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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 Directorate General of Foreign Trade (DGFT), has extended the Annual Remission of Duties and Taxes on Exported Products (RoDTEP) Returns filing deadline for FY 2023-24 from November 30, 2025 to March 31, 2026, with a ₹15,000 composition fee. Missing the extended deadline may lead to denial of RoDTEP benefits or scrip cancellations.
Source: h7.cl/1p1E2

2. The National Pharmaceuticals Pricing Authority (NPPA) has directed manufacturers and marketing companies to revise the Maximum Retail Prices (MRP) of 17 life-saving cancer drugs following their exemption from Customs Duty. Downward change in Duties/taxes should be passed on to consumers at the retail level, Form V must be submitted along with issue of to dealers and NPPA.
Source: h7.cl/1jXJ8

3. The Tea Board of India has issued updated guidelines for tea warehouse licence applications and renewals. The specifications that a warehouse must meet have been specified in the guidelines. Modifications of warehouse license is allowed only for floor area changes, and renewals can be auto-processed. Non-submission of requisite documents may lead to rejection without fee refund.
Source: h7.cl/1p1DR

4. Indian Council of Medical Research (ICMR) has reportedly directed that clinical trials in India focus on local genetics, diets, and lifestyles rather than rely on Western research. The move addresses rising lifestyle diseases and aims to produce more relevant evidence. Multicentre trials with government funding will study therapies suited for Indian patients, potentially improving effectiveness and access.
Source: h7.cl/1p1Ef

5. The Department of Pharmaceuticals has reportedly invited stakeholder comments on the amended list of 354 medical devices exempted from restrictions on global tender enquiries. The exemption, valid until March 31, 2027, allows public procurement agencies to source these devices internationally, subject to review of adequate domestic manufacturing capacity.
Source: h7.cl/1jXJk

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 Delhi High Court restored the Central government’s 2018 ban on fixed-dose combinations (FDCs) of three different drugs used to treat Type-2 diabetes, overturning a lower court’s order. The bench ruled that such combinations must independently prove safety and that regulatory action can be taken based on the likelihood of risk, without proof of actual harm.
Source: h7.cl/1hWHD

2. India’s Ministry of Consumer Affairs has issued show cause notices to major edible oil companies for non-compliance with the amended VOPPA Order, 2025, after inspections of return filings. The Order mandates monthly reporting of production, stocks, imports, dispatches, sales, and consumption of notified edible oil products. Authorities have warned that similar action will be taken against all unregistered units or those failing to file mandatory returns to ensure uniform compliance across the sector.
Source: h7.cl/1mUuB

3. The Indian Pharmaceutical Association-Community Pharmacy Division (IPA-CPD) has urged the Union Health Ministry to amend the Drugs & Cosmetics Rules to re-mandate the red line on antibiotic labels, reinforcing prescription-only status and combating antimicrobial resistance. The request aims to align regulatory provisions with public health communication and discourage self-medication misuse.
Source: h7.cl/1mUuE

4. India’s Ministry of Tourism is promoting medical tourism by easing international patient access through e-Medical visas for modern healthcare and e-Ayush visas for traditional treatments. The initiative supports seamless digital entry, coordinated care, and longer stays, reinforcing government’s efforts to position the country as a global destination for affordable, quality medical and wellness services.
Source: h7.cl/1hWHM

5. The U.S. Food and Drug Administration has requested manufacturers to remove suicidal behaviour and ideation warnings from the labels of GLP-1 receptor agonist drugs after reviewing clinical and real-world data showing no increased risk. This action aligns labels across the class and reflects current evidence from extensive clinical and retrospective analyses.
Source: h7.cl/1mUuJ

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 Central pollution regulator has issued a Notification extending the deadline to 31st December 2024, for submitting quarterly filings for the FY 2023-24 for all entities registered under the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2022.
Source: bit.ly/49ahqlK

2. A District Consumer forum in the State of Maharashtra has held that the refusal of returns by a e-commerce service provider, under a blanket “no-returns” policy constituted a “unfair trade practice” and awarded compensation to consumer whose return of sub-standard product had been rejected.
Source: bit.ly/417xJxQ

3. In a recently published response to a query received by it under the Right to Information Act, 2005, the Delhi Medical Council clarified that, since only medical practitioners registered with the council and having recognized qualifications in Allopathic medicine are permitted to practice medicine in Delhi: Dentists, who are registered with the Dental Council are not licensed to perform aesthetic and cosmetic treatment which is not medically necessary.
Source: bit.ly/3ZbT0Ur

4. After considerable negotiation, India has signed the final act of the Riyadh Design Law Treaty which aims to establish protections for Industrial Design patents, the treaty specifies procedural guardrails which member states can adopt into their own local design patent protection regulations.
Source: bit.ly/3CXRxcH
Source: bit.ly/4f5AYJz

5. The United States Supreme Court has declined to hear petition by manufacturers of tobacco products, challenging the decision of the Federal Government of the United States to include graphic visual warnings on cigarette packets.
Source: bit.ly/415u1EU