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 Department of Consumer Affairs has clarified that customary units such as inches, feet, yards and square feet may be used only as supplementary declarations alongside standard SI units under the Legal Metrology framework. The clarification aims to ensure uniformity in trade practices while preventing misleading or ambiguous quantity declarations for consumers.
Source: shortlink.uk/1vwL3

2. FSSAI plans to centralize food surveillance by separating sampling from enforcement, reducing state officers’ discretionary powers. Neutral agencies will collect samples, with results uploaded to a national database for quick alerts. This aims to enhance transparency, consistency, and consumer safety while ensuring enforcement remains with state authorities.
Source: shortlink.uk/1vwJ8

3. The Supreme Court has directed Delhi authorities to urgently frame a Standard Operating Procedure (SOP) ensuring private hospitals built on concessional government land provide free treatment to Economically Weaker Section (EWS) patients, addressing widespread non-compliance with the mandate of reserving 10% inpatient beds and 25% outpatient services.
Source: shortlink.uk/1q97l

4. The CDSCO has directed state and Union Territory drug regulators to closely monitor surrogate advertising and promotional activities related to prescription GLP-1 drugs used to treat obesity and metabolic disorders. The regulator has cautioned against indirect promotional practices, including disease-awareness campaigns and digital outreach, that could influence public demand for prescription-only medicines. The move signals intensified regulatory scrutiny of marketing, distribution, and promotion, and may also lead to stricter compliance expectations for pharmaceutical companies, digital platforms, wellness clinics, and marketers involved.
Source: shortlink.uk/1q96J

5. The Indian Council of Medical Research (“ICMR”) has introduced a single-window approval mechanism for medical research studies, replacing the earlier fragmented process requiring approvals from multiple ethics committees and institutions. The framework is intended to streamline ethics clearances, reduce procedural delays, and accelerate approvals for multicentric and collaborative research projects.
The development is significant for India’s clinical research ecosystem as it is expected to improve regulatory efficiency, transparency, and coordination in study approvals.
Source: shortlink.uk/1q96K

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. Central Drugs Standard Control Organisation (CDSCO) has issued a public notice under the Drugs and Cosmetics Act, 1940 and Cosmetics Rules, 2020, prohibiting use of cosmetics as injectable preparations by consumers, professionals, or aesthetic clinics. The notice flags four key violations: use of GNRAS or prohibited ingredients per BIS standards, misleading or false labelling claims, tampering with manufacturer inscriptions, and use of cosmetics for treatment purposes beyond their statutory scope of cleansing, beautifying, promoting attractiveness, or altering appearance.
Source: shortlink.uk/1vo9D

2. The Karnataka High Court has stayed criminal proceedings in a case involving the alleged sale of pirated books on an e-commerce marketplace, with the platform arguing that it functions solely as an intermediary and does not directly control third-party seller listings. The development brings renewed focus to intermediary liability and the extent of safe harbour protections available to e-commerce platforms under Indian laws.
Source: shortlink.uk/1vo9I

3. The High Court of Himachal Pradesh has quashed criminal proceedings against a pharma unit initiated by a Central drug inspector, holding that prosecution for manufacture, sale and distribution of drugs lies with State authorities and not the Central Government. The ruling clarifies the limits of enforcement powers of central drug regulator and may affect similar cases initiated by CDSCO against pharmaceutical manufacturers.
Source: shortlink.uk/1q0Oz

4. The Central Drugs Standard Control Organisation has reportedly initiated a review of concerns raised by retail chemists over the functioning of electronic pharmacies. Following assurances from the regulator, several state pharmacy associations have declined to participate in the proposed nationwide strike to avoid disruption in the supply of essential medicines and protect patient interests.
Source: shortlink.uk/1vo9S

5. A US federal jury found a major pharmaceutical company liable for delaying a generic version of a blockbuster constipation drug through an anticompetitive “pay-for-delay” arrangement. The verdict awarded nearly USD 885 million in damages and heightened scrutiny of delayed generic entry practices. The ruling may increase antitrust, litigation, and compliance risks for pharmaceutical companies globally.
Source: shortlink.uk/1q0OM

