parent company for advertising purposes. This follows the lifting of a five-year ban on such data sharing,
Source: h7.cl/1ePhT

3. India’s central drug regulator (CDSCO) reportedly plans for a digital tracking system for high-risk solvents like diethylene glycol and batch-level reporting to prevent cough-syrup contamination. Authorities are also increasing scrutiny of unlicensed rural pharmacies and considering removal of the Schedule K exemption that currently eases regulatory requirements for selling cough syrups.
Source: h7.cl/1ePhW

4. The Directorate General of Foreign Trade (DGFT) has resolved a long-standing issue affecting pharmaceutical exporters by clarifying redemption of Advance Authorisations (AAs) impacted by the old CGST Rule 96(10). The move addresses compliance hurdles for duty-free raw material imports for the pharma sector.
Source: h7.cl/1jDHw

5. Indian government has launched the National Action Plan on Antimicrobial Resistance (NAP-AMR) 2.0 (2025–29) to counter rising drug resistance. The plan sets clear timelines, strengthens surveillance, curbs antibiotic misuse, boosts lab and infection-control capacity, and adopts a One Health approach through coordinated, multi-ministerial action against the growing AMR threat.
Source: h7.cl/1jDHD