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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 Central Pollution Control Board (CPCB) has extended the deadline for registered Producers, Importers and Brand Owners (PIBOs) to file Annual Returns for FY 2024–25 under the Plastic Waste Management Rules, 2016 until March 31, 2026. Non-compliance may attract environmental compensation.
Source: shortlink.uk/1rAfG

2. The Central Pollution Control Board has issued show cause notices to PIBOs for failing to meet EPR obligations and not submitting Annual Returns for FY 2022–23 under the Plastic Waste Management Rules, 2016. Defaulters will face environmental compensation and tighter enforcement from authorities
Source: shortlink.uk/1rAg8
Source: shortlink.uk/1rAga

3. The Central Pollution Control Board (CPCB) has issued show cause notices to producers, importers, and brand owners (PIBOs) for failing to meet Extended Producer Responsibility obligations, fulfil targets, and file annual returns under the Plastic Waste Management Rules, 2016 for FY 2022–23. Non-compliant entities may have to pay environmental compensation, face penalties, and higher future targets. Entities must respond latest by 26.03.2026or face further regulatory and legal action.
Source: shortlink.uk/1mol6

4. The Karnataka government has released a draft policy promoting responsible digital use among students, focusing on curbing screen addiction, cyber risks, and mental health impacts. The move aligns with its broader push to restrict social media access for minors and regulate device usage.
Source: shortlink.uk/1mol8

5. Parliamentary panel has reportedly urged the Department of Pharmaceuticals to address administrative delays affecting the Promotion of Research and Innovation in Pharma MedTech Sector scheme after significant underutilisation of funds. Despite increased allocations, spending remained low. Revised guidelines and stronger monitoring are expected to improve execution and outcomes.
Source: shortlink.uk/1rAgj

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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 government clarified no proposal exists for a uniform nationwide pricing framework for medical devices. National Pharmaceutical Pricing Authority continues to regulate ceiling prices for essential devices like stents and knee implants under Drugs Prices Control Order, 2013, while monitoring non scheduled products and taking action against overcharging to safeguard consumer interests.
Source: shortlink.uk/1mogz

2. The Ministry of Health and Family Welfare approved major reforms to strengthen food safety while improving ease of doing business. Measures include perpetual licences, higher turnover thresholds, deemed registration for street vendors, and risk based inspections, reducing compliance burden and enhancing regulatory efficiency
Source: shortlink.uk/1rAbJ

3. The National Biodiversity Authority (NBA) of India has formed an expert committee to address invasive alien species threatening India’s biodiversity, ecosystems, agriculture, and health. It will create a national list, identify high-risk species, and recommend management strategies, research, and guidelines for prevention, control, and ecological restoration over a two-year period.
Source: shortlink.uk/1mogO

4. The Delhi High Court has issued notices to the government and CDSCO over alleged inaction on misuse of diabetes drug Ozempic for weight loss, citing non-compliance with earlier directives. The case raises concerns on regulatory oversight, off-label use controls, and potential compliance risks for pharma players amid rising scrutiny.
Source: shortlink.uk/1mogP

5. A Parliamentary panel has asked the Ministry of Defence to expedite pending payments to hospitals under the Ex-Servicemen Contributory Health Scheme, warning that delays are forcing private providers to opt out. The move aims to restore service continuity and protect healthcare access for over one crore beneficiaries.
Source: shortlink.uk/1mogU

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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 Union Health Ministry, has reportedly directed all academic and research institutions under its purview to refrain from sharing data, trial results, or research information with foreign agencies without prior approval. Sectors including pharmaceuticals, animal sciences, and plant biotechnology have been flagged by Indian intelligence agencies for unauthorised informal engagements.
Source: shortlink.uk/1mobc

2. Central Drugs Standard Control Organization (CDSCO) of India has issued a notice stating that Sodium Hyaluronate Eye Drops 0.3% w/v are being manufactured and marketed without mandatory approval. Since it is classified as a new drug, prior permission is mandatory under the New Drugs and Clinical Trials Rules, 2019. State and UT authorities have been directed to cancel approvals and report compliance.
Source: shortlink.uk/1rA6g

3. Food Safety and Standards Authority of India (FSSAI) has integrated a Food Recall module into its FoSCoS compliance portal, enabling enforcement authorities and food businesses to log and monitor recalls online. Consumers can now check recalled product details on the FoSCoS homepage, strengthening food safety oversight across India’s food supply chain.
Source: shortlink.uk/1rA6l

4. The Central Pollution Control Board (CPCB) has issued show cause notices under the Environment (Protection) Act, 1986 to PIBOs for failing to meet EPR targets for FY 2022–23. The entities are required to submit their response within 15 days of issuance of notice along with fulfilment of obligation. The response should be shared to CPCB on email id along with the hard copy to divisional head Delhi.
Source: shortlink.uk/1mobG

5. US FDA has issued a draft guidance to help companies reduce animal studies of experimental drugs and adopt non-animal testing tools such as newer methods, such as computer simulations and devices that mimic functions of human organs. This guidance is issued because it signals a strategic shift toward integrating non-animal data in preclinical studies, reshaping global expectations for safety evidence generation.
Source: shortlink.uk/1mobN

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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 has urged the Union Government to enact a comprehensive law governing passive euthanasia and end of life care in India. The Court noted that the absence of legislation has repeatedly required judicial guidelines, while permitting withdrawal of life sustaining treatment for a patient in a prolonged vegetative state.
Source: short-url.org/1qSHk

2. The Drugs Technical Advisory Board (DTAB) has recommended amending entry no. 33 of Schedule K to permit only unflavoured nicotine gums (2 mg) under sale license exemptions. Nicotine lozenges (2 mg) are excluded. Sale to minors is prohibited, online access closely monitored, and marketing by the tobacco industry restricted.
Source: short-url.org/1qSHq

3. A Mumbai Sessions Court has set aside criminal proceedings against directors of an e-commerce platform in a case concerning alleged online sale of abortion pills. The court held that the company operates as an intermediary marketplace and cannot be held directly liable for products listed by third-party sellers, highlighting limits on platform liability in e-commerce
Source: short-url.org/1lJ8-

4. The Drugs Technical Advisory Board (DTAB) has recommended introducing a separate form for wholesale bulk drug licences to capture details of wholesalers dealing with NDPS substances. Qualification criteria for competent persons and adequate transition time for existing wholesaler licensees to obtain the new licence is also proposed by DTAB
Source: short-url.org/1lJ9e

5. The Central Drugs Standard Control Organization (CDSCO) has issued an advisory warning manufacturers, importers and marketing authorisation holders against direct or indirect promotion of prescription medicines, including GLP-1 receptor agonists. The regulator noted that surrogate advertising, misleading efficacy claims and promotional campaigns increasing product visibility may constitute misleading marketing practices.
Source: short-url.org/1lJ9i

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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 issued a draft notification proposing revisions to blood product testing requirements. It proposes that products must comply with standards in the Indian Pharmacopoeia, or where unavailable, the United States or British Pharmacopoeia, and removes the requirement to test final products for HIV-I, HIV-II, Hepatitis B surface antigen, and Hepatitis C antibodies.
Source: short-url.org/1lAp8

2. The Central Drugs Standard Control Organisation (CDSCO) has enabled online submission of applications for licences to manufacture recombinant deoxyribonucleic acid based drugs under Forms 28D and 28DA through the Online National Drugs Licensing System (SUGAM portal). From 10 March 2026, the regulator will no longer accept physical applications.
Source: short-url.org/1qJFy

3. The 93rd meeting of the Drugs Technical Advisory Board (DTAB), held on 16 February 2026, reviewed key technical and regulatory matters under the Drugs and Cosmetics Act and Rules. The board discussed policy recommendations, regulatory amendments, and technical issues affecting pharmaceuticals, biologics, and medical products, guiding future regulatory updates.
Source: short-url.org/1qJFF

4. India’s Telangana Drugs Control Administration has launched a bulk SMS alert system to instantly notify pharmacies and wholesalers about Not of Standard Quality (NSQ) drugs, enabling rapid recalls of sub standard drugs, strengthening regulatory monitoring, supply-chain transparency, and patient safety across the state’s pharmaceutical market.
Source: short-url.org/1lApq

5. The Technology Development Board of Government of India has extended financial support to commercialise a rapid diagnostic kit for childhood diarrhea, aimed at enabling faster detection of infections in paediatric patients.
Source: short-url.org/1lApu