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 licensing authority (“CDSCO”) has issued a detailed FAQ document clarifying procedural and compliance requirements relating to prior intimation for Bioavailability (BA) and Bioequivalence (BE) studies for drugs meant for export purposes, under the amended provisions introduced through a notification. The guidance addresses limitations, submission timelines, documentation expectations, and regulatory processes for study sponsors and contract research organisations.
Source: shortlink.uk/1pHxP

2. The Central Drugs Standard Control Organisation (CDSCO) is reportedly working on regulatory guidelines for the use of high-risk solvents amid concerns over Propylene Glycol and its toxic impurities, Diethylene Glycol (DEG) and Ethylene Glycol (EG), in paediatric oral medicines like cough syrups. The move aims to strengthen quality checks, improve ingredient oversight, and prevent future contamination-related public health incidents.
Source: shortlink.uk/1v3ev

3. The Karnataka High Court has stayed the FSSAI advisory restricting the use of Ashwagandha leaves and leaf extracts in health supplements, providing interim relief to nutraceutical and wellness companies using such ingredients in their products. The Court observed that such restrictions may require amendments instead of being introduced through an advisory mechanism alone. This is important as the advisory had created restrictions for manufacturers operating in the nutraceutical and Ayush sectors using Ashwagandha. The order temporarily allows continued use of Ashwagandha leaf extracts while the larger regulatory and legal validity of the restriction is examined.
Source: shortlink.uk/1v3eB

4. India’s drug regulator has directed all 4,153 licensed blood banks to register on ONDLS portal on priority, as part of HIV infections in children due to contaminated transfusions linked to unsafe transfusions. Every blood center must register itself regardless of the status of their license.
Source: shortlink.uk/1v3eQ

5. The European Union has included India in its revised draft list allowing continued export of Indian aquaculture products from September 2026, bringing major relief to India’s seafood industry after the country’s earlier exclusion in 2024. The decision follows India’s compliance with European food safety and antimicrobial regulations.
Source: shortlink.uk/1v3eW

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 advised stakeholders to submit clinical trial protocols simultaneously to CDSCO and Ethics Committees under Chapter III of the New Drugs and Clinical Trial Rules, 2019. This is important as it aims to reduce approval timelines and improve regulatory efficiency, enabling faster initiation of clinical trials and quicker patient access to innovative therapies.
Source: shortlink.uk/1pAw-

2. The Parliamentary Panel on Health and Family Welfare has reportedly urged the Ministry of AYUSH to strengthen international cooperation by prioritising partner countries for joint research, clinical studies, academic exchanges and capacity building in traditional medicine. The panel also recommended improving the Ayush Global Portal for better accessibility and global engagement. it could improve scientific validation, expand international acceptance of Ayurveda and yoga, and enhance India’s global influence in healthcare.
Source: shortlink.uk/1pAx1

3. The Food Safety and Standards Authority of India has reportedly issued a show-cause notice to a clean label food brand over claims that its chocolates contain “no added sugar” despite using dates and date powder as sweeteners. The action follows complaints by a rival brand and raises questions over compliance with FSSAI’s rules over claiming “non-addition of sugars”. The dispute could influence how food companies market sugar-free or no-added-sugar products in India’s growing chocolate sector.
Source: shortlink.uk/1uVZF

4. Private hospital associations have raised concerns over CGHS reimbursement caps, warning that limiting payouts to 70% of MRP for high-cost immunotherapy drugs may hinder access to advanced cancer care. This is important as this could increase patient costs, restrict use of costly treatments, and strain hospitals’ ability to provide life-saving oncology therapies.
Source: shortlink.uk/1pAx9

5. A lawsuit filed in California has raised concerns around AI-generated health and substance-use advice after allegations that chatbot interactions contributed to a teenager’s fatal overdose. The suit reportedly alleges that unsafe guidance on drug combinations was provided without adequate safeguards or warnings. The matter reflects growing regulatory oversight for AI tools used in healthcare, mental health, and wellness contexts.
Source: shortlink.uk/1pAxb

