After a series of bad news hits from the US, India's generic drug makers have finally had some good news. The US Food and Drug Administration (FDA) is coming out with clear guidelines for clearing complex generics. Ordinarily these are difficult to copy, and consequently exorbitantly priced. A recent review by the agency promised to come up with clear guidelines on scientific data and regulatory guidelines on complex generics.
This is good news for Indian companies such as Sun Pharma, Lupin and others who are migrating to complex generics, branded specialty drugs, and reverse engineered biotech drugs or bio-similars.
Of late, Indian companies are migrating to high value generics with less competition, instead of selling large volume low value simple generics. The FDA move will expedite approval for pending marketing applications and can give directions to ongoing research and development programmes.