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

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

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 classified packaged drinking water as a high-risk category, mandating pre-licence inspections of packaging facilities and annual risk-based audits for existing licence holders. This move aims to ensure hygiene and quality standards, aligning bottled water regulation with stricter public health norms.
Source: short-link.me/17nQx

2. Big private hospitals in India are opposing the General Insurance Council’s common empanelment proposal, arguing it lacks clarity on tariffs, timely claim settlements, and dispute resolution for short payments. They demand wider consultation and revisions before acceptance, stressing the framework must address operational challenges while ensuring insurers’ goal of streamlined empanelment and policyholder access.
Source: short-link.me/1bQ13

3. The GST Group of Ministers (GoM) has reportedly proposed eliminating the current 18% GST on individual life and health insurance premiums. The constituted panel will present recommendations by October 2025 and the final will be taken by GST Council.
Source: short-link.me/17nQT

4. The Pharmaceuticals Export Promotion Council of India is reportedly collaborating with stakeholders to launch an online logistics platform to integrate exporters, importers, service providers, and regulators. The tool aims to centralise compliance, bidding, warehousing, insurance, routing, digital documentation, tracking and feedback.
Source: short-link.me/1bQ1l

5. India’s central drug regulator has recently mandated that exported drugs must retain at least 60% of their shelf life, prompting pharmaceutical companies to discard older inventory and incur significant financial losses. Industry stakeholders caution that the rule introduces substantial economic and logistical strain without offering adequate flexibility.
Source: short-link.me/1bQ1u

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 Madras High Court has refused to pass interim order staying the controversial gaming law in Tamil Nadu, which prohibits minors under 18 years from playing games and generally imposes restrictions on gaming between 12 am and 5 pm.
Source: bit.ly/43hwJYX

2. Andhra Pradesh’s Director of Medical Education has instructed government medical colleges and hospitals to ensure doctors prescribe drugs using generic names. The ethical guidelines applicable to doctors mandate prescription in generic names, and brand name may be used in addition.
Source: bit.ly/43nG6WS

3. India’s Department of Pharmaceuticals (DoP) has established a technical committee to devise strategies aimed at enhancing supply chain resilience and reducing reliance on China for pharmaceutical products. This initiative, part of the Indo-Pacific Economic Framework, aims to strengthen key industries like healthcare and chemicals.
Source: bit.ly/43aZ1UZ

4. India’s Central Food Regulator (FSSAI) will reportedly release new Maximum Residue Level (MRL) values for 98 spices, up from the current values for 18 spices. A SOP guidance to fix MRL for pesticides is expected to be published soon as well.
Source: bit.ly/4h19LZl
Source: bit.ly/41luW2f

5. Delhi High Court has remarked that the government should put in place a legal framework to tackle “e-infringement” of trademarks in e-commerce. Since multiple parties are involved in e-commerce, it is difficult to determine who is responsible for infringement.
Source: bit.ly/4hX8TpY

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 level drug regulator the Central Drugs Standards Control Organization (CDSCO) has issued a correction to the list of Fixed Drug Combinations for which manufacturing licenses can be obtained directly from the state regulators. The updated list is available on the website of the CDSCO at the given link.
Source: bit.ly/4hnPvSI

2. India’s Nursing professional regulator, the Nursing Council of India has issued Regulations prescribing the institutional and educational standards required to conduct the Nurse Practitioner in Pediatric Nursing Program.
Source: bit.ly/40IkEsV

3. A district level Consumer Disputes Redressal Commission has recently held that insurance providers cannot deny claims of policy-holders, on grounds of a medical issue arising out of “pre-existing conditions” if the “pre-existing conditions” is not the sole cause of the medical condition for which claim as made.
Source: bit.ly/3Q7gbLs

4. India’s Ministry of Health and Family Welfare has recently notified the updated grievance redressal system, and new physical verification procedure for empanelled hospitals aimed at improving service offering under the government’s public healthcare scheme.
Source: bit.ly/3WMQbc7

5. Industry groups make a representation to the European Policymakers to withdraw its recent AI Public Liability Directive protocol which sought to introduce non-contractual civil liability rules to artificial intelligence used by service providers, claiming that the non-contractual nature of the civil liability will disrupt existing supply-chains based on contractual understanding between service providers and receivers.
Source: bit.ly/4hK9sTp
Source: bit.ly/4hKflzQ

