Ranbaxy Relief

A nice, if brief, Q&A appeared today in India's Business Standard, featuring a conversation with Arun Kumar, CEO of generics maker Strides Arcolab. The material below is compelling, in light of the opinion of many that Ranbaxy Labs is being made an example of by FDA in order to send a message to all Indian pharma companies regarding the Agency's tougher stance on quality, and the rougher row that all Indian manufacturers will have to hoe in the future.

As a sidenote, the U.S. DOJ today dropped its motion against Ranbaxy, stating that it had received the additional quality-related documentation from Ranbaxy that it had sought.

Now, on to the excerpt:

Q: Do you consider recent FDA action on Ranbaxy a warning for several other Indian companies operating in the regulated market?

Kumar: Yes. It is a cause of concern. If you are an American manufacturer, