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. The National Pharmaceutical Pricing Authority (NPPA) has notified a 0.64956% increase in the Wholesale Price Index (WPI) for 2025 over 2024. Importers and manufacturers of Scheduled drugs and medical device are now permitted to increase the prices on the basis of WPI without prior approval from the government from April 1, 2026.
Source: shortlink.uk/1mYsg

2. The Central Drugs Standard Control Organization (CDSCO) has clarified that all IVF-related devices, including sperm washing kits and intrauterine insemination tools, are regulated as medical devices under the Drugs and Cosmetics Act. Import, manufacture, and sale of these devices require proper licensing to ensure compliance and prevent unauthorized trade.
Source: shortlink.uk/1mYsj

3. India’s Central Drug authority, (CDSCO) has streamlined the procedure for review and processing Written Confirmation certificate (WCC) applications submitted through the SUGAM portal for export of Active Pharmaceutical Ingredients (API) to EU for human use. The move aims to improve efficiency aligning with EU GMP compliance requirements under Article 46(2)(b) of Directive 2001/83/EC.
Source: shortlink.uk/1sbyd

4. The National Medical Commission (NMC), following a Supreme Court of India ruling, now limits stem cell therapy to approved conditions only, so far there are 32 approved conditions. Unproven uses outside clinical trials are banned, with strict ethical rules and legal action to prevent misuse and protect patients.
Source: shortlink.uk/1mYsV

5. The Central Consumer Protection Authority (CCPA) has directed hotels and restaurants to stop adding charges such as “LPG charges” and “fuel cost recovery” to customer bills, terming the practice an unfair trade practice, and warning of strict action. The CCPA clarified LPG and electricity, are part of running a business and should be factored into final menu prices.
Source: shortlink.uk/1mYt2

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