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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 Allahabad High Court recently ruled that insurance payouts must follow succession laws. It clarified that a nominee is not the actual heir but only holds the money on behalf of the legal heirs. So, the nominee cannot keep the insurance amount for themselves if there are rightful successors.
Source: bit.ly/4jMr2Yu

2. The Indian government has issued a Quality Control Order (QCO) mandating that all aluminum and aluminum alloy foil used for pharmaceutical packaging, along with other specified aluminum and aluminum alloy products to bear the Standard Mark under a license from the Bureau of Indian Standards. The order will take effect on 1st October 2025 and does not apply to products manufactured in India for export purposes.
Source:  bit.ly/3Sno9B4

3. India’s National Pharmaceutical Pricing Authority (NPPA) has fixed separate retail prices for new drug formulations manufactured by a pharmaceutical company. The company requested the separate pricing by highlighting the unique features of packaging like self-collapsibility and self-seal ability, not having air-vent and no chance of contamination during manufacture/ infusion/ admixing levels.
Source: bit.ly/4k7f3nR

4. The Government of India is reportedly planning to invoke the Essential Services Maintenance Act (ESMA) to prevent hoarding and ensure uninterrupted access to essential commodities. This move comes in response to potential supply chain disruptions and as part of anti-profiteering measures following Operation Sindoor.
Source: bit.ly/3GKcXvV

5. The United States government has issued an executive order aimed at boosting domestic pharmaceutical manufacturing. The order directs the Food and Drug Administration (FDA) to expedite the approval process for new domestic production facilities. Additionally, the government plans to impose tariffs on pharmaceutical imports to encourage domestic production and reduce reliance on foreign suppliers.
Source: bit.ly/3EVqyA8

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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 declined to grant an interim injunction against four influencers who criticized a popular protein brand’s product in YouTube videos. The Court ruled that their comments, based on lab reports, constituted fair comment in public interest and not defamation.
Source: bit.ly/3GxgRIw

2. The Supreme Court of India has ruled that the limitation period for filing appeals under the Commercial Courts Act, 2015, begins from the date the judgment is pronounced, not when the party receives the judgment copy. The Court held that delay in seeking a certified copy doesn’t justify condoning limitation period.
Source: bit.ly/432T5fc

3. An Indian District Consumer Disputes Redressal Commission has ruled against an insurance company for unfair trade practices after it denied a valid accident claim. The complainant signed the discharge voucher but added the words “with protest” to express his disagreement, which led to its denial.
Source: bit.ly/4jtaZi1

4. India’s Department of Pharmaceuticals (DoP) has reportedly requested export data from Pharmexcil, under the Ministry of Commerce and Industry, amid ongoing trade restrictions with Pakistan. The move is aimed at assessing the flow of pharmaceutical products between the two countries.
Source: bit.ly/42Osz96

5. Swissmedic has invited feedback on the International Council for Harmonisation (ICH) Guideline M13B, which aims to harmonize bioequivalence study designs and data analysis methods for immediate-release solid oral dosage forms like tablets, capsules, and granules/powders for oral suspension. Stakeholders may submit feedback until July 9, 2025.
Source: bit.ly/44bvFq2

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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 inspectors from Bureau of Indian Standards found illegal stock of consumer products at warehouses of e-commerce companies. The consumer products required BIS license to be placed on market for sale but did not carry them. E-commerce entities are required to exercise due diligence prior to stocking and listing items for sale, or face liability
Source: bit.ly/428WxW2

2. India’s Bombay High Court has ruled that an arbitration clause in invoices can be binding if the parties act on the invoices and do not raise objections. The court held that by accepting and paying the invoices, the parties implicitly agreed to the arbitration clause, making it enforceable.
Source: bit.ly/4ibuivJ

3. The Parliamentary Standing Committee on Health and Family Welfare has recommended creating a single independent drug controller for AYUSH medicines, uniform licensing processes across states and strengthening of pharmacovigilance. It also urged stricter action against misleading advertisements and improving drug safety and quality.
Source: bit.ly/3DxmFRi

