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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. CDSCO has proposed a draft list to revise the existing classification list of cardiovascular and neurological devices, categorizing 351 cardiovascular and 202 neurological devices under a risk-based classification. Stakeholders can review and submit feedback within 30 days via a Google Form before finalization.
Source: bit.ly/3QYf29q

2. The central government has no plans to set up a special tribunal for medical negligence cases. Instead, such cases are handled by State Medical Councils, which can take disciplinary action against doctors. Appeals can be made to the National Medical Commission (NMC).
Source: bit.ly/42jt9LX

3. The 2025 National Trade Estimate Report states that unclear licensing guidelines and import procedures under India’s Medical Device Rules have delayed U.S. exports of refurbished medical devices. Since April 2024, CDSCO has suspended approvals for existing and new import licenses, effectively blocking refurbished medical device imports.
Source: bit.ly/4lfgp1s
Source: bit.ly/41W3pWY

4. The Central Consumer Protection Authority fined three lotion companies for falsely claiming in e-commerce ads that their products whiten skin instantly. The Bureau of Indian Standards found no scientific proof. The companies removed their ads and were warned of a ₹50 lakh fine for repeat violations.
Source: bit.ly/3G2pB94

5. India’s Delhi High Court upheld Consumer Protection Authority guidelines barring automatic service charges addition in restaurant bills. It was further held that collecting such service charge under other names constitutes an unfair trade practice. Additionally, GST cannot be charged on service charges.
Source: bit.ly/4j88ukG

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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 Council of Medical Research-led national health consortium raises concern over rising adolescent obesity and recommends stricter advertising rules on high-fat, -salt, and -sugar (HFSS) foods. It also proposes a 32% health tax on sugar-sweetened beverages and 20-30% tax on other HFSS foods to curb obesity.
Source: bit.ly/42dvtUq

2. The Organization of Pharmaceutical Producers of India has raised concerns with the health ministry as foreign drugmakers face delays in launching essential drugs. Despite a provision for waivers on clinical trials for drugs approved in select countries, the Drug Controller General of India has not approved any.
Source: bit.ly/3RtXxhr

3. India’s National Centre for Disease Control (NCDC), operating under the Ministry of Health and Family Welfare (MoHFW), is reportedly preparing to launch a new digital portal designed to provide real-time tracking of rabies vaccine and anti-snake venom stocks. which are not easily accessible owing to manufacturing shortage. The portal will initially be rolled out as a pilot project in five states: Andhra Pradesh, Assam, Madhya Pradesh, Delhi, and Puducherry.
Source: bit.ly/3R186bH

4. The State Consumer Disputes Redressal Commission (SDRC) of Chandigarh, India has set aside an order against a plastic surgeon for medical negligence allegation for unsatisfactory results under a liposuction procedure. SDRC ruled that unsuccessful treatment does not amount to negligence unless there is clear proof of deviation from clinical standards.
Source: bit.ly/4hTidKv

5. Reimbursements to private hospitals under the Central Government Health Scheme (CGHS) reportedly increased significantly from 24% in 2019-20 to 60% in 2023-24, driven by a rise in beneficiaries. This surge has raised concerns about fraudulent billing, overcharging, and inadequate oversight of spending.
Source: bit.ly/4jdwjYn

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 District Consumer Court in Jaipur has issued legal notices to certain Indian film actors for making misleading claims in a pan masala advertisement and misrepresenting the product. The petition seeks action against the actors for misleading consumers with false claims.
Source: bit.ly/3XH8gbQ

2. India’s top music labels have filed a suit against an AI company on grounds that AI Company has used copyrighted music and sound recordings to train its AI models without authorization. The outcome of the suit will bring clarity on the legality of use of copyrighted material by AI companies to train AI.
Source: bit.ly/4ilUqnz

3. Indian rubber glove manufacturers have raised concerns over the import and stockpiling of low-quality, non-medical gloves by importers in anticipation of potential notification of Medical and Surgical Gloves (Quality Control) Order (QCO). After QCO, only BIS certified gloves for medical use will be permitted to be sold in India.
Source: bit.ly/3Dna2YV

4. The former CEO of a leading U.S. diagnostic company has reportedly pleaded guilty to charges over defective lead-testing devices that posed a public health risk. The company had failed to inform US Food and Drug Administration about inability of its product to meet the claims made on the label and was prosecuted for marketing misbranded products.
Source: bit.ly/41Dod3X

5. India’s National Pharmaceutical Pricing Authority (NPPA) will reportedly consider additional data sources, including IPDMS, web sources, and market surveys, to set ceiling prices for scheduled formulations. This decision comes in wake of concerns about the limited coverage of Pharmatrac, particularly regarding hospital supply products.
Source: bit.ly/41Doh3H

