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 multinational pharmaceutical company has approached the Delhi High Court to restrain the domestic pharma giant from launching its generic version of semaglutide, a widely prescribed drug for diabetes and weight loss. This is the second suit by the plaintiff innovator against local firms wanting to launch copies of the drug
Source: h7.cl/1g6X3
2. Department for Promotion of Industry and Internal Trade (DPIIT) has issued a draft framework mandating blanket licence for legally accessible content for AI-training, but deferring royalty payments until commercialisation. The plan sets up a centralised royalty-collection mechanism, replacing “zero-price licence” proposals.
Source: h7.cl/1g6X7
3. The Delhi High Court has temporarily barred a local supplier from using a mark found deceptively similar to a well-known ayurvedic brand, holding that the adoption appeared misleading and capable of confusing consumers. The Court restrained manufacture, sale, promotion, and any creation of third-party rights during the proceedings.
Source: h7.cl/1l00x
4. The Drug Consultative Committee has noted that some State Licensing Authorities (SLA) are issuing manufacturing licenses for new drugs without prior written approval from the Central Licensing Authority (CLA), as required under The New Drugs and Clinical Trials Rules, 2019. Members unanimously agreed that SLAs must obtain CLA approval before granting any such manufacturing permission.
Source: h7.cl/1g6Xk
5. The United States Food and Drug Administration has reportedly finalized guidance on promotional labeling and advertising for biologics and biosimilars, outlining standards to ensure accurate and non-misleading communications. The document clarifies expectations for data presentation, comparative claims, and identification of products, with specific caution against comparisons that imply reduced safety or effectiveness.
Source: h7.cl/1l00M