4. India’s Parliamentary Standing Committee on Health has highlighted delays and lack of transparency in medical device licensing by CDSCO, pushing medical device companies to shift manufacturing abroad.
The Committee has recommended a streamlined, digitized system, faster approvals for internationally certified products, and the establishment of an advisory board to address regulatory challenges in the industry.
Source:  bit.ly/41pF6PC

5. The Insurance Regulator is reportedly gearing up for passage of The Insurance Amendment Bill 2024. Key features of the bill aim to enhance operational flexibility and attract more investment into the insurance industry by allowing 100% foreign direct investment (FDI) and by allowing insurance companies to merge with non-insurance entities for strategic partnerships and increased synergies.
Source: bit.ly/4iaOLRk

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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 medical device company has received compensation calculated at 25% of sales generated by a counterfeiting entity. The Court opined that 25% was a conservative profit margin for awarding damages. The Court has additionally awarded exemplary damages to punish the counterfeiting entity.
Source: bit.ly/4kHWYhn

2. The Indian Pharmaceutical Alliance (IPA) has reportedly questioned the authenticity of an US study linking India-made generic medicines to higher rates of serious adverse events (SAEs) calling the claims unfounded. IPA highlighted that Indian manufacturing facilities undergo stringent inspections by regulators like the FDA, and lower costs are due to production efficiencies, not compromised quality.
Source: bit.ly/4kEqkx8

3. The Indian government is reportedly considering exemption of health and life insurance premiums from the current 18% GST. The GST Council has sought input from the Insurance Regulatory and Development Authority of India (IRDAI), with the industry advocating for a reduction to 12% instead of a complete exemption or lower rate (5%), to be able to claim Input Tax Credit (ITC) on taxes paid for business operations.
Source: bit.ly/3Fu3dFx

4. India’s Health Ministry has reportedly directed the Drug Controller General of India (DCGI) to focusing on eliminating poor-quality medicines, supporting small pharma manufacturers (MSMEs), and refining medical device regulations. The move is aimed at enhancing global trust in Indian medical products and exports.
Source: bit.ly/3DHeK3J

5. The Director General of Foreign Trade (DGFT) has invited comments on proposed changes to export policy for Special Chemicals, Organisms, Materials, Equipment and Technologies (SCOMET), which seek to fast-track grant of approval. SCOMET goods typically face strict export controls.
Source: bit.ly/3Fr2Uva

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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 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. India’s Directorate General of Foreign Trade (DGFT) has launched an online module for filing the Annual Remission of Duties and Taxes on Exported Products (RoDTEP) Return (ARR), aimed at streamlining the process for pharma exporters. The module is available on the DGFT Portal and simplifies ARR filing, eliminating the need for physical documents.
Source: bit.ly/4hxQShu

2. India’s Parliamentary Standing Committee on Chemicals and Fertilisers has urged the Centre to actively implement recommendations from the Standing Forum on Medical Device Association, focusing on streamlining logistics and transitioning to licensing all types of medical devices.
Source: bit.ly/40XAnp8

3. The Directorate General of Foreign Trade (DGFT) has withdrawn the Track and Trace System for pharmaceutical exports under the Foreign Trade Policy (FTP), which required barcoding on primary packaging. The withdrawal is attributed to the implementation of the Ministry of Health & Family Welfare’s (MoH&FW) own barcode/QR code system, along with the fact that most export destinations have their own traceability systems.
Source: bit.ly/4aQDzqc

4. India’s Finance Minister has announced that 36 life-saving drugs, including cancer treatments, will be exempted from basic customs duty. Additionally, 37 more medicines will also benefit from this exemption. Furthermore, 6 life-saving medicines will be added to a list with a concessional 5% customs duty. The GST rate on cancer drugs like Trastuzumab, Osimertinib, and Durvalumab has been reduced from 12% to 5%. A new 13 Patient Assistance Programme has also been introduced.
Source: bit.ly/40UODPz

