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 drug regulator, CDSCO has requested state drug regulators to direct manufacturers of Carbimazole formulations to incorporate agranulocytosis as an adverse drug reaction in Prescribing Information Leaflets (PIL) following recommendation by the Subject Expert Committee on Endocrinology and Metabolism.
Source: short-url.org/1pcz1

2. The Central Pollution Control Board (CPCB) has introduced a Common EPR Portal to unify all Extended Producer Responsibility activities under one platform. Through Single Sign-On (SSO), users can access Plastic, E-Waste, Battery, Tyre and Used Oil Management portals, and the EPR Trading Platform with one login. Registration is mandatory, with no additional fee.
Source: short-url.org/1pcz4

3. The Madras High Court has reportedly strongly criticised the practice of imposing non-compete and non-solicitation clauses on doctors in employment contracts, calling such restrictive covenants “unlawful on the face of it” and questioning their enforceability in healthcare settings. The bench indicated it will discourage hospitals from using these clauses, emphasising doctors’ freedom to practice and patient choice.
Source: short-url.org/1pcz6

4. The National Pharmaceutical Pricing Authority has reportedly deferred a decision on creating a separate price ceiling for cementless knee implants. The Multidisciplinary Committee will invite subject experts and manufacturers for detailed deliberations. Until a final determination is made, all companies must continue complying with the existing ceiling prices.
Source: short-url.org/1k7in

5. India’s drug regulator CDSCO is enhancing the online WHO-GMP Certificate of Pharmaceutical Product (CoPP) application via its ONDLS portal, partnering with C-DAC and state authorities to replace manual submissions. The digital shift aims to cut delays, improve transparency, and boost export readiness for Indian pharma manufacturers.
Source: short-url.org/1pcze

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 Electronics and Information Technology has notified phased enforcement of the Digital Personal Data Protection Act 2023. Implementation will follow a phased timeline of 12-18 months, introducing consent-based processing, mandatory breach reporting, children’s safeguards, expanded data rights, and a digital-only Data Protection Board, marking the structured rollout of India’s data protection framework.
Source: minilink.pro/1jA7S

2. India’s Ministry of Electronics and Information Technology (MeitY) has recently notified the Digital Personal Data Protection Rules, 2025. The rules mandate clear consent, breach reporting, children’s data safeguards, and a digital-only Data Protection Board. Compliance is phased over 18 months, along with penalties for violations.
Source: minilink.pro/1eLQj

3. The National Pharmaceutical Pricing Authority has extended the existing ceiling prices for orthopaedic knee implants by one more year until November 15, 2026. Manufacturers and importers of orthopaedic knee implants will have to maintain the existing prices till November 15, 2025.
Source: minilink.pro/1jA8h

4. The Food Safety and Standards Authority of India has integrated its Food Import Clearance System with the Central Board of Indirect Taxes and Customs under the SWIFT 2.0 platform. This integration enables faster, more transparent, and technology-driven food import clearance, reducing delays, improving efficiency, and supporting India’s broader trade facilitation objectives.
Source: minilink.pro/1jA97

5. The Union Cabinet has approved the Credit Guarantee Scheme for Exporters (CGSE), offering up to INR 20,000 crore in collateral-free credit with 100 % guarantee via National Credit Guarantee Trustee Company (NCGTC). Including both MSME and non-MSME exporters, the scheme aims to boost liquidity, aid market diversification, and enhance global competitiveness of Indian exports.
Source: minilink.pro/1eLQH

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 NPPA has extended the existing ceiling prices for orthopaedic knee implants until November 15, 2025. The earlier deadline was September 15. The extension allows time to review industry representations while maintaining current ceiling prices.
Source: short-url.org/1eQeU

2. India’s central drugs regulator, has introduced a new online provision, effective 11th September 2025 for “Subsequent Importer” applications. It allows companies to import medical devices and in-vitro diagnostics already approved by CDSCO for marketing in India. The initiative aims to simplify approvals, brand approvals, enhance transparency, and reduce processing timelines.
Source: short-url.org/1eQnm

3. India’s central drug authority has classified pharmaceutical cocrystals of approved active substances as new drugs under New Drugs and Clinical Trials Rules, 2019. Applicants must demonstrate superior properties over physical mixtures, with detailed validation, stability, and bioavailability/bioequivalence data. Submissions will be processed like new active substances, requiring full safety and efficacy evidence.
Source: short-url.org/1afgK

4. Pharmaceutical merchant association are reportedly urging India’s government to revise the rule prohibiting the export of pharmaceutical products labelled “For sale in India only.” They claim the regulation has led to substantial losses, hurting global competitiveness, restricting access for overseas patients, and causing market-share losses.
Source: short-url.org/1eQme

5. Reportedly, one of the leading toothpaste maker company in the United States will update its packaging from November 1 under a settlement order, showing “pea-sized” amounts for children under six to promote safe, age-appropriate fluoride use and address concerns that previous images encouraged potentially unsafe overuse by young children.
Source: short-url.org/1afh5

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 National Pharmaceutical Pricing Authority (NPPA) plans to consult subject matter experts to determine a separate pricing structure for cementless knee implants, aiming to ensure affordability and accessibility for patients requiring these advanced medical devices.
Source: bit.ly/43XywRM

2. The Indian Pharmaceutical Alliance (IPA) has expressed opposition to the government’s recent directive limiting the entry of medical representatives into Central government hospitals, arguing that such restrictions could hinder the dissemination of critical medical information to healthcare professionals.
Source: bit.ly/4kDnNCZ

3. The Ministry of Electronics and Information Technology (MeitY) is considering the discontinuation of the bundled consent mechanism, proposing stricter regulations to enhance data privacy and security standards in digital platforms.
Source: bit.ly/4kE8qdH

4. India has asserted its stance on protecting pharmaceutical innovations, countering recent patent infringement allegations from Switzerland, and emphasizing the country’s commitment to safeguarding public health interests.
Source: bit.ly/4n66Lzd

5. The U.S. Department of Agriculture is set to introduce new dietary guidelines for schools, aiming to reduce added sugars and sodium in meals, promote plant-based options, and support local agriculture, thereby enhancing student health and nutrition.
Source: bit.ly/3Hzzv2P