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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 Food Safety and Standards Authority of India has issued draft amendments to the Food Business Licensing Regulations mandating food manufacturers to keep daily production and raw-material records and to follow FIFO/FEFO storage norms. Retailers and non-manufacturers are exempt. The move strengthens traceability, inventory control, and food safety compliance. Public comments are invited within 30 days of Gazette publication.
Source: h7.cl/1iFOX

2. Madras High Court has ruled that the word “Vapo” is a descriptive and generic term derived from “vapour” and cannot be claimed exclusively by any party, rejecting petitions seeking cancellation of trademarks for “Vaporin” products. The Court held that the rival marks and trade dress are distinct and unlikely to cause consumer confusion.
Source: h7.cl/1nG6S

3. India’s Central Government has amended Uniform Consent Guidelines under the Air and Water Acts to simplify industrial approvals and cut delays. Key changes include consolidated consents covering multiple environmental laws, faster timelines for red-category industries, and Consent to Operate remaining valid until cancelled. Inspections, audits, and cancellation powers remain to ensure environmental compliance.
Source: h7.cl/1iFAP

4. The India–EU free trade agreement is set to eliminate duties on about 90% of European medical devices imported into India, reducing tariffs that earlier went up to 27%. The agreement is expected to lower costs and improve access to advanced technologies, Indian manufacturers are seeking regulatory alignment and mutual recognition to overcome non-tariff barriers.
Source: h7.cl/1iFAU

5. The India–EU Free Trade Agreement is expected to expand opportunities for Indian traditional medicine in Europe. In EU countries where no specific regulations exist, AYUSH practitioners will be allowed to offer services based on their Indian qualifications. The agreement also provides long-term certainty for setting up AYUSH wellness centres and clinics across EU member states.
Source: h7.cl/1iFAX

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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 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

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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 Department of Pharmaceuticals has invited proposals under the CFMDC scheme to strengthen shared testing infrastructure for medical devices, including cardiac and orthopaedic implants, infusion pumps, endoscopic systems, imaging equipment such as X-ray and MRI, and Class B, C, and D IVDs. The initiative aims to improve access to common testing facilities in India.
Source: h7.cl/1hMz2

2. The Department of Pharmaceuticals (DoP) has issued a public notice proposing the inclusion of 11 additional pharmaceutical formulations, including patented biologics and proprietary insulin products, under the Global Tender Enquiry (GTE) exemption list for FY 2025–26. Domestic manufacturers have been invited to submit objections by January 19, 2026, in the attached form.
Source: h7.cl/1hMz7

3. The Supreme Court of India has issued notices to the Union Ministries of Law, Health and AYUSH on a PIL seeking to declare AYUSH practitioners as Registered Medical Practitioners (RMP) under the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954. An RMP is allowed to display a signboard or notice on their clinic premises indicating that they provide treatment for diseases listed in the Act, which others are prohibited from advertising.
Source: h7.cl/1hMz8

4. Delhi High Court held that in patent disputes involving life-saving drugs, courts must prioritise public interest. Injunctions should not block patient access unless infringement is clearly established through product-to-claim mapping. Where issues are technical and triable, alternative safeguards can protect patentees without withdrawing essential therapies during litigation.
Source: h7.cl/1mK20

5. Indian importers of aluminium beverage cans are reportedly requesting the government to extend the deadline for BIS certification and marking requirements. This follows shortages caused by rising demand and delays in BIS approvals. The quality control order was issued in April 2025, beverage companies have increased imports from West Asia and Sri Lanka to prevent supply disruptions.
Source: h7.cl/1hMzd

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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 Kerala High Court ruled that brand ambassadors are not liable for unfair trade practices or deficient services under the Consumer Protection Act unless a direct transactional link with consumers is proven. Endorsers face penalties only for misleading advertisements, and are protected where due diligence to verify claims is demonstrated by law.
Source: h7.cl/1hJqC

2. State Drugs Regulator of Telangana has recently issued a stop-use advisory for a children’s syrup prescribed for allergies, hay fever, and asthma, after a CDSCO lab detected toxic ethylene glycol contamination. The public was advised to stop use immediately, report possession, and authorities ordered freezing of affected stocks to avert health risks.
Source: h7.cl/1mGN8

3. A Parliamentary Standing Committee has urged the Ministry of AYUSH to integrate allopathy and traditional medicine, recommending AYUSH departments in all AIIMS, stronger collaboration with the Health Ministry, and time-bound action to create a pluralistic, integrated healthcare system nationwide.
Source: h7.cl/1mGNc

4. The Bureau of Indian Standards has notified amendments to 22 Indian Standards covering dairy products, infant foods, milk substitutes, and special medical nutrition. Amendments were established from 15 December 2025, and existing standards will remain in force till 14 June 2026, giving business operators a defined transition period for compliance.
Source: h7.cl/1hJqz

