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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. 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

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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 Central Drug authority (CDSCO) is considering a separate wholesale licence for bulk drugs and excipients to distinguish them from APIs and finished formulations. The proposal includes capturing details of wholesalers handling NDPS substances and requiring competent persons to be either science graduates with relevant experience or registered pharmacists, strengthening oversight and regulatory compliance.
Source: h7.cl/1fZHk

2. India’s Drugs Consultative Committee addressed non-compliance issues in hospital blood centres and directed states to strengthen oversight. Key actions include regular inspections with focus on viral marker testing, adherence to NBTC licensing procedures for charitable and voluntary centres, and timely licence renewals. States were urged to ensure strict compliance to maintain a safe blood supply.
Source: h7.cl/1fZHk

3. The Indian Pharmacopoeia Commission will release the tenth edition of the Indian Pharmacopoeia on January 2, 2026, with standards effective from July 1, 2026. The new edition adds 121 monographs, five general chapters, and expanded harmonization to strengthen drug quality and regulatory alignment in India.
Source: h7.cl/1kRtQ

4. The Central Consumer Protection Authority (CCPA) imposed a penalty on e-commerce platform for allowing the sale of walkie-talkies without mandatory disclosures on regulatory approvals. This suo motu action stemmed from listings that omitted details on spectrum compliance, frequency usage, potentially misleading consumers about the devices’ legality and exposing them to risks.
Source: h7.cl/1kRwR

5. The Central Pollution Control Board (CPCB) has released a comprehensive guide on ticket creation to help producers navigate the Extended Producer Responsibility (EPR) portal for battery and e-waste management. The guide aims to streamline communication between producers and the regulator for all EPR-related queries.
Source: h7.cl/1fZK0

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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. General insurers are reportedly urging the Indian Finance Ministry to exempt commissions on health insurance from the 18% GST and reinstate input tax credit (ITC), arguing that commissions part of procurement costs should be treated like reinsurance commissions. Without relief, premiums could increase by ₹3-5 per ₹100 cover, hitting India’s ₹40-50k crore retail health insurance market.
Source: short-url.org/1antS

2. India’s Supreme Court has allowed Major Electronics company to be exempted from customs duty on its G Watch W7 imports from South Korea, even though it was classified under the higher duty category (CTH 8517). The court held that a certificate of origin from a country with which India has a full customs duty exemption agreement is sufficient to claim such exemption.
Source: short-url.org/1anu0

3. India’s Tamil Nadu Medical Council (TNMC) has issued a notice classifying “conversion therapy” as a professional misconduct. It warned that doctors attempting to alter a person’s sexual orientation or gender identity will face strict disciplinary action, including suspension or cancellation of their medical license, reinforcing ethical practice and safeguarding LGBTQIA+ rights across the medical community.
Source: short-url.org/1anvQ

4. Private hospitals in India are locking horns with insurers over reimbursement rates and delayed settlements as medical inflation surges. Some renowned hospitals have suspended cashless services in August. Policyholders are bearing the financial burden amid this impasse.
Source: short-url.org/1anuR

5. The Supreme Court ruled that under the NDPS Act, failure to produce the bulk of seized contraband at trial doesn’t fail the prosecution’s case, provided inventory, sample-drawing and forensic report are properly documented. The court emphasized that only in exceptional cases, where procedural breach undermines the case’s core, should retrial be ordered.
Source: short-url.org/1anv0

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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 mandates all WHO-GMP (COPP) certificate applications to be submitted exclusively through the ONDS Portal from June 15, 2025. Hard copy submissions will not be accepted. A step-by-step procedure and contact details for support have also been provided.
Source: bit.ly/3HWGXWd

2. CDSCO has informed all states and union territories that a loan license is no longer required for outsourcing sterilization of medical devices, provided the sterilization facility is licensed under MDR-2017. Manufacturers must submit documentation and include the sterilization site’s license number on labels of the device.
Source: bit.ly/44nGKCX