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 Food regulator, the Food Safety Standards Authority of India, now requires linking of new licenses with the Permanent Account Number (PAN) of the applicants, additionally existing Food Business Operators have been requested to keep their PAN data up-to-date.
Source: bit.ly/48QImab

2. The Telangana Drugs Control Authority has issued notices to private hospitals in Hyderabad and Telangana, requiring stricter compliance with purchasing requirements for Narcotics Drugs, under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS).
Source: bit.ly/4hJQoWf

3.  The Ministry of Environment, Forest and Climate Change has relaxed penalties under the E-Waste Rules, 2022 and the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. From hereon, the contravention of any provision of these Rules shall not give rise to environmental compensation.
Source: bit.ly/4fqrp8W

4. In pursuance of an ongoing process for recovery of sums on account of a judgment of the Court for misleading conduct by the Respondent, the Supreme Court has issued an Order to auction the Trade Mark of a prominent Indian Hospital chain, while at the same time refusing to make provision for valuating the same.
Source: bit.ly/3Z1rcDf

5. European Union Drug Regulator considering proposal to reduce the duration of regulatory data protection available to companies.
Source: bit.ly/4hGEvQZ

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 Madras High Court has refused to impose a ban on advertisements by doctors and hospitals in the media, stating that it cannot expect media outlets to verify every advertisement on fake drugs, hospitals and treatments. The court acknowledged concerns about misleading advertisements and stated that doctors and hospitals should have self-regularisation and in case of violation the Medical Commission should take action.
Source: bit.ly/3CzfDu4
2. The Supreme Court of India raised serious concerns about live surgery broadcasts, citing risks to patient safety and informed consent. The court noted the absence of officials from the National Medical Commission and the Central Government during a hearing, emphasizing the need for guidelines to regulate such practices effectively.
Source: bit.ly/4fyc8CM3.

3. The Union Minister for Chemicals and Fertilizers, Jagat Prakash Nadda, has launched a new initiative called the “Scheme for Strengthening the Medical Device Industry,” to enhance manufacturing, skill development, clinical studies, and infrastructure in the medical device sector. It includes five sub-schemes designed to reduce import dependence and promote domestic production, ultimately supporting India’s goal of self-reliance in healthcare.
Source: bit.ly/4fjICRq

4. The Supreme Court of India has ordered the government to enforce mandatory accessibility rules under the Rights of Persons with Disabilities (RPWD) Act, 2016 emphasizing the need for compliance to ensure public spaces are accessible for disabled individuals. The court has given the government three months to establish clear guidelines and penalties for non-compliance.
Source: bit.ly/3UNULWl

5. Reportedly, government entities in India are exempt from the Digital Personal Data Protection (DPDP) Act, 2023, which permits them to process personal data under specific circumstances without following the Act’s normal provisions. Hospitals, however, are not granted this exemption and must therefore abide with data privacy regulations.
Source: bit.ly/3CkdRwZ

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 Drugs Consultative Committee (DCC) has reportedly recommended to make Sugam portal database of all the products with brand names accessible to the general public to address the issue of different drug formulations of different therapeutic categories being sold with same or similar brand names in the nation.
Source: bit.ly/3XMWBbV2. The National Accreditation Board for Hospitals & Healthcare Providers (NABH) has revised the accreditation standards for hospitals which will come into effect on January 1, 2025. No surveillance assessment will be conducted as per the old accreditation standard by NABH after 31st March 2025.
Source: bit.ly/47ydjPr

3. India’s Central Food Regulator will approve import of food consignments from Bhutan on the strength of Health Certificate issued by Bhutan Food and Drug Authority provided they are manufactured by the approved list of establishments of Bhutan.
Source: bit.ly/4gmtRxY

4. U.S. Food and Drug Administration has warned a major pharmaceutical company for making false and misleading claims about the benefits of a migraine pill in a television advertisement by a famous sports person. The claims were made against the results that were demonstrated in clinical trials.
Source: bit.ly/4gtau6m

5. A group of experts constituted by NITI Aayog to prepare a framework for action for emergency response and preparedness to address future pandemic, has recommended making the Central Drugs Standard Control Organisation (CDSCO) an independent regulatory authority. They have recommended to provide CDSCO with approved Standard Operating Procedures (SOPs) for Accelerated Emergency Use Authorisation for innovations and provisions for fast-tracking the process during pandemics.
Source: bit.ly/3XNynys

