Facing Regulatory Heat, Indian Pharma Turns To Quality Solutions
Against a backdrop of US FDA warnings and global regulatory convergence, the Indian pharma industry is looking to build in quality from project inception and foster an unbiased approach to quality across global markets, a conference in Mumbai hears.
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Indian credit rating agency ICRA has forecast that the country’s pharmaceutical industry will remain on a steady 11%-13% growth path this fiscal year, underpinned by healthy domestic demand, new launches and market share gains.
Risks like highly manual aseptic filling lines, poor root cause investigations and unwritten procedures were examined in Mumbai workshop.
An FDA warning letter issued to Aurobindo highlights recurring failures over several sites, while Teva is setting up a biologics development campus in the US and Nexus is investing in sterile injectables capacity.