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 Central Drugs Standard Control Organization (CDSCO), has enabled online submission of Post-Approval Changes (PAC) for Marketing Authorization related to r-DNA biological products through the CDSCO online portal. Offline submissions of PAC applications will be discontinued from March 5, 2026.
Source: short-url.org/1qFRp

2. The Indian government reportedly plans to train 100,000 allied health professionals over five years and expand caregiver training programmes to strengthen the healthcare workforce. The initiative will upgrade institutions, standardize training across disciplines and improve healthcare access and service quality nationwide.
Source: short-url.org/1qFRF

3. European Union has introduced a new Detergents and Surfactants Regulation requiring stricter biodegradability standards and a mandatory Digital Product Passport (DPP) for products sold in the EU. The regulations also restrict phosphates, update labeling requirements, regulate microorganism-based detergents, and ban animal testing to improve environmental protection and product transparency.
Source: short-url.org/1lwJ9

4. Delhi Drugs Control Department reportedly seized insulin stocks worth over ₹20 lakh from four wholesalers during a special enforcement drive. Inspections revealed violations of the Drugs and Cosmetics Act, 1940, including insulin meant for government supply being diverted, lack of purchase records, and storage of insulin at room temperature instead of required cold chain conditions.
Source: short-url.org/1qFRN

5. Delhi’s Central Procurement Agency (CPA) has reportedly issued a directive instructing government hospitals and allied institutions to stop issuing independent tenders for medical equipment and supplies. The notice reiterates that all procurement activities must be routed through the CPA to ensure centralized purchasing and maintain uniform pricing across hospitals. Hospitals have been warned against conducting separate tendering processes without CPA approval.
Source: short-url.org/1qFRR

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 Central Drugs Standard Control Organisation (CDSCO) has introduced a prior intimation system for the submission of applications for analytical or non-clinical testing in Forms CT-10, CT-12, and CT-13 under the New Drugs and Clinical Trials Rules, 2019 through the National Single Window System (NSWS) portal. The system does not apply to sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, or narcotic and psychotropic substances.
Source: short-url.org/1qC6E

2. The Government of India is reportedly considering stricter regulation of nicotine lozenges to curb access by minors and non-smokers. The Drugs Technical Advisory Board (DTAB) has reportedly recommended removing 2 mg nicotine lozenges from the exemption, which currently allows certain nicotine replacement therapy (NRT) products to be sold without a drug sale licence. If implemented, nicotine lozenges would largely be restricted to sale through licensed pharmacies.
Source: short-url.org/1lt4O

3. India’s central food regulatory authority (FSSAI) has recently in a Central Advisory Committee meeting urged states and UTs to strengthen enforcement against high-risk food commodities such as milk, edible oils, spices and honey. It called for risk-based inspections, faster recruitment of food safety officers, improved grievance redressal systems, and data-driven surveillance to strengthen monitoring and improve nationwide food safety oversight.
Source: short-url.org/1lt4V

4. Karnataka government has reportedly proposed banning the use of social media by children under the age of sixteen. Chief Minister Siddaramaiah announced the move during the state budget speech, stating that the measure aims to reduce the harmful effects of excessive mobile phone usage on minors across the state.
Source: short-url.org/1lt4-

5. India has outlined a five-pillar strategy to integrate artificial intelligence across healthcare, focusing on governance, data platforms, innovation, workforce capacity, and real-world validation. The framework aims to scale AI-driven diagnostics, public-health surveillance, and digital health infrastructure for pharma, med-tech, and health-tech companies to collaborate in data-driven healthcare innovation.
Source: short-url.org/1lt50

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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 licensing authority, CDSCO has issued an alert on the theft of Lantus® SoloStar® insulin (Batch No. 5F0347B) belonging to Sanofi India during transit in Odisha. As the product requires cold-chain storage at 2–8°C, quality risks exist. CDSCO has issued an advisory to healthcare professionals, patients and regulators.
Source: short-url.org/1qgYH

2. India’s central drug regulator reportedly circulated a proposal from the Ministry of Cooperation that would allow Primary Agricultural Credit Societies (PACS) to operate Jan Aushadhi Kendras without registered pharmacists through restricted drug licences, aiming to expand access in underserved areas. The pharmacist community has raised serious concerns, arguing this move could weaken professional standards and patient safety.
Source: short-url.org/1qgYM