5. India’s Finance Minister in its 2025-26 Union Budget, announced that gig workers will be included in the Pradhan Mantri Jan Arogya Yojana (PMJAY) health insurance scheme. This will provide healthcare coverage to nearly 10 million online platform workers, offering financial protection to a sector that previously lacked structured benefits.
Source: bit.ly/4gmQwsN

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 Bombay High Court’s Division Bench has stayed an order penalizing a leading AYUSH drug manufacturer for violation of an injunction order on the selling of camphor products thereby infringing another company’s organics’ trademark. Earlier the drug manufacturing company was imposed with a penalty for contempt of court after observing continued violations of the restraining order since 2023.
Source: bit.ly/3ZF02RK

2. India’s Delhi High Court has directed online platforms, including Telegram, to block accounts linked to an anonymous user threatening to leak an insurance company’s confidential customer data. The court emphasized that misuse of such data could lead to identity theft, fraud, and privacy violations and restrained the unidentified entity from sharing the data and ordered intermediaries to disclose its details.
Source: bit.ly/3VKUjbT

3. India’s Karnataka government has reportedly merged the Department of Food Safety and Standards with the Drug Control Department, renaming it as the Food Safety and Drug Administration (FDA). The move aims to streamline operations and enhance service delivery under a unified Commissioner. Officers and staff will now function under the FDA’s administrative control, with steps being taken to restructure rules and regulations. The decision follows similar mergers in states like Maharashtra, Gujarat, and Tamil Nadu.
Source: bit.ly/4flpL7B

4. The Union Ministry of AYUSH (MOA) will reportedly launch a national portal, ‘Trinetra’, for pharmacovigilance in Indian Systems of Medicine (ISM) to curb misleading advertisements. Announced at the World Ayurveda Congress in Dehradun, the portal will ensure quicker reporting of misleading advertisements thereby improving consumer safety. Experts emphasized the need to protect Ayurveda’s reputation and address false claims of “magic cures” and “side-effect-free” treatments.
Source: bit.ly/4gC7y6O

5. India’s Supreme Court has criticized the Delhi government for failing to provide data on daily solid waste generation, calling it a “shocking state of affairs.” Despite an order dated November 18, 2024, the data remains pending, prompting the Court to warn of contempt proceedings if an affidavit is not submitted by December 18, 2024. The Chief Secretary has been directed to appear before the Court on December 19. The Court expressed concern over untreated solid waste, linking it to public health risks and landfill fires.
Source: bit.ly/3ZZyXtK

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 Food regulator, the Food Safety and Standards Authority of India (FSSAI) has issued a advisory to e-commerce Food Business Operators (FBOs) to ensure that: (1) Last-mile delivery systems are made more robust, and persons handling last-mile delivery are given suitable training to handle the food items, and (2) The e-commerce FBOs are compliant with the labelling requirements as specified in relevant regulations, keeping the listings on the website consistent with content of actual food label.
Source: bit.ly/4f0zEaA

2. India’s Ministry of Finance has published an Office Memorandum seeking public comment up to the 10th of December, on certain amendments to the prevailing insurance regulations in the country. These proposed amendments include among other things, permitting a 100% Foreign Direct Investment in the insurance sector through the automatic-route, and permitting insurers to undertake offer of more than one class of insurance.
Source: bit.ly/4ifYwxT

3. India’s Central Ministry of Consumer Affairs is reportedly developing an online portal to handle the licensing, verification and stamping of weighing and measurement instruments as well as to provide a source of information on verified trade instruments for consumers.
Source: bit.ly/41km5Q6

4. The High Court of the States of Punjab and Haryana held that outside of introduction of evidence to the effect, the mere failure of a medical surgery/ procedure would itself not be sufficient to establish medical negligence claims, especially if the patient had been appropriately sensitized of the risks involved.
Source: bit.ly/49nlkrJ

5. In its finalized version of the regulations regarding Pre-determined Change Control Plans, the US Food and Drug Administration has plainly classified Artificial Intelligence (AI) as a sub-set of Machine Learning softwares when it comes to regulation of Medical Devices, and further makes it mandatory that in making submissions the version of the device software need to be submitted with the FDA to ensure version control.
Source: bit.ly/4imQQu2