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 issued an advisory directing manufacturers and importers to submit Periodic Safety Update Reports (PSURs) from the actual marketing date of new drugs, not approval date. The regulator also mandated consolidated PSUR submissions covering all dosage forms and indications to prevent duplication and improve post-marketing safety monitoring. This is important because accurate PSUR timelines strengthen drug safety surveillance and help regulators detect adverse effects more effectively.
Source: shortlink.uk/1uTal

2. India’s central drug licensing authority has reportedly directed states to intensify action against the illegal sale and misuse of sexual enhancement drugs such as sildenafil, varde¬na¬fil and tadalafil, citing public safety and social concerns. The regulator has ordered raids against illegal clinics, pharmacies, and online platforms, alongside stricter monitoring, awareness measures, and legislative action to curb unauthorized sales without prescriptions.
Source: shortlink.uk/1uTas

3. The Delhi High Court granted interim relief in a trademark and copyright dispute concerning sexual wellness products marketed under the “Stand Up” branding. The Court found the competing packaging and labels deceptively similar and ordered removal of online listings, while restraining further use of the disputed branding pending adjudication.
Source: shortlink.uk/1uTax

4. The Delhi Commercial Court has granted a permanent injunction restraining the defendants from manufacturing, selling, or dealing in cosmetics under the deceptively similar “ROOP LADY” trademark and sindoor bottle design, holding that the defendants had no proprietary rights over the impugned mark/design and that their activities amounted to trademark infringement, design piracy, copyright infringement, and passing off. This is important as the ruling reinforces judicial protection of intellectual property rights in the cosmetics and personal care sector, particularly against counterfeit and deceptively similar products that may mislead consumers and dilute brand goodwill.
Source: shortlink.uk/1pxNP

5. Maharashtra’s State Blood Transfusion Council (SBTC) has reportedly launched stricter oversight of blood banks following reports of profiteering through the sale of excess plasma at inflated rates. The council has introduced a 50-point inspection checklist and warned against over-collection and unauthorized plasma transfers, aiming to strengthen ethical blood banking practices and patient safety.
Source: shortlink.uk/1uTaS

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 pharmaceutical industry has strengthened its position as the “Pharmacy of the World”, exporting affordable medicines and vaccines to more than 200 countries. The sector now earns over half its revenue from exports, supplies vaccine demand, and is expected to reach 130 billion dollars value by 2030.
Source: shortlink.uk/1uSYh

2. The All India Institute of Medical Sciences (AIIMS), New Delhi has introduced India’s first portable bedside MRI system for critically ill patients in ICUs and emergency settings. This is significant as it enables rapid brain imaging without shifting unstable patients, improving timely diagnosis, monitoring, and critical care outcomes.
Source: shortlink.uk/1uSYo

3. India’s Directorate General of Health Services has introduced its first comprehensive framework for Intensive Care Units (ICUs), laying down standardized norms. ICUs have been categorised into 3 levels, with each level prescribed minimum bed strength, infrastructure and equipment requirements, staffing ratios, and specialist qualifications.
Source: shortlink.uk/1pxBR

4. The Food Safety and Standards Authority of India (FSSAI) seized misbranded “alkaline water” products for alleged use of non-permitted ingredients and labelling violations, signalling increased scrutiny of functional and packaged drinking water products in the west region. The action highlights growing regulatory focus on misleading health claims, ingredient disclosures, and compliance with Indian food safety and labelling laws.
Source: shortlink.uk/1uSYx

5. The Union Health Ministry has launched JANANI (Journey of Antenatal, Natal and Neonatal Integrated Care), a QR-enabled digital platform aimed at strengthening maternal and child healthcare through longitudinal digital health records. The platform will track antenatal care, delivery, postnatal care, newborn care, and family planning services. The initiative is significant as it seeks to improve continuity of care, enable real-time monitoring of high-risk pregnancies, and strengthen technology-enabled public healthcare delivery across India.
Source: shortlink.uk/1uSYA

