FDA regs might hurt Indian pharma companies

India's drugmakers will have to grapple with 17 new FDA recommendations for developing oral medications for type 2 diabetes, likely costing the companies more time and money to obtain regulatory approval. The companies include Biocon, Dr. Reddy's Laboratories, Glenmark Pharmaceuticals and Piramal Life Sciences. In addition to following the new recommendations, the companies will have to show that their offerings do not increase heart-related complications.

There have been multiple regulatory and medical warnings regarding cardiovascular risk for type 2 diabetes medications already on the market, including rosiglitazone. The new regulations will cause delays bringing new drugs to market. For instance, Dr. Reddy's is developing the diabetes med balaglitazone, which it hopes to market by 2011. Back in 2004 Danish pharmaceutical company Novo Nordisk halted all development of the drug because it was it wasn't able to show a competitive advantage over medications currently on the market. "DRL has known for a few years now that its drug candidate balaglitazone is not very promising. But it has tried to hide this fact and gone ahead with developing the drug," says an anonymous source. "They are most likely to suffer under the new recommended FDA guidelines."

Mary Parks, director, division of metabolism and endocrinology products at the CDER, said in a press release that the FDA would need to understand the safety of new medications for diabetes more clearly. "Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage."

- read the full story at Live Mint