India defers trade talks following EU suspension of GVK Biosciences-tested products
India has deferred its trade talks with Europe following an European Union decision to ban the sale of around 700 pharmaceutical products that had been tested by GVK Biosciences, an Indian contract research organization.
The talks between India’s Commerce and Industry Ministry and the EU regarding the Broadbased Investment and Trade Agreement were scheduled to resume this month, but have now been deferred.
The European Medicines Agency confirmed its recommendation to suspend the drugs, which received their European approval based largely on studies by GVK Biosciences. The EMA said an inspection of the contract research firm’s Hyderabad site revealed “systematic” manipulation of data on electrocardiograms in some generics studies over the past five years or more. The largest suspension of sales and distribution of generic drugs ordered by the European Commission will come into effect on August 21. It will apply to all 28 member nations, according to Germany's drug regulator, the Federal Institute for Medicines and Medical Products (BfArM).
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze