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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 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

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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 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

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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. 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

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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 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

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 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

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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

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 Madras High Court has imposed a ban on the manufacture, sale, transport, and use of 28 types of single-use plastic items across the areas like the Nilgiris, Kodaikanal, and the Agathiyar Biosphere. Banned items include plastic bottles, food wrapping films, thermocol plates and cups, plastic-coated tableware, straws, carry bags, etc.
Source: bit.ly/3RmpHuX

2. Indian food regulator FSSAI, in response to an RTI, has stated that it lacks authority to regulate baby milk products under the Infant Milk Substitutes, Feeding Bottles, and Infant Foods (Regulation of Production, Supply and Distribution) Act, which regulates baby food marketing, placing enforcement responsibility on the Women and Child Development Ministry.
Source: bit.ly/4lDCPts

3. India’s Health Ministry has released a notification restricting the manufacture and sale of a popular anti cold drug until there is a warning on labels stating they should not be used in children below four years. The notification will take effect from the date of its publication in the Official Gazette.
Source: bit.ly/3Y54v08

4. Private hospitals in Nagaland have reportedly suspended admitting patients under Ayushman Bharat, Pradhan Mantri Jan Aarogya Yojana and Chief Minister Health Insurance Scheme from April 17, 2025, due to unpaid dues. The Nagaland Private Doctors Association urged authorities to resolve the issue so services can resume without further delay.
Source: bit.ly/4cAsslY

5. The UK Government has enacted significant reforms to clinical trials regulation. Effective from April 11, 2025, with full implementation by April 2026, the new rules aim to streamline trial approvals, enhance patient safety, enable innovation, and help more people benefit from participating in vital research.
Source: bit.ly/4jDT5ZC

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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 Pollution Control Board (CPCB) has released guidelines for the establishment and operation of Common Bio-Medical Waste Treatment and Disposal Facilities (CBWTFs). These guidelines cover site selection, treatment technologies, infrastructure, record-keeping, and compliance monitoring to standardize practices across India.
Source: bit.ly/4jos50r

2. India’s Central Pollution Control Board (CPCB) has issued show cause notices to 11 Plastic Waste Processors (PWPs) for allegedly selling recycled plastic at unreasonably low prices. CPCB has ordered the cancellation of their registrations and imposed environmental compensation. The PWPs are required to respond or take appropriate action within 10 days from the date of issuance of the notice.
Source: bit.ly/42Jrbom

3. India’s Central Government has notified an amendment to the list of psychotropic substances under the Narcotic Drugs and Psychotropic Substances Act, 1985. Pursuant to this amendment, the following substances have been included in the list of psychotropic substances: 3-Chloromethcathinone (3-CMC), Dipentylone, 2-Fluorodeschloroketamine, and Bromazolam.
Source: bit.ly/4jFxhwM

4. A sunscreen brand has agreed to take down and modify its advertisement campaign disparaging a competitor brand by claiming that it is ineffective, causes skin pigmentation and makes misleading claims. The modification will include removing the term “online bestseller” and other references.
Source: bit.ly/4jmLrDm

5. The Food Safety and Standards Authority of India (FSSAI) has released a consultation on compliance with provisions of ‘Analogue in Dairy Context’ and is inviting public comments from the stakeholders. The authority aims clearly bifurcate ‘Dairy Analogues’ from regular dairy products. Stakeholders can send their suggestions by 15th June 2025.
Source: bit.ly/42w1ZBl