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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. Delhi High Court has held that English alphabets cannot be monopolised under trademarks law, refusing interim protection to the mark “A to Z” used for pharmaceutical products. The Court held the mark is descriptive, lacking distinctiveness, and cannot bar another company’s use of the letters A and Z, vacating an earlier injunction granted in favour of the company.
Source: h7.cl/1idmr

2. India’s Karnataka High Court has ruled that doctors with an MD in Anesthesiology do not require separate training to prescribe, possess, or dispense essential narcotic drugs for pain relief and palliative care, as Anaesthesiology comprises necessary training prescribed under NDPS Rule and no separate training is essential. The court directed authorities to grant certifications to hospitals designating such practitioners, allowing them to procure and prescribe narcotics.
Source: h7.cl/1idmx

3. Reserve Bank of India (RBI) recently notified the Foreign Exchange Management (Export and Import of Goods and Services) Regulations, 2026, unifying goods and services trade under one FEMA framework. The regulation mandate services-export reporting, strengthen bank monitoring, tighten delayed-proceeds norms, and ease compliance for MSMEs, reflecting services’ role in India’s external sector.
Source: h7.cl/1ncIW

4. India’s Central Government has issued a new Drug Procurement Policy under the Central Government Health Scheme (CGHS), introducing demand-driven bulk purchasing, enhanced quality assurance, and transparent drug procurement processes. The policy aims to ensure uninterrupted medicine access, optimize resource utilization, and strengthen supply chain resilience across all CGHS establishments.
Source: h7.cl/1ncJh

5. India’s central drug regulator approved a record number of Recombinant DNA (r-DNA) origin drugs in 2025, granting permission for 28 new drugs for manufacture and 44 for import and marketing, the highest in five years. Approvals included insulin, oncology and immunology products.
Source: h7.cl/1ncJy

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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. The Pondicherry Drugs Control Department has mandated 100% batch-wise testing of all medicines sold in Pondicherry using Central Drugs Standard Control Organisation-accredited labs. The directive covers pharmacies, wholesalers, clinics, and public and private hospital stores, requiring immediate quality testing for every drug batch.
Source: h7.cl/1mwLy

2. The Central government told the Delhi High Court that judicial orders reducing GST on air purifiers would breach the Constitution’s separation of powers, asserting that GST rate decisions rest solely with the GST Council. It also labelled the PIL seeking medical-device status and tax cut as a “motivated attempt,” warning against judicial overreach.
Source: h7.cl/1hzJ2

3. The Delhi High Court has sought a response on a plea seeking revocation of a patent covering a widely used diabetes and anti-obesity medicine, ahead of its expiry in March. The petition alleges lack of novelty and attempts to extend exclusivity, amid growing interest from domestic manufacturers nationwide.
Source: h7.cl/1mwLG

4. The Medical Device Coordination Group (MDCG) has issued new guidance on post-market surveillance (PMS) for medical devices and IVDs under the EU regulations. The guidance outlines PMS system setup, data collection, analysis, and integration with quality management to ensure ongoing safety, performance, and regulatory compliance across the product lifecycle.
Source 1: h7.cl/1hzJ7
Source 2: h7.cl/1hzJ8

5. India’s central drug regulator, guided by a high-level DCC report, is reportedly launching the second phase of the National Action Plan on Antimicrobial Resistance (NAP-AMR) to combat antimicrobial resistance. Measures include banning OTC antibiotic sales, stamping prescriptions, real-time tracking, promoting new antibiotic R&D, stricter Schedule H/H1 controls, and extended producer responsibility for disposal.
Source: As essential antibiotics fail, regulator mulls R&D push, curbs on misuse
Source: h7.cl/1mwLP

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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 CDSCO has issued detailed FAQs to enhance public awareness regarding the Drugs and Cosmetics (Compounding of Offences) Rules, 2025. The FAQs clarify the procedure for compounding offences, the stage at which an application may be filed, and the information and documentation required to support such applications.
Source: shorturl.at/Mkg3L

2. India’s Central Drug Authority has notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
Stakeholders intending to apply for compounding of offences under these rules are required to submit the application in the prescribed format as a physical copy, along with an advance copy via email to raj[dot]shree64[at]cghs[dot]nic[dot]in, addressed to the Compounding Authority.
Source: h7.cl/1mrDG