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 pharmaceutical company has paused its obesity awareness campaign in India following an advisory from CDSCO against surrogate promotions that may indirectly lead consumers to a medicine, which is prohibited across media platforms. This is important as Indian regulators are increasingly monitoring disease-awareness and indirect promotional campaigns to ensure adherence to drug advertising, particularly in rapidly growing therapy areas such as obesity management. Going forward, pharmaceutical and healthcare companies may face tighter scrutiny over patient awareness initiatives, digital outreach, and indirect marketing strategies, requiring stronger alignment with India’s evolving compliance and promotional framework.
Source: shortlink.uk/1uSTv

2. Manufacturers of platinum-based cancer medicines have reportedly urged the NPPA to revise the ceiling prices of regulated chemotherapy drugs such as cisplatin, carboplatin, and oxaliplatin after platinum API costs surged by nearly 200%–300%, making production commercially unviable. The industry warned that unchanged price caps could disrupt supplies of essential cancer medicines and adversely impact patient access to critical treatments.
Source: shortlink.uk/1pxx5

3. Pharmaceutical exporters continue to face delays in obtaining World Health Organization Good Manufacturing Practices Certificates (WHO-GMP) of Pharmaceutical Products through the Online National Drug Licensing System portal. Industry bodies warned that technical glitches and processing delays are disrupting exports and international regulatory commitments.
Source: shortlink.uk/1uSTF

4. The Uttarakhand High Court granted bail to a snake venom collector accused of illegally possessing venomous snakes and extracted venom. The court noted his licence had expired and renewal was pending, suggesting procedural lapses rather than deliberate wildlife trafficking. The case highlights regulatory and compliance sensitivities surrounding wildlife-derived substances used in research and pharmaceutical applications.
Source: shortlink.uk/1uSTJ

5. Singapore’s Health Sciences Authority (HSA), participating in INTERPOL’s Operation Pangea XVIII, removed 959 illegal online health product listings and seized 6,641 units of unregistered medicines and medical devices at borders. Operation Pangea XVIII is a coordinated enforcement drive across 90 countries targeting illegal and counterfeit health products. The crackdown targeted products including contact lenses, ivermectin, dermal fillers, and prescription medicines. HSA also warned 152 sellers and cautioned consumers against purchasing illegal or self-administered health products online due to serious safety risks.
Source: shortlink.uk/1uSTM

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 of India is considering capping billing margins charged by private hospitals on medical devices to curb overcharging and reduce treatment costs. This is important as excessive markups increase patient expenses and insurance premiums. If implemented, it will limit hospital margins, improving pricing transparency and affordability.
Source: shortlink.uk/1olUB

2. The Central Government has established the Online Gaming Authority of India (OGAI), with effect from May 1, 2026, under the Promotion and Regulation of Online Gaming Act, 2025, to regulate the gaming sector. Operating under MeitY, this multi-sectoral authority will oversee licensing, mandate registration for esports, and enforce stringent compliance requirements, with a view to enhancing user safety and strengthening regulatory oversight of online gaming.
Source: shortlink.uk/1tDQe

3. Indias central drug ministry has proposed amendment to Drugs Rules 1945 by expanding the list of licences that may be exempted from requiring a Form 29 licence for manufacturing of drugs for test or analysis. The amendment proposes to include Forms 25A (loan licences), 25F (Schedule X drugs), 28A/28B (Schedule C, C(1), and X drugs), 28D/28DA (vaccines, sera, r-DNA drugs), and 28F (umbilical cord blood stem cells). Objections and suggestions from the industry will be considered for thirty days.
Source: shortlink.uk/1tDQk

4. The Delhi High Court has restrained the use of the trademark “MARQ,” finding it deceptively similar to “MARC” and likely to confuse consumers. This reinforces trademark protection by emphasizing that minor spelling differences, use of house marks, or later registrations do not override prior rights and established goodwill.
Source: shortlink.uk/1tDQs