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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 Ministry of Environment, Forest and Climate Change has clarified the manner of labelling on battery, battery pack or equipment having battery or battery pack by notifying an amendment to the labelling requirements prescribed under the Battery Waste Management Rules, 2022. Now, labelling declarations can be made through QR Code or product information brochure.
Source: bit.ly/3XgF3Vc

2. Indian Government has reinforced its requirement for the electronic issuance of Certificates of Origin (CoO), cautioning exporters and agencies against using manually issued certificates. The Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce and Industry, has issued a Trade Notice reminding all stakeholders that any CoO issued outside the online eCoO 2.0 platform will be deemed to be invalid after the specified deadlines.
Source: bit.ly/43aT6PC
Source: bit.ly/3XjttZn

3. India’s Karnataka Government has requested the Union Health Ministry to implement a system for sharing alerts about drugs that fail quality tests. This initiative aims to tackle the issue of substandard injectable drugs that do not pass sterility tests.
Source: bit.ly/43dDjji

4. India’s Health Ministry has reportedly revoked the export NOCs and manufacturing licenses for exporting unapproved Tapentadol and Carisoprodol combination drugs to West Africa. Both drugs are individually approved in India, but their combination is not. Reportedly a shipment to Ghana is also under investigation.
Source: bit.ly/4hXNxc8

5. India’s Supreme Court has recently emphasized the need for establishing a mechanism to address complaints related to misleading medical advertisements and called for strict action to curb such deceptive ads. The Court also highlighted the importance of consumer protection and ensuring that advertisements in the medical field do not mislead.
Source: bit.ly/3D7kVxG

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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 Supreme Court of India by dismissing a review petition held that doctors and medical professionals rendering paid services will fall under the Consumer Protection Act 1986.
Source: bit.ly/3EJukMp

2. The Department of Telecommunications (DoT) has directed social media and application hosting platforms to remove content enabling Caller ID spoofing, citing violations of the Telecommunications Act, 2023. The advisory warns that tampering with telecom identifiers is a cognizable and non-bailable offence, and platforms failing to comply may face legal action.
Source: bit.ly/4k8UNDu

3. The Indian Pharmaceutical Association (IPA) has raised serious concerns over the National Pharmaceutical Pricing Authority (NPPA) mandate for all offline and online pharmacies to display current drug prices on their websites to protect consumers from overpaying as impractical and unfeasible.
Source: bit.ly/4k3GEY3

4. The WHO’s 2025 update to the International Classification of Diseases (ICD-11) introduces a new module for traditional medicine, recognizing Ayurveda, Siddha, and Unani systems alongside conventional healthcare. This move strengthens their role in global health reporting, research, and policymaking, fostering integrative healthcare.
Source: bit.ly/4kagsv4

5. The Food Safety and Standards Authority of India (FSSAI) has proposed a draft amendment to the Food Safety and Standards (Labelling and Display) Regulations, 2020. Key changes include mandatory bold labeling of added sugar, saturated fat, and sodium content, a compulsory logo as provided on all milk and milk products, and clearer front-of-pack declarations for coffee-chicory mixtures. Public objections or suggestions can be submitted within 60 days from the date issuance of notification.
Source: bit.ly/40Zx4ws

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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. All insurance and healthcare policies are by law required to accommodate mental healthcare treatment under the Mental Healthcare Act, 2017. Therefore, even if an explicit provision exists in a current policy, it cannot be ground to refuse reimbursement for mental healthcare services availed under the policy: High Court.
Source: bit.ly/3Qm1LHg

2. The District Consumer Disputes Redressal Forum in Gujarat has recently held that insurance providers cannot rely on a discrepancy in documentation to deny a claim for treatment, provided that the justification letter of the treating doctor sufficiently addresses the eligibility of a claimant under the policy.
Source: bit.ly/41ivGqj

3. The National Human Rights Commission (NHRC) has recently held a core-group meeting to recognize the impact of progressive disabilities and possible changes in applicable law to address the same. The NHRC has also proposed to re-visit the current 40% benchmark for disabilities, to accommodate cases of persons with progressive disabilities.
Source: bit.ly/4hEfMwb

4. A Consumer technology product manufacturer has recently won its invalidation petition before a Federal Court of the United States, with this, the complainant in this matter now has complete and undisputed Intellectual Property rights in the US, over the underlying technology for detecting heart-rate in wearables.
Source: bit.ly/432ybye

5. The World Health Organization released new findings highlighting a concerning lack of awareness about alcohol’s link to cancer in Europe. It called for clear, prominent tobacco-style warnings, particularly in the region with the highest alcohol consumption. While the WHO has consistently warned about alcohol’s cancer risk and supported labeling, this is the first time it has directly called for new government regulations.
Source: bit.ly/4102Vxj

