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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

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 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
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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 Drugs Standard Control Organization has cancelled the import registration of a cosmetic product after finding misleading drug-related claims on its website, which were inconsistent with the approved product labels, including claims relating to treatment of medical conditions.
Source: h7.cl/1hoPv

2. CDSCO has issued guidelines and SOPs under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, detailing eligibility, application process, authorities, and conditions for compounding certain regulatory offences, enabling settlement through monetary penalties and compliance measures instead of prosecution, supporting ease of doing business while maintaining regulatory oversight.
Source: h7.cl/1mlwh

3. The Food Safety and Standards Authority of India has notified that all amendments to food labelling and display regulations will come into force from 1 July of the year of notification. It has also revised the compliance timeline, extending the mandatory transition period for industry from 180 days to 365 days.
Source: h7.cl/1mlvZ

4. The Union Health Ministry is reportedly in discussions with state drug authorities to consider granting a six-month, case-by-case extension for pharmaceutical companies to comply with revised GMP requirements. The updated Schedule M introduces stricter manufacturing quality standards to align India’s drug production framework with global norms.
Source: h7.cl/1mlw4

5. India’s pharma regulator reportedly plans to introduce a dedicated wholesale licensing regime for bulk drugs, APIs and key starting materials. The move, along with a national supplier database, aims to improve traceability of imported materials and strengthen accountability and supply-chain oversight amid rising quality concerns.
Source: h7.cl/1hoPC

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 Government of India has launched Market Access Support under the Export Promotion Mission to strengthen global market access for Indian exporters. The initiative offers structured support for trade fairs, buyer seller meets, delegations and digital tools, prioritising small exporters, new markets, predictable planning and outcome driven export growth nationwide.
Source: h7.cl/1m6xR

2. The Food Safety and Standards Authority of India (FSSAI) issued an office order mandating a standardized format for food businesses operators, industry bodies, and other stakeholders to submit representations seeking food safety risk assessment. The move aims to ensure complete data submission, improve evaluation, enhance transparency, and speed up regulatory decision-making.
Source: h7.cl/1hakR

3. The Delhi High Court has granted an interim injunction restraining a manufacturer from selling biscuits bearing an identical name, shape and packaging to a registered trademark holder’s product. The court cited prima facie trademark infringement and passing off on triple identity and directed removal of infringing products from the market and e-commerce platforms.
Source: h7.cl/1m6y3

4. The Gujarat High Court has upheld a ruling by the Customs Authority for Advance Rulings allowing duty free import of inshell walnuts by treating the product as “dietary fibre.” The decision confirms that inshell walnuts qualify for exemption from Basic Customs Duty under the Transferable Duty-Free Import Authorization (DFIA) scheme.
Source: h7.cl/1m6y8

5. India’s major pharmaceutical company has signed an exclusive agreement with the other giant to introduce needle-free injection systems for IVF and gynaecology therapies across India. The high-pressure jet delivery tech aims to reduce pain, anxiety and improve patient compliance, with a targeted all-India rollout in FY 2026, addressing millions of injections in the growing fertility market.
Source: h7.cl/1hakq

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. 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

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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 Pollution Control Board (CPCB) has notified the establishment of a National Control Room (NCR) to coordinate and monitor nationwide enforcement of the ban on identified single-use plastic items. The NCR will support clarity, compliance tracking, stakeholder guidance, state control room reporting, inspections and awareness campaigns.
Source: h7.cl/1lmmL

2. The National Medical Commission has directed medical colleges to establish committees to monitor prescription practices, emphasising clear and legible handwriting and the use of generic drug names. The directive aims to strengthen patient safety, promote rational prescribing, and integrate these practices into medical education nationwide.
Source: h7.cl/1lmm6

3. Food Safety and Standards Authority of India has reportedly directed all states and Union Territories to launch a nationwide enforcement drive against adulteration and misbranding of milk, paneer and khoya. The move follows repeated detections and aims to protect public health through strict inspections and penalties across country.
Source: h7.cl/1gsAC

