India May Take WTO Action after EMA Drug Suspension
India may go to the World Trade Organization if the EU does not reconsider its decision to suspend the sale of about 700 generic drugs that were approved based on clinical trials by GVK Biosciences.
Reuters reports
that India may go to the World Trade Organization (WTO) if the European Union does not reconsider its decision to suspend the sale of about 700 generic drugs that were approved based on clinical trials by GVK Biosciences. EMA's
suspension
became effective in January, a month after France, Germany, Belgium, and Luxembourg suspended the sale of 25 generic drugs that were approved based on trials conducted by GVK Biosciences. Drugs suspended by EMA include those made by US firms Mylan Inc and Abbott Laboratories, as well as large Indian companies such as Lupin and Dr Reddy's Laboratories. After an appeal by the company, the Indian government set up a panel of experts last year to investigate the matter and found no manipulation, GVK Biosciences CEO Manni Kantipudi told Reuters. If the suspension is not reconsidered New Delhi could take action at the WTO.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
