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 Punjab & Haryana High Court mandates state government to notify rules under Mental Healthcare Act, 2017 within 60 days, addressing a 7-year delay that hampers effective implementation and delivery of mental health services.
Source: bit.ly/4k3CEpU

2. India’s Central Drugs Standard Control Organisation (CDSCO) has issued a guidance document outlining the procedure for obtaining a Free Sale Certificate (FSC) for licensed medical devices in India. It simplifies the regulatory process for submitting an application and obtaining the FSC from the Central Licensing Authority.
Source: bit.ly/3FbKQW9

3. Food Safety and Standards Authority of India (FSSAI) mandates that FBOs with expired licenses or registrations in FY 2024–2025 must submit a Closure Report via the FoSCoS portal. The report must confirm no ongoing business or provide details of a new license. Reasons for non-renewal must be stated to ensure transparency and traceability in licensing.
Source: bit.ly/3Se67kQ

4. India’s Department for Promotion of Industry and Internal Trade (DPIIT) has extended the implementation of the Quality Control Order (QCO) for household and commercial electrical appliances to March 19, 2026. The update includes relaxations for Micro, Small and Medium Enterprises, R&D and export units, supporting quality and ease of business.
Source: bit.ly/4ksMTEb

5. The Drugs Control Department of Kerala has taken an action against a private hospital for illegally stocking and selling Physician’s sample medicines at inflated prices, highlighting that sample medicines can neither be stocked nor sold by hospitals.
Source: bit.ly/3FieSaJ

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 The Indian Supreme Court has ruled that individuals convicted of food adulteration offences under the now-repealed Prevention of Food Adulteration Act cannot be granted probation. The Court clarified that the law in force at the time mandated strict punishment for such offences, and the bar on probation remains valid under the current Food Safety and Standards Act, 2006.
Source: bit.ly/3SD2x3R

2. India’s Chhattisgarh High Court has invalidated tender clauses by the Chhattisgarh Medical Services Corporation Limited that permanently barred previously blacklisted companies from bidding, even after their blacklisting period had ended. The Court emphasized that such conditions are arbitrary and violate principles of fairness in public procurement.
Source: bit.ly/45aP0Ik

3. India’s Jharkhand High Court ruled that selling goods at concessional rates alone does not amount to a sham transaction. The Court quashed notices issued for alleged discrepancies, stating that comparing sale prices to market rates is not sufficient grounds to question the authenticity of the transactions.
Source: bit.ly/4kfrgqE

4. The Indian government has invited fresh applications under the Performance-Linked Incentive (PLI) scheme to boost domestic production of bulk drugs. The focus is on 11 key product categories, including Active Pharmaceutical Ingredients (APIs), Key Starting Materials (KSMs), and intermediates. The initiative aims to reduce reliance on imports, particularly from China.
Source: bit.ly/42Zm6ti

5. A leading beverage company will revise its recycling labels following a greenwashing complaint by the European Consumer Organisation (BEUC). The updated labels will clarify that only the bottle body contains 100% recycled plastic, exclude caps and labels, and remove green imagery and the phrase “Recycle Me Again” to avoid misleading consumer.
Source: bit.ly/4khtF4V

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 Supreme Court has ruled that volume-based discounts are lawful and do not constitute discriminatory pricing, for such discounts to be considered discriminatory they must be applied unequally to similarly situated buyers in comparable transactions.
Source: bit.ly/4mghWEN

2. India’s Supreme Court has issued a notice to the central government on a petition seeking to make it mandatory for hospitals and clinical establishments to display service rates and charge fees within limits set by the Centre, in consultation with state governments. The Court noted that the failure to enforce this requirement stems from the government’s failure to specify the service charge limits which potentially impacts citizens’ fundamental right to healthcare.
Source: bit.ly/4jXJ75U

3. The High Court of Jammu & Kashmir and Ladakh has upheld a government advisory requiring retail and wholesale pharmacies to install CCTV cameras and adopt computerized billing systems. This measure aims to curb the sale of prohibited drugs and enhance transparency in pharmaceutical operations.
Source: bit.ly/4mgjrCV

