A hard drumbeat of U.S. FDA complaints against more than two dozen companies in India for quality violations has affected 39 drugmaking facilities, creating an avalanche of remedial work that could take years and is steadily driving up medicine costs in the United States.
India has deferred planned trade talks with the European Union as a form of protest to a European Union-wide ban set to start this month on more than 700 drugs that were bioequivalency-tested by GVK BioSciences, India's Live Mint newspaper said.
A European Union-wide ban on more than 700 drugs that were bioequivalency tested by India's GVK BioSciences will come into effect on Aug. 21 in a move that New Delhi had tried to head off with diplomatic efforts.
The fallout from a European Union-wide ban on more than 700 drugs that were bioequivalency-tested by India's GVK BioSciences could cost India at least $1 billion in exports by the end of the fiscal year in March 2016, the Economic Times reports.
Repeated quality violations by Indian drug manufacturing and contract research firms are casting a long shadow on the country's hopes to be a key global supplier of medicines and services. And they come at a particularly acute time for Biocon, which opens an initial public offering for its Syngene unit next week.
While the European Medicines Agency said it "does not question that the benefits of HPV vaccines outweigh their risks," on Monday it announced a safety review of the shots that have thus far failed to live up to expectations partly due to safety concerns and a sex-related stigma.
Indian CRO Quest Life Sciences of Chennai saw the results of a clinical trial of HIV drugs rejected by the World Health Organization after an inspection found poor clinical practices on data and bioanalytical procedures that could not be remediated, according to a letter from the Geneva-based United Nations body.
A deal by Sweden's Medivir to trim costs by entering into a partnership for drug research has thrown a bit of support to CRO GVK Biosciences, which faces a European Medicines Agency recommendation for the suspension of more than 700 products tied to its facility in India.
When any member of the European Union finds issue with a drugmaker, it is reported to a central database to alert other members that might also buy from that facility. Now Slovenia has raised red flags about an Indian drugmaker it says it discovered during an inspection is not meeting cGMP standards.
South Korea's Celltrion and Samsung Bioepis are poised to gain new or expanded approval for biosimilars of some of the world's best-selling biological drugs, setting up a regulatory knowledge base on approvals and bringing commercial competition to major drugmakers not unlike that seen by small-molecule generics from India decades ago.