4. More than 60% of registered small and medium pharmaceutical units in India reportedly risk shutting down by December 2025 due to non-compliance with revised GMP (Schedule M) quality standards. Industry stakeholders warn of potential medicine shortages, job losses, and export disruptions if compliance challenges are not addressed promptly.
Source: h7.cl/1gsAd

5. The EU’s Medical Device Coordination Group has issued new guidance clarifying criteria for qualifying breakthrough medical and IVD devices under MDR/IVDR. It defines key criteria such as significant clinical benefit, unmet medical need, and innovation level, aiming to harmonize interpretation across authorities and support early regulatory engagement without lowering safety or evidence requirements.
Source: h7.cl/1lmli

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 food regulator, FSSAI, has reportedly initiated a nationwide surveillance drive to collect and test egg samples (branded and unbranded) for banned antibiotics like nitrofurans. Additionally, FSSAI is also scrutinising declarations such as ‘100% chemical-free’, ‘antibiotic-free’, ‘100% pure’, or ‘fresh’, checking compliance with permissible labelling declarations.
Source: h7.cl/1gl8j

2. India will host the Second World Health Organization Global Summit on Traditional Medicine in New Delhi from 17 to 19 December 2025, bringing global leaders together to strengthen science-based, ethical and sustainable integration of traditional medicine into national health systems and the global health policy framework.
Source: h7.cl/1leF9

3. India’s Parliamentary Standing Committee on Health & Family Welfare has reportedly called on the National Medical Commission (NMC) to issue clear guidelines to establish new medical colleges in states with fewer than 100 MBBS seats per million population, addressing uneven seat distribution, high costs, faculty shortages and access gaps in medical education.
Source: h7.cl/1gl9d

4. The Indian Council of Medical Research has reportedly funded a pan India clinical trial, Intermittent PARP Inhibitor Regimen in Ovarian Cancer, to evaluate intermittent dosing of the PARP inhibitor rucaparib in ovarian cancer, aiming to reduce treatment costs and side effects while maintaining clinical efficacy and improving patient access.
Source: h7.cl/1leFj

5. The Telangana Drugs Control Administration conducted a statewide inspection of retail medical shops and raided an unlicensed fertility centre, issuing notices to 180 outlets and seizing multiple medicines, reinforcing enforcement against illegal drug sales and violations of the Drugs and Cosmetics Act, and ensuring patient safety across the state.
Source: h7.cl/1gl8A

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 Drugs Consultative Committee (DCC) has approved a proposal to delete the exemption under Entry 13 of Schedule K for cough syrups. The move follows recent incidents involving deaths linked to contaminated cough syrups.
Source: h7.cl/1ft5I

2. The Drugs Consultative Committee (DCC) has observed gaps in monitoring drug marketers’ responsibility for product quality, safety, and efficacy, as their details are often unavailable for regulatory communication. To enhance accountability, the DCC has recommended amending the Drugs Rules, 1945 to mandate a licensing framework for all drug marketers.
Source: h7.cl/1kjPG

3. India is reportedly planning to introduce a Quality Control Order (QCO) requiring Bureau of Indian Standards compliance for food-processing machinery, aiming to curb unsafe imports, especially from China. The measure seeks to improve equipment reliability, ensure food-grade materials, strengthen domestic manufacturing, and minimise disruption for smaller processors across the industry.
Source: h7.cl/1ft5T

4. The government will reportedly introduce a Bill in the Lok Sabha seeking a new “health & national security” cess to replace the expiring GST compensation cess on cigarettes, pan masala, gutkha and other tobacco products. The aim is to keep overall tax incidence unchanged, sustaining high indirect-tax levels on “sin goods” while tying levy proceeds to public-health and national-security objectives.
Source: h7.cl/1kjPJ

5. The Food Safety and Standards Authority of India (FSSAI) has directed all state and central food-safety authorities to conduct inspections, sampling and testing of roasted chana and similar products following complaints that the banned industrial dye Auramine, which is not permitted under food-safety rules, was being illegally used for colouring. The order mandates action across manufacturing, storage, distribution and e-commerce channels and requires a consolidated compliance report to be submitted within 15 days.
Source: h7.cl/1kjQl