3. India’s Delhi High Court directed the Central Health Ministry to respond by January 20, 2026 to a contempt plea alleging illegal operations of online health service aggregators. The petition claims these platforms violate the Clinical Establishments Act by functioning without mandatory registration, posing risks to public health and regulatory compliance.
Source: h7.cl/1hvu5

4. The Delhi government will declare human rabies a notifiable disease, requiring mandatory reporting of all suspected, probable and confirmed cases by government and private healthcare facilities. The move aims to strengthen disease surveillance, enable timely intervention, and support the capital’s goal of eliminating rabies-related human deaths.
Source: h7.cl/1hvts

5. A major infant nutrition manufacturer has initiated a large-scale recall of select infant formula products across multiple countries after detecting a potential toxin contamination linked to a supplier ingredient. No illnesses have been reported. The company is strengthening supply chains, activating alternate suppliers, and increasing production to ensure uninterrupted availability.
Source: h7.cl/1msn9

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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 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

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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 Ministry of Health and Family Welfare has published a draft amendment to the Medical Devices Rules, 2017, proposing changes to labelling requirements for non-sterile and non-measuring medical devices, along with other regulatory updates. Stakeholders’ comments are invited within 30 days of publication of the draft Rules.
Source: h7.cl/1ghFK

2. India’s Bureau of Indian Standards has notified IS 19493:2025 on hospital bill formats, effective 8 December 2025. The standard specifies mandatory and optional billing elements for hospitals, nursing homes, diagnostic centres, and outpatient clinics, aiming to ensure uniformity, transparency, prevent overcharging, and improve clarity for patients and insurers nationwide.
Source: h7.cl/1ghFQ

3. The Supreme Court of India has issued notices to the Centre and all states on a PIL seeking to declare cancer a notifiable disease nationwide. The move aims to ensure uniform reporting, strengthen surveillance, and improve early detection and patient care through a centralized digital registry amid fragmented state-level data.
Source: h7.cl/1ghG2

4. A pharmaceutical innovator has appealed a Delhi High Court order permitting an Indian manufacturer to produce and export semaglutide to markets where patent protection has lapsed. The court declined interim relief, allowing exports to continue.
Source: h7.cl/1lb5k

5. The Ministry of Information and Broadcasting stated that the Information Technology Rules 2021 safeguard free speech while curbing fake and misleading digital content. Publishers of news must follow a Code of Ethics, intermediaries must prevent false information, and a grievance mechanism and fact checking by Press Information Bureau ensure accountability nationally.
Source: h7.cl/1ghGa

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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 Finance Ministry has amended the Narcotic Drugs and Psychotropic Substances Rules, 1985 to replace Form 4A and revise Form 5, tightening procedures for import and export of narcotic drugs. The new rules mandate stricter documentation, separate accounting, monthly returns, transport permits, export-only restrictions, and compulsory surrender of unused morphine, codeine, thebaine and their salts to government facilities.
Source: h7.cl/1l0Dd

2. The Finance Ministry has authorized 15 pharma companies to import morphine, codeine, thebaine and their salts solely for producing export-bound formulations under strict conditions including use within 180 days, limits on waste, and surrender of unused material. The order is valid until December 31, 2027, with import certificates valid for 180 days.
Source: h7.cl/1g7yD

3. The Delhi High Court recorded an undertaking that a major Indian pharmaceutical company will not sell its semaglutide-based drug in India until March 20, 2026 when the secondary patent on the medicine is set to expire of another pharma company, while permitting it to manufacture and export the product to markets where no patent rights exist. The company’s assurance was noted by the court amid ongoing patent disputes, with similar relief previously granted to another domestic manufacturer in related proceedings.
Source: h7.cl/1g7xa

4. The Consumer Protection (Amendment) Bill, 2025, proposes to expand the definition of unfair trade practices to include nondisclosure of key terms and dynamic pricing, algorithmic manipulation of consumer behaviour, and the use of complex barriers that impede cancellations, returns, or opting out of services, thereby strengthening India’s legal framework against dark patterns.
Source: h7.cl/1l0Ca

5. India will reportedly invite the World Health Organization to audit and rate its drug regulatory system, aiming to strengthen quality oversight and restore global confidence in its pharmaceutical sector. The initiative follows recent safety concerns and seeks to align national processes with international regulatory maturity standards.
Source: h7.cl/1l0Ce