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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 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

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. Bombay High Court restrained use of the mark Esiraft, finding it deceptively similar to an existing registered trademark Raciraft and likely to cause consumer confusion. The ruling reinforces strict standards on phonetic and visual similarity, strengthening protection against trademark infringement and passing off in the pharmaceutical sector.
Source: shortlink.uk/1sTZo

2. The U.S. Food and Drug Administration (USFDA) has released draft guidance on using next-generation sequencing (NGS) to assess gene therapy safety, detecting off-target edits, evaluating insertional mutagenesis, assessing vector integration sites, and ensuring genomic integrity. This is important as it strengthens detection of unintended genetic changes. If finalized, developers must adopt validated NGS methods and enhanced data reporting in IND submissions.
Source: shortlink.uk/1sTZq

3. The Food Safety and Standards Authority of India (FSSAI) has introduced flexibility in payment timing for visual inspection and laboratory testing charges under the FICS/SWIFT system, allowing importers to make payments after inspection instead of upfront. This is important as the move improves cash-flow management, reduces clearance delays, and enhances ease of doing business. Importers should now align internal payment and clearance workflows to leverage the revised process and avoid procedural bottlenecks.
Source: shortlink.uk/1sTZu

4. The U.S. Food and Drug Administration issued a warning to a major medical supply manufacturer over defective angiographic syringes used in heart procedures following multiple complaints related to device disconnections and potential patient and clinician safety risks. The company recalled the syringes in March 2026 but the FDA warned that failure to address the violations could result ‌in seizure of products, court action or financial penalties.
Source: shortlink.uk/1nEv0

5. The U.S. Food and Drug Administration has asked a weight-loss drug giant manufacturing giant to submit additional safety data for its newly approved oral weight-loss pill, including post-marketing studies on liver injury, cardiovascular risks, delayed gastric emptying, and drug presence in breast milk. This highlights tightening of post-market surveillance scrutiny, and evolving safety requirements for next-generation weight-loss therapies.
Source: shortlink.uk/1sTZz

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 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