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Consumer Affairs Ministry’s is proposing to amend labelling and packaging regulations for pre-packaged goods. Currently, certain large packages, like those exceeding 25 kilograms or liters, are exempt from displaying crucial information. This includes details like the maximum retail price (MRP), the date by which the product should ideally be consumed (best before date), who manufactured it, and where it came from (country of origin). Other exempt categories include cement, fertilizer, agricultural produce in 50 kg bags, and products destined for industrial or institutional use. The proposed amendment aims to close this loophole and ensure all these bulk packages are labelled clearly and consistently, just like retail products.
The proposed amendments are open for public consultation till 29th July 2024.
Source: bit.ly/4cZPiCG

2. Maharashtra state in India has reportedly announced a ban on sale of energy drinks with high caffeine content within 500-meter radius of schools. This directive aims to safeguard student health.
Source: bit.ly/467rxGj

3. India’s Karnataka Medical Council (“KMC”) has issued a show cause notice to a dermatologist alleging violation of Code of Medical Ethics, 2002 for advertising drugs/medicines on social media. The action on the part of KMC comes after it received a complaint from Indian Association of Dermatologist, Venerologists and Leprologists.
Source: bit.ly/3zLuAYY

4. India’s drugmakers are pushing the government to loosen price controls. They propose exempting all medicines under ₹5 and extending the exemption for patented drugs (currently 5 years) to 10 years. This comes amid rising costs for ingredients, prompting them to request a reduction in GST on these materials. The industry argues stricter controls stifle research and development.
Source: bit.ly/3S7oqIF

5. Indian Supreme Court has rejected Doctor’s plea for improved security, which is filed by a Delhi Medical Association. The apex court was hearing the DMA’s petition which also sought directions to the authorities to ensure adequate security at hospitals and medical centres to prevent attacks on doctors and healthcare workers by patients’ relatives and others. The Apex Court stated that currently laws exist to deal with such instances.
Source: bit.ly/3Ln9Fh9

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

Corporate hospitals may soon have to comply with advertisement norms applicable to doctors

India’s National Medical Commission (NMC), which regulates the conduct of medical practitioners (doctors), has endorsed the position that all hospitals should comply with the same standards of ethics as are applicable to doctors under the NMC Registered Medical Practitioner (Professional Conduct) Regulations, 2023. The operation of 2023 Regulations is currently under suspension.
Source: bit.ly/3vpJ7aV

High Court imposes damages of 244 crores in Standard Essential Patents case

India’s Delhi High Court has reportedly imposed damages amounting to INR 244 Crores on an Indian smartphone manufacturer. The Court found smartphone manufacturer guilty of infringing seven patents on 2G, EDGE, and 3G technology granted to a global telecom company. The order is expected to be out soon.
Source: bit.ly/3TxOXyI

Drug Manufacturers will have to upload all product details on Government portal soon

The Drugs Consultative Committee (DCC), a committee comprising State-level Drug Regulators, has recommended that the Central Drugs Regulator, Central Drugs Standard Control Organization (CDSCO), should set a deadline for manufacturers of drugs to upload list of drugs manufactured on an online portal called SUGAM.
Source: bit.ly/3TxP0uo

Ban on trade of ferocious dog breeds has been stayed in various States in India

India’s Kerala High Court, Karnataka High Court and Kolkata High Court has stayed a controversial circular of the Central Government which prohibited import, trading and selling of 23 breeds of dogs identified as ferocious in the circular. The circular also mandated sterilization of dogs from further breeding as pets. The circular has been challenged on the ground that it is unscientific, not based on evidence and has been issued without consultation with relevant stakeholders.
Source: bit.ly/3TVZcyi

European Medicines Agency urges sponsors of clinical trials to register on new portal before January 2025 deadline

The European Medicines Agency (EMA) has strongly advised sponsors of clinical trials that have been approved before 31 January 2023 to submit application to move the clinical trials to the new Clinical Trials Information System (CTIS) as soon as possible, considering it will take EMA up to three months to review and authorize the application. As of now, only 20% of clinical trials have been moved to the new platform.
Source: bit.ly/3TZRzHl