5. The US Food and Drug Administration has relaxed the oversight of general wellness devices, clarifying that low-risk products such as fitness trackers and wellness apps will not be actively regulated as medical devices if they avoid disease-related claims. The move aims to reduce regulatory burden and encourage innovation in consumer and digital health technologies.
Source: h7.cl/1hJqP
Source: h7.cl/1hJqT

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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 Drug Controller General (DCGI) has reaffirmed that the revised Schedule M good manufacturing practice norms will be enforced as scheduled from January 1, 2026, with no further extensions even amid industry calls for delays. The rule applies to all drug makers and aims to elevate quality standards, though many MSMEs cite compliance challenges and potential business impacts.
Source: h7.cl/1h1Ta

2. The Department of Pharmaceuticals has extended the deadline for manufacturers to apply under the Production Linked Incentive (PLI) Scheme for domestic manufacturing of critical KSMs, drug intermediates, and APIs until 16 January 2026. Applications must be submitted online through the designated portal, and all previously issued terms and conditions in the earlier notice will continue to apply.
Source: h7.cl/1lXQo

3. A plea filed recently in India’s Supreme Court, reportedly, argues that the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is outdated. It seeks recognition of AYUSH doctors as registered medical practitioners and calls for reforms to curb misleading drug advertisements while allowing truthful, evidence-based information.
Source: h7.cl/1lXPt

4. India is considering waiving customs duty on select pharmaceutical products manufactured in special economic zones and sold in the domestic market. The proposal aims to boost investment, strengthen domestic supply of critical medicines and vaccines, and support the pharmaceutical sector amid rising global trade pressures.
Source: h7.cl/1h1Ti

5. Australian health authorities had recently flagged concerns over counterfeit batches of anti-rabies vaccine circulating in India. The public sector manufacturer clarified that the issue pertained to a specific counterfeit batch identified in January 2025 which has since been removed from circulation. The company emphasized that genuine vaccines released through authorized channels remain safe.
Source: h7.cl/1lXPz

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 government has reportedly updated the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) policy, mandating a 500-metre minimum distance between Jan Aushadhi stores in major urban centres to protect existing outlets’ financial viability while continuing expansion of affordable generic drugs across the nation. Major metros and million-plus cities are in scope; exemptions apply for government hospitals.
Source: h7.cl/1gK1R

2. The Parliamentary Panel on Health and Family Welfare has urged the Ministry of Ayush to introduce strict penal provisions against false and misleading advertisements, strengthen enforcement mechanisms, improve public awareness, ensure transparency in action taken, and prioritise establishment of Ayush institutes and Yoga Ashrams in underdeveloped states.
Source: h7.cl/1lEmX

3. The Food Safety and Standards Authority of India clarified that eggs sold in the country are safe for consumption and claims linking them to cancer are misleading. It stressed that nitrofuran residues are strictly regulated, trace detections pose no health risk, and consumers should rely on verified scientific evidence.
Source: h7.cl/1gK2z

4. India’s central food authority (FSSAI) has issued a Scheme of Testing for Packaged Drinking Water (PDW) and Mineral Water (MW) to ensure product safety after removing mandatory BIS certification. Effective January 1, 2026, all food business operators must follow detailed microbiological, chemical and packaging testing protocols and maintain compliant batch records via FSSAI-notified NABL labs.
Source: h7.cl/1lEoa

5. The WHO and India’s Ministry of AYUSH held a two-day technical meeting in New Delhi to develop a dedicated Traditional Medicine module within the International Classification of Health Interventions (ICHI), aiming to standardise Ayurveda, Siddha, and Unani globally. India is providing financial and technical support, with expert and member-state participation to strengthen evidence-based global health standards.
Source: h7.cl/1gK2s

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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 World Anti-Doping Agency will reportedly classify non-diagnostic use of carbon monoxide to its prohibited method list while preserving its controlled medical and diagnostic use. WADA reportedly said that its use could increase erythropoiesis – the process of creating new red blood cells.
Source: short-url.org/1bq0M

2. The Indian Supreme Court has recently clarified that under the Maintenance and Welfare of Parents and Senior Citizens Act, 2007, the applicant’s eligibility as a senior citizen is determined on the date of filing the application, not when it is adjudicated. The ruling ensures timely recognition of rights and prevents denial of benefits due to procedural delays.
Source: short-url.org/1g4st

3. The Kerala High Court has called on the State Government to consider setting up dedicated Narcotic Drugs and Psychotropic Substances courts in every judicial district to clear the pending cases and enable speedy trials as there are only two special courts currently operational.
Source: short-url.org/1g4sw

4. Odisha government plans to expand Ayurvedic infrastructure by launching integrated AYUSH hospitals, Panchakarma centers, and Ayurvedic colleges. The state aims to boost Ayurvedic education, treatment, and preventive healthcare under the National AYUSH Mission to ensure wider public access.
Source: short-url.org/1g4sC

5. The U.S. Department of the Treasury’s OFAC has sanctioned two Indian nationals, and their India-based pharmacy for supplying hundreds of thousands of counterfeit prescription pills laced with fentanyl and methamphetamine to U.S. consumers.
Source: short-url.org/1g4sI