4. In a proposed Free Trade Agreement with the UK, India has reportedly decided to reduce import duties on medical devices under the Production-Linked Incentive (PLI) scheme starting only from the sixth year. This phased approach aligns consumer needs with the Make in India programme, aiming to protect domestic manufacturers while gradually opening market access for UK exporters.
Source: bit.ly/4mlyPy8

5. The U.S. government’s order to align domestic drug prices with global rates may impact Indian pharmaceutical firms, many of which rely heavily on U.S. revenues. Though primarily targeting Big Pharma, the move could subject Indian generic manufacturers to pricing pressure, potentially disrupting their business models and profitability.
Source: bit.ly/4dkH0Xt

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 issued guidance for obtaining NOCs to manufacture for export of approved/unapproved new drugs. It sets a 7-day timeline for NOC issuance, allows limited reuse of un-exported stock within specified residual shelf lives, and mandates quantity-specific NOCs for NDPS/banned drugs.
Source: bit.ly/4iQ5g4z

2. India’s Bombay High Court has issued notice to central drug regulator CDSCO’s response to a petition filed by a cancer research organization for rejection to initiate Phase I human trials of its homegrown cancer immunotherapy vaccine which has not been tested on animals.
Source: bit.ly/3ESEcUD

3. Patient groups, health organizations and patent experts in India have reportedly urged the Indian government to oppose TRIPS-plus provisions in Free Trade Agreements (FTA) with the US, UK, and EU, citing risks to affordable medicine access and self reliant domestic pharma industry.
Source: bit.ly/3EYEFEG

4. A Recent vaccine trial faced criticism after children were offered financial incentives to participate, raising ethical concerns. The promotional material, shared via messaging apps, was based on unapproved drafts. The UK’s Prescription Medicines Code of Practice Authority (PMCPA) found that ethical standards were not upheld, and no internal investigation was conducted by the sponsor.
Source: bit.ly/4iTpxGq

5. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has reportedly launched a strategic AI roadmap to enhance regulatory efficiency, data analysis, and decision-making, aligning with the EU AI Act and fostering innovation in pharmaceutical regulation.
Source: bit.ly/454woJZ

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

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) has proposed halting new registrations and the renewal of existing registrations for the manufacturing of certain high-risk foods, such as dairy products and infant nutrition. They have also proposed permitting only state or central licenses and implementing pre-license inspections for manufacturers in these categories. They have sought public feedback on these proposed changes by 30th May, 2025.
Source: bit.ly/3RRy4Po

2. The Bombay High Court directed the state government to consider a separate registration facility for patients who are not yet on dialysis but will soon need an organ transplant. This came after a CKD Stage-V patient was denied registration. The Court said such denial violates the right to life.
Source: bit.ly/3RM4xqh

3. India’s ministry of commerce and industry has prohibited the use of specified antibiotics, antivirals, and antimicrobial medicinal products in fish, shrimp, hatchery operations or any manufacturing, pre-processing and processing unit to prevent antimicrobial resistance and safeguard export quality.
Source: bit.ly/44ZamIz

4. India’s Central Drugs Standard Control Organization (CDSCO) has released the guidelines for the safe disposal of expired and unused medicines by hospitals and the general public. The initiative is aimed at addressing the growing concerns of antimicrobial resistance and minimizing environmental hazards. 
Source: bit.ly/4iOmj7d
Source: bit.ly/4d3ywnf

5. Under the Stockholm Convention, 40 nations worldwide have agreed to phase out the use of chlorpyrifos, a hazardous pesticide on food crops. However, India secured a five-year exemption for its use on 12 essential crops to manage certain pests and termites, as well as the lack of immediate alternatives.
Source: bit.ly/4iL0q8M

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

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 Health Ministry has notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, enabling compounding of minor offences related to the manufacture, import, sale, or distribution of drugs, cosmetics, and medical devices. The move aims to simplify compliance and reduce the burden on the judiciary.
Source: bit.ly/3YVqxTl

