U.S. & EU Regulators Urge Indian Drug Companies to Step Up Standards

“Data integrity really sounds off alarm bells for us … if you see data integrity on the surface, there is likely a lot going on underneath,” Cosgrove said.

The regulators said that it was critical that Indian companies ensure they follow quality standards, especially as they aspire to make original medicines and more complex products, such as biosimilars.

“Generics is only one part,” said Shanghvi, whose Sun is also the world’s fifth-biggest generic drugs maker. “We need to think about how we can transform into global players.”