3. The Bombay High Court has issued an interim injunction restraining a company from using packaging, labels, bottles, and trade dress that closely resemble those of an established hair-oil brand. The court found that the packaging was “slavishly copied,” potentially misleading consumers and amounting to trademark infringement and unfair competition.
Source: bit.ly/4kd5DXM

4. The Andhra Pradesh High Court has ruled that under the Narcotic Drugs and Psychotropic Substances Act, 1985, “Ganja” refers only to the flowering or fruiting tops of the cannabis plant, explicitly excluding seeds and leaves when not accompanied by the tops.
Source: bit.ly/4ls1iRl

5. India’s Central Board of Indirect Taxes and Customs (CBIC), following DGTR recommendations, has slapped anti dumping duties for five years on four key chemicals from China—PEDA, acetonitrile, Vitamin A palmitate and insoluble sulfur—to shield domestic pharma, agro and rubber industries, signalling a strategic push to rebalance imports and promote local manufacturing.
Source: bit.ly/4lNeEYX

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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 Rajasthan High Court has ruled that retesting or resampling of Narcotic and Psychotropic drugs should not be a routine and must be allowed in exceptional circumstances. Applications must be made within 15 days of receiving the test report from Forensic Science Laboratory.
Source: bit.ly/4lDwRZu

2. The Supreme Court of India has ruled that dealing with substances listed in the Schedule of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, even if not listed in Schedule I of the NDPS Rules, is still an offence.
Source: bit.ly/4jGg0TY

3. A preliminary inquiry reportedly revealed that eight doctors and an associate professor at a Ahmedabad Municipal Corporation (AMC) college conducted unauthorized drug trials on patients with 50+ pharma companies since 2021. Payments were deposited into the doctor’s personal accounts. AMC has suspended the staff involved.
Source: bit.ly/4jGg1Y2

4. The Central Board of Indirect Taxes and Customs has issued instructions to the officers processing GST registration to request only specified documents and avoid raising notices for minor issues. The move is intended to minimize delays and improve ease of doing business.
Source: bit.ly/4jglvJf

5. The Patna High Court has upheld Rule 6 of the Bihar Pharmacist Cadre Rules, 2014, stating that a D. Pharm is mandatory for pharmacist posts in the Bihar Health Department, even for candidates holding higher qualifications like B. Pharm or M. Pharm.
Source: bit.ly/3RteFnB

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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 Bombay High Court is set to decide whether donuts and cakes should be classified under restaurant services or as separate bakery products under the Goods and Services Tax (GST) framework. The former attracts a 5% GST, while the latter could be taxed up to 18%. This decision has the potential to impact the broader food service and bakery industries, as this classification may lead to higher prices for the end consumers.
Source: bit.ly/4hdF4Aj
Source: bit.ly/3F4Nw7H

2. India’s Gujarat High Court has directed enforcement of noise pollution control rules, and to frame a policy for tackling noise pollution. This direction is pursuant to alleged non-implementation of Supreme Court’s existing ruling and a notification issued by the Gujarat Pollution Control Board for noise pollution.
Source: bit.ly/4iiEcv8

3. India’s Kerala High Court has ruled that adoption by step-parent cannot be permitted unless the biological parent of the child gives consent for adoption. The court emphasized that in child custody cases, adoption without consent can have serious repercussions like denial of custody to biological parent.
Source: bit.ly/3QMfbww

4. India’s Bombay High Court has described drug addiction as a “quasi-pandemic” and has called for the implementation of a model first information report (FIR) issued by the Bureau of Police Research to address the issue of procedural irregularities and to standardize the investigations in Narcotic Drugs and Psychotropic Substances Act (NDPS Act) cases.
Source: bit.ly/4ij5guo