2. India’s Central Drug Regulator has exempted orphan drugs from mandatory port testing. Importers must submit a legal undertaking to provide test results within 15 days of receipt from labs. This decision aims to address challenges like small volumes, high costs, and lack of specialized testing infrastructure.
Source: bit.ly/3S8NM8K

3. The Orissa High Court has held that doctors cannot be criminally liable for prescribing an expensive drug unless it is hazardous, sub-standard, or restricted. The Court also stated that government cannot compel patients to use cheaper, less effective drugs, especially if they are paying for treatment themselves.
Source: bit.ly/4jR6Eoq

4. The Supreme Court of India will examine whether excluding divorced and single men from availing surrogacy violates constitutional rights. A divorced man has challenged this exclusion, arguing it discriminates based on gender and marital status, infringing on fundamental rights.
Source: bit.ly/4jLJtMm

5. The Chhattisgarh Anti-Corruption Bureau (ACB) and Economic Offences Wing (EOW) have reportedly filed a chargesheet against six individuals involved in a ₹550 crore medical procurement scam. The accused inflated prices for medical supplies and used to procure medical supplies without verifying the actual requirements of health centers, causing major losses to the state exchequer.
Source: bit.ly/4iHo5XR

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 Technical Advisory Board is reportedly reviewing a proposal to limit the sale of over-the-counter drugs. Only 27 essential medicines, including painkillers, antacids, and oral contraceptives, may be allowed without a prescription, with strict controls on dosage and pack size.
Source: bit.ly/4jqjkD0

2. Delhi High Court has upheld the Government’s move to restrict the sale of an anti-cold drug without warning labels against use in children below 4 years after April 15, 2025. For earlier batches, companies must publish notices in two national newspapers, which won’t count as advertisements or violations of license conditions.
Source: bit.ly/3SaUOK0

3. India’s drug regulator has reportedly approved eye drops aimed at controlling myopia progression in children. This pediatric formulation, the first of its kind to be approved in India, has successfully completed Phase III trials and will be available as a prescription drug.
Source: bit.ly/444JxCp

4. A group of doctors with disabilities has urged the World Health Organisation to include sunscreen in its Essential Medicines List, citing its importance for people with albinism who are highly susceptible to UV radiation. They argued that sunscreen is a vital medical need and not a cosmetic.
Source: bit.ly/44KmxJ9

5. The U.S. FDA reportedly plans to phase out several synthetic food dyes linked to health concerns like attention deficit hyperactivity disorder (ADHD) and obesity. Two dyes will be banned soon, with six more to be removed by 2026, and new natural color additives will be approved.
Source: bit.ly/3EFTFXQ

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 Delhi High Court to hear a Public Interest Litigation filed against major e-commerce platforms, accusing them of failing to make their apps accessible to people with disabilities, which constitutes a violation of fundamental rights. The plea also urged that return and refund processes be made more accessible for visually impaired users.
Source: bit.ly/4jK5X0b

2. India’s Kerala High Court has ruled that clubs and associations cannot be taxed for services or welfare schemes provided to their own members, calling it unconstitutional. These transactions involve only one entity, violating tax principle that a person cannot be taxed for “self-supply” of services.
Source: bit.ly/4isU4e4

3. The Indian Government reportedly plans to introduce Quality Control Orders for cosmetics to ensure product quality and curb imports of substandard items. However, industry leaders have raised concerns about overlapping regulations, as existing Cosmetic Rules, 2020 already align with the guidelines of Bureau of Indian Standards.
Source: bit.ly/4jm0PiZ

4. India has reportedly blocked imports of US dairy products like butter and cheese due to concerns over US cattle feeding practices involving animal-based proteins. India demands changes to these practices or adherence to its vegetarian certification norms. The issue could affect ongoing trade negotiations.
Source: bit.ly/3EoJveh

5. The Competition Commission of India (CCI) has reportedly ruled that leading food delivery platform’s platform fees, food prices, and delivery charges are not unfair or discriminatory. This decision came after a complaint was filed accusing the company of abusing its dominant position in the food delivery market.
Source: bit.ly/3S1JkZo