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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 Regulator has notified that the application process for issuance of permission for import of additional variant of approved cosmetics into the country, will henceforth be conducted through additional module which will be activated on the SUGAM portal from the 22nd February 2025.
Source: bit.ly/3CQu6m2

2. The National Chemists’ Association has sought a meeting with India’s drug price regulator the National Pharmaceutical Pricing Authority (NPPA) to highlight concerns that the obligation on chemists to publicly display the prices of all drugs being sold, may be a very heavy burden for the industry.
Source: bit.ly/3QfYFor

3. The Pune Municipal Corporation (PMC) has issued show-cause notices to 97 private nursing homes and hospitals for violations of the Bombay Nursing Home Registration Act and Maharashtra Nursing Home Registration Rules. Key breaches include non-compliance with fire safety regulations, lack of patient complaint mechanisms, inadequate staffing, and failure to meet other legal standards like displaying contact information and maintaining proper treatment tariffs.
Source: bit.ly/41bya9P

4. In a recently published guideline, the United States Food and Drug Administration has expanded the applicability of Predetermined Change Control Plans (PCCPs) scheme, now requiring manufacturers to notify any post-market changes made to devices, which operate using Artificial Intelligence and not just those devices that use Machine Learning.
Source: bit.ly/4aZ3D2i

5. A Federal Court in the United States has recently dismissed the petition of a prominent drug manufacturer claiming “unfair business practices” by a pharmacy selling compounded versions of a patented drug, on the ground that the pharmacy has ceased to market and sell the compounded version of the drug.
Source: bit.ly/4aYtVSa

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 advertising self-regulation body, the Advertising Standards Council of India (ASCI), has issued a report analyzing the conduct of the country’s leading online influencers. Notably, the report reveals that only 29% of the influencers have even made appropriate disclosures of material connection with brands/companies their content.
Source: bit.ly/4k649jp
Source: bit.ly/40NSywt

2. In pursuance of the Central government’s BioE3 policy, which was announced in November 2024, the Central Government Minister for Science and Technology has urged State Governments to set up BioE3 Cells to promote Center-state partnership in pursuance of the BioE3 policy aims.
Source: bit.ly/4jTZjW4
Source: bit.ly/40UBchz

3. India’s Health Ministry has reportedly established an expert working group that will monitor adverse effects of medical devices and IVDs which are reported under Materiovigilance Programme of India (MvPI), and will recommend measures to improve patient safety to Indian’s medical device regulator, the Central Drugs Standards Control Organization (CDSCO).
Source: bit.ly/3ExgA7l

4. Earlier this year, The United States Food and Drug Administration has issued a proposed new rule which would have introduced a cap on the nicotine content in cigarettes and other tobacco products, in an effort to curb deaths from nicotine addiction in the country.
Source: bit.ly/3WVFdRr

5. In cases of insurance claim of medical treatment costs for chronic illness, insurance providers cannot deny a claim on technical ground of absence of in-patient treatment, if the treating Doctor had determined outpatient treatment was sufficient for the patient: High Court
Source: bit.ly/3CWwSpM

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 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

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 Parliamentary Standing Committee on Ministry of Chemicals and Fertilizers has made a recommendation to the country’s drug price regulation authority (the National Pharmaceutical Pricing Authority), to install and implement the Price Monitoring and Resource Units in all of States and Union Territories where they have not yet been set-up.
Source: bit.ly/4hBFqB8

2. The State Consumer Redressal Commission of the state of Delhi recently held that the obligation of a treating doctor to attend to a patient during an emergency situation, should supersede and mitigate his liability against any claim of negligence that may be levelled against him for his failure to refer the patient to a concerned specialist where such specialized treatment may be deemed necessary but for the emergency situation.
Source: bit.ly/4jAMHTG

3. India’s foreign trade regulator, the Directorate General of Foreign Trade has issued a Notification instructing Regional Authorities (Ras) to reduce the Export Obligations of exporters in sectors that have experienced a decline of more than 5% in volume. This now includes, among other product categories the export of Radioactive Isotopes from India.
Source: bit.ly/42zKAcB

4. India’s foreign trade regulator, the Directorate General of Foreign Trade has altered the procedure for obtaining a Certificate of Origin (CoO) by exporters. Notably, the Export Inspection Council (EIC) has been stripped of its previous authority to provide and print blank CoOs, and applicants will also now be required to make their applications on the online platform.
Source: bit.ly/4hALDxj
Source: bit.ly/3EpEjGm

5. The Parliamentary Standing Committee on Ministry of Chemicals and Fertilisers has recommended in its recent report, that various State Licensing Authorities should be sensitized on the best practices and procedures for the issue of license for Class A & B Medical Devices.
Source: bit.ly/4az0Lch