3. The Food Safety and Standards Authority of India has issued draft amendments to the Food Products Standards and Food Additives Regulations, 2011 proposing several changes. Stakeholders may submit objections or suggestions within sixty days from publication of the notification. The authority will consider all representations before finalising the proposed regulatory amendments.
Source: short-url.org/1qgYz

4. A court has granted interim relief in a trademark dispute involving the shape of a toilet cleaner bottle. It held that product shape can receive trademark protection even after design registration expires. Observing strong similarity between competing bottles, the court restrained sale of the allegedly infringing product pending further proceedings.
Source: short-url.org/1qgZN

5. The Madras High Court has stayed a single judge’s observation declaring the term “Vapo” as public property in a trademark dispute concerning vapour-based medicinal rubs. The Division Bench held that the finding requires further examination, while allowing continued use of the contested registered mark pending adjudication of the appeals.
Source: short-url.org/1l8DX

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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 Delhi high court granted ex-parte interim injunction to major manufacturer of toothpaste, directing social media platforms to take down the defamatory content pending further proceedings which is falsely claiming that Dant Kanti toothpaste causes cancer. The court found the claims prima facie malicious and unsubstantiated.
Source: short-url.org/1l8us

2. The High Court of Bombay has granted permanent injunction protecting registered mark ZERODOL against use of ZEKODOL-P for identical pharma products. Court found strong phonetic and visual similarity, holding confusion in medicines unacceptable. Defendant restrained and directed to pay directed to pay costs.
Source: short-url.org/1qgQf

3. The CDSCO is reportedly set to formally involve Quality Council of India-certified notified bodies in its drug regulatory audit framework to boost coverage and compliance monitoring, addressing capacity constraints in current inspections. The reform, aligned with global standards, would expand third-party audit participation alongside plans to grow internal scientific review teams.
Source: short-url.org/1qgQx

4. The Central Drugs Standard Control Organization will reportedly replace its existing SUGAM regulatory portal with a modern open-architecture digital platform, following approval by the Department of Expenditure. The new system aims to integrate the entire drug regulatory value chain, improve transparency and efficiency, and streamline licence, import/export and regulatory approval processes across India.
Source: short-url.org/1l8uE

5. The National Medical Commission has directed all medical colleges to integrate the HMIS of their attached hospitals with the Ayushman Bharat Digital Mission (ABDM-HMIS) portal within 15 days. Issued under UGMSR 2023 compliance, the move aims to enhance transparency, objective assessments and digital monitoring of medical education standards.
Source: short-url.org/1qgSQ

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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, CDSCO has directed state drug regulators to direct manufacturers of Doxycycline formulations to incorporate CNS side Effects as an adverse drug reaction such as restlessness, anxiety, irritability, nervousness, and dizziness in the caution section of the package insert/ Promotional literature following recommendation by the Subject Expert Committee on Antimicrobial and Ant Parasite.
Source: short-url.org/1perz

2. India’s National Consumer Disputes Redressal Commission (NCDRC) ruled that prescribing allopathic medicines without a recognised medical qualification is negligence and deficiency in service. It directed an eye centre to pay ₹2 lakh compensation plus interest to a patient who permanently lost vision due to such unqualified prescriptions.
Source: short-url.org/1k96-

3. The Directorate of Drugs Control under the Government of Tamil Nadu has issued a public advisory warning citizens against the manufacture, sale and online distribution of unapproved oral nicotine pouches. Show-cause notices have been served to major online sellers for marketing products whose safety, efficacy and quality have not been established in India.
Source: short-url.org/1perD

4. The Multidisciplinary Committee advising the National Pharmaceutical Pricing Authority has recommended a five-year exemption from the Drug Price Control Order, 2013 for nafithromycin, India’s first indigenous antibiotic. The move follows patent confirmation by the Central Drugs Standard Control Organisation and the Indian Patent Office, allowing pricing flexibility and encouraging domestic antibiotic innovation.
Source: short-url.org/1k973

5. India’s National One Health Mission has reportedly invited expressions of interest from qualified organisations to develop artificial intelligence tools for early detection of emerging pathogens across human, animal and environmental systems. The government-backed programme will fund research and development to strengthen disease surveillance and pandemic preparedness nationwide efforts.
Source: short-url.org/1k977