5. Government of India plans a Health Claims Index to transparency and standardize pricing in India health insurance sector. Using anonymized data from the National Health Claims Exchange, it will benchmark claims timelines, approvals and costs, enabling underwriting, reducing inefficiencies, and supporting informed consumer decisions, subject to scale and execution.
Source: shortlink.uk/1olUW

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. Parliament passes Jan Vishwas Bill 2026, bringing major relief to India’s cosmetics sector. Minor violations in the case of cosmetics (other than spurious or adulterated) which were previously punishable with up to one year’s imprisonment will now be resolved outside courts through a civil penalty framework, with fines of Rs.1 lakh or three times the value of confiscated goods, whichever is higher.
Source: shortlink.uk/1sCvW

2. The Central Government has amended Para 2.62 of the Foreign Trade Policy 2023 to streamline the issuance and verification of Certificates of Origin (CoO). The amendment clarifies that only Directorate General of Foreign Trade (DGFT)-authorised agencies can issue CoOs, and mandates exporters to use identical invoice numbers in both CoOs and corresponding shipping bills to enable automated verification.
Source: shortlink.uk/1sCw6

3. India’s leading manufacturer of Paracetamol tablets and active pharmaceutical ingredients plans to digitise manufacturing records, enhance quality oversight, and increase real-time monitoring after the U.S. Food and Drug Administration cited record-keeping gaps, cleaning lapses, and contamination control failures at its largest Telangana facility. While production continues, the warning may delay approvals for new products targeting the U.S. market.
Source: shortlink.uk/1sCwc

4. U.S. Food and Drug Administration (US FDA) recently issued a warning to Texas medical spa after finding it used more Botox than it had officially bought. Inspectors also discovered an unlabeled vial and poor record-keeping. Authorities said the spa may have sourced products from unauthorized suppliers, raising concerns about safety and possible risks to patients receiving treatments.
Source: shortlink.uk/1nnzV

5. The Government is reportedly considering mandating that vaccines and biological products undergo batch testing exclusively at authorised government institutions such as the National Institute of Biologicals, potentially excluding private labs. The move aims to strengthen quality oversight, standardise testing, and enhance regulatory control over biologics manufacturing and release.
Source: shortlink.uk/1sCwi

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 ruled that India’s central food authority, Food Safety and Standards Authority of India (FSSAI) cannot regulate animal or cattle feed under the Food Safety and Standards Act, 2006, holding that the law is limited to food meant for human consumption. The Court quashed FSSAI regulations restricting use of meat and bone meal in feed for milk- and meat-producing animals, citing lack of statutory authority.
Source: shortlink.uk/1sjFt

2. Telangana Health Minister has reportedly declared cancer a notifiable disease and launched a cancer registry to improve surveillance and care. With thousands of new cases, the initiative aims to strengthen data driven planning, expand treatment infrastructure, and introduce artificial intelligence based screening across government hospitals.
Source: shortlink.uk/1n5jM

3. The Drugs Technical Advisory Board has decided not to pursue the proposal to mandate pharmaceutical companies to allocate at least 1 percent of net profits towards free medicines under Corporate Social Responsibility (CSR). The decision follows clarification that CSR obligations fall under the Companies Act, 2013 and not under Drugs and Cosmetics Act and Rules made thereunder.
Source: shortlink.uk/1n5jP

4. The Directorate General of Foreign Trade (DGFT) of India, has permitted export of an additional 5 lakh metric tonnes of wheat flour and related products under HS Code 1101, while maintaining the “prohibited” export status. This quota comes over and above the 5 LMT allowed in January 2026, with detailed export modalities to be notified separately.
Source: shortlink.uk/1sjGG

5. The Court granted an ex parte ad interim injunction restraining the use of the mark “HIMALAYA THE NUTRA HEALTH CARE”, holding it to be deceptively similar to the plaintiff’s registered trademarks and trade dress. The Court noted the plaintiff’s long-standing presence, and global operations, and found that the impugned mark was likely to cause consumer confusion, constituting prima facie infringement
Source: shortlink.uk/1sjFF