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