5. Medical tourism in India is reportedly set to receive increased investment. Further, telemedicine facilities are set to be introduced at all Primary Health Centers (PHCs), making healthcare more accessible, especially in rural areas.
Source: bit.ly/3QLT5dz

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 Control Board (CPCB) has extended the timelines for the filing of Extended Producer Responsibility (EPR) annul returns by producers of Battery waste and E-waste for the Financial Year (FY) 2023-2024 till 31st March 2025 and 31st January 2025 respectively. For E-waste the extension of timelines also applies to the filing of quarterly returns for the abovementioned FY.
Source: bit.ly/3WthHei
Source: bit.ly/4gcsPmW

2. India’s National Pharmaceutical Pricing Authority (NPPA) has issued an office memorandum (OM) requesting manufacturers and marketing companies of the scheduled formulations nicotine used for nicotine replacement therapy (NRT) to furnish the Price to Retailer (PTR) and Moving Annual Turnover (MAT) data, in value terms for October 2023, within 7 days from the issue of the OM. A format for submitting these details is also provided in the OM. This information is being sought to fix the ceiling prices of these formulations.
Source: bit.ly/4gnoEFb

3. India’s Central Drugs Standard Control Organization (CDSCO) has released a guidance document to support the development of rapid diagnostics for pathogen identification and Antimicrobial Susceptibility Testing (AST). The document offers guidance to innovators and developers on evaluating their tests and demonstrating their effectiveness.
Source: bit.ly/4heX8ue

4. The Kerala High Court (KHC) recently ruled that magic mushrooms are not classified as narcotic substances under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. After reviewing the legal status of psychedelic fungi, the honourable court concluded that since magic mushrooms are not specifically scheduled under Act, they are not subject to its restrictions.
Source: bit.ly/3CiZv0k

5. India’s Central Pollution Control Board (CPCB) has released draft guidelines for the Pharmaceutical Industry in India, which are currently classified as highly polluting. The guidelines outline criteria for the establishment of pharmaceutical units, including mandatory minimum distances from sensitive areas. Stakeholders and the public are invited to submit their comments and suggestions on the draft guidelines by February 5, 2025.
Source: bit.ly/4h1GC0Y

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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 (FSSAI), in its 45th meeting, decided that the amendment to the Food Safety and Standards (Labelling and Display) Regulations, 2020, will be enforceable from 1st July 2025. This is subject to the condition that at least 180 days have passed from the date of notification of the amendment. Additionally, in cases of emergency, a separate decision may be taken regarding enforcement.
Source: bit.ly/3BPK9jH

2. The Supreme Court of India recently ruled that while courts have the authority to order the seizure of vehicles pending trial under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act), there is no provision in the Act that prohibits the return of seized vehicles. The Court emphasized that owners of such vehicles should be given an opportunity to be heard regarding the restoration of possession, particularly if they had no knowledge of the transport of narcotic or psychotropic substances,
Source: bit.ly/3DNibWg

3. The Rajasthan High Court, in a matter seeking to quash a petition against pathologists at a hospital accused of falsifying reports based on signature irregularities, held that cases of medical negligence must be subjected to a higher degree of scrutiny. The court further stated that mere irregularities in documents do not constitute falsification.
Source: bit.ly/3C2O64y

4. India’s Directorate General of Foreign Trade (DGFT) has issued a public notice regarding procedure for exporting certified organic products from the country. The new procedure requires that all ‘organic products’ intended for export should carry a Transaction Certificate issued by a National Accredited Body under the National Program for Organic Production (NPOP) and should be labelled in accordance with the NPOP. A revised NPOP will come into force from 5th July 2025
Source: bit.ly/4j48uD1

5. The US Food and Drug Administration has issued a finalized guidelines under the Advanced Manufacturing Technologies Designation Program, whereby manufacturers are able to obtain designation of the manufacturing process which may either reduce development time of drug or maintain supply of life-supporting, life-sustaining or critical drug.
Source: bit.ly/4j3H3Jr