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 Delhi high court granted ex-parte interim injunction to major manufacturer of toothpaste, directing social media platforms to take down the defamatory content pending further proceedings which is falsely claiming that Dant Kanti toothpaste causes cancer. The court found the claims prima facie malicious and unsubstantiated.
Source: short-url.org/1l8us

2. The High Court of Bombay has granted permanent injunction protecting registered mark ZERODOL against use of ZEKODOL-P for identical pharma products. Court found strong phonetic and visual similarity, holding confusion in medicines unacceptable. Defendant restrained and directed to pay directed to pay costs.
Source: short-url.org/1qgQf

3. The CDSCO is reportedly set to formally involve Quality Council of India-certified notified bodies in its drug regulatory audit framework to boost coverage and compliance monitoring, addressing capacity constraints in current inspections. The reform, aligned with global standards, would expand third-party audit participation alongside plans to grow internal scientific review teams.
Source: short-url.org/1qgQx

4. The Central Drugs Standard Control Organization will reportedly replace its existing SUGAM regulatory portal with a modern open-architecture digital platform, following approval by the Department of Expenditure. The new system aims to integrate the entire drug regulatory value chain, improve transparency and efficiency, and streamline licence, import/export and regulatory approval processes across India.
Source: short-url.org/1l8uE

5. The National Medical Commission has directed all medical colleges to integrate the HMIS of their attached hospitals with the Ayushman Bharat Digital Mission (ABDM-HMIS) portal within 15 days. Issued under UGMSR 2023 compliance, the move aims to enhance transparency, objective assessments and digital monitoring of medical education standards.
Source: short-url.org/1qgSQ

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. A leading food products manufacturer has moved the Bombay High Court against a YouTube channel alleging that an online video falsely questioned the safety of its product despite regulatory approval. The company contends the content contradicts findings of the Food Safety and Standards Authority of India and seeks removal and restraint to prevent consumer misinformation.
Source: h7.cl/1lpNb

2. India’s Health Ministry has reportedly clarified that failing to prescribe medicines by their generic names constitutes professional misconduct and may attract disciplinary action under National Medical Commission (NMC) regulations. Doctors are required to prescribe drugs legibly and rationally, with State Medical Councils and the NMC empowered to act against violations.
Source: h7.cl/1lpNg

3. European Medicines Agency (EMA) released Revision 3 of its stability testing guideline for marketing authorisation variations. The update clarifies stability data expectations for post-approval changes, aligns with lifecycle management principles, and strengthens requirements for Type I and II variations, supporting quality, safety, and efficacy of medicinal products across the EU.
Source: h7.cl/1lpNi

4. The U.S. Food and Drug Administration has issued two guidance documents clarifying safety reporting responsibilities for sponsors and investigators in investigational drug and device studies, including IND, bioavailability (BA), and bioequivalence (BE) trials. The guidance provides detailed recommendations on adverse event reporting and safety data assessment in clinical research.
Source: h7.cl/1gvVH
Source: h7.cl/1lpNs

5. U.S. President Donald Trump has signed an executive order instructing federal agencies to reclassify marijuana from Schedule I to Schedule III, thereby easing its regulatory status to support medical research. He has also approved a pilot program enabling Medicare reimbursement for products containing CBD, a widely used non-psychoactive cannabis compound.
Source: h7.cl/1lpNy