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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 Central Mental Health Authority (CMHA) has amended the Central Mental Health Act and introduced a five-category classification for mental health establishments covering spanning stand-alone mental hospitals to psychosocial rehabilitation centres. All the establishments are mandated to register with the Authority effective immediately.
Source: short-link.me/175VU

2. India’s Central Food authority (FSSAI) has amended the Labelling and Display Regulations, 2025 which requires all “Coffee Blended with Chicory” or “Instant Coffee-Chicory Mixture” packages to clearly declare the percentage of coffee and chicory on the front label starting July 1, 2026.
Source: short-link.me/175Xx

3. The Karnataka High Court held that exporters should not be denied incentives over a technical mistake such as ticking “No” instead of “Yes” for reward claims in a shipping bill especially when the intent to claim was clear elsewhere. Even if submitted via restrictive online systems, procedural inflexibility cannot override principles of natural justice.
Source: short-link.me/1bxwd

4. India’s Central Food authority (FSSAI) in a recent stakeholder’s meeting stressed on ethical food labelling, advertising and scientific claims, calling for external validation to curb misleading practices. It announced that label changes will be implemented annually, giving businesses predictability while strengthening consumer protection and trust in food safety regulations.
Source: short-link.me/1bxwn
  
5. The Ministry of Ayush and India’s Central Food authority (FSSAI) has recently unveiled a curated list of over 90 “Ayurveda Ahar” food products (e.g., khichdi, curds, soups), grounded in classical Ayurvedic texts. These standardized recipes aim to promote preventive health, support Indian manufacturers, and cultivate both domestic and global markets.
Source: short-link.me/1bxwu

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 Indian Council of Medical Research and India’ central drug authority “CDSCO” have released draft standard protocols for evaluating In-Vitro Diagnostic kits for Influenza, SARS-CoV-2, RSV, Malaria, Dengue, Nipah, and other pathogens. Pharma and diagnostics stakeholders can submit comments by 25 August 2025, after which revisions will be minimal before final adoption.
Source: short-link.me/1b0iM

2. India’s Supreme Court has disposed of a plea challenging misleading AYUSH medicine ads and vacated its stay on the omission of a rule which had removed the requirement for state-level pre-approval of Ayurvedic, Siddha, and Unani drug advertisements. With the rule deleted, companies can advertise without state clearance.
Source: short-link.me/16ALo

3. The All India Organisation of Chemists and Druggists has urged the government to ban ultra fast ten minute delivery of high risk prescription medications by quick commerce platforms, citing threats to public health, rising drug misuse, ghost prescriptions, and a disregard for established regulatory safeguards.
Source: short-link.me/1b0iY

4. India’s Health Ministry has launched SHRESTH Index to benchmark and strengthen state drug regulatory systems. The data-driven framework will guide improvements in infrastructure, manpower, digitization, inspections, and grievance redressal. Upcoming measures include expanding the Not of Standard Quality (NSQ) Dashboard to all states as well.
Source: short-link.me/1b0j6

5. India’s public health organisations call for mandatory front of pack warning labels on food items high in fats, sugar, and salt, replacing Indian Nutrition Rating (or Health Star Rating) system. They cite rising diet related deaths and rapid ultra processed food growth.
Source: short-link.me/16ALH

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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 Indian Government has issued the Medical Textiles (Quality Control) Second Amendment Order, 2025. As per this amendment, any manufacturer or importer certified by the Bureau, or those who have applied for certification, and who have declared their existing stock of products, manufactured or imported prior to the implementation date specified in the principal order dated 23rd October 2024, will be permitted to sell, offer for sale, or display such non-BIS-marked stock until 31st December 2025.
Source: short-link.me/19ypP
Source: short-link.me/19yp3
Source: short-link.me/19ypb

2. India’s Ministry of Environment, Forest and Climate Change has extended the deadline for filing annual returns by Producers, Importers, Brand Owners, and Plastic Waste Processors for Year 2024-25 till 30th September 2025.
Source: short-link.me/15cIv

3. The Indian government has implemented a Central Sector Scheme to promote awareness about Ayurveda, Yoga, Unani, Siddha, and Homoeopathy through fairs, media campaigns, research, and quality certification. Measures also include strengthening drug testing, safety monitoring, international collaborations, and regulatory compliance for traditional medicine systems.
Source: short-link.me/19yqL

4. The Ministry of AYUSH has implemented the Central Sector Scheme “AYURGYAN” to boost research, education, and innovation in traditional medicine. It supports capacity building, clinical research, and interdisciplinary studies, including Ayurveda biology. The scheme promotes evidence-based AYUSH practices through collaborations with academic institutions and national research councils.
Source: short-link.me/19yqQ

5. Food Safety and Standard Authority of India has recently issued an advisory directed all licensed food businesses to display the QR code or download link of the “Food Safety Connect” app at their premises. This enables consumers and regulators to verify license details and lodge complaints easily, promoting transparency, digital access, and improved compliance in the food safety ecosystem.
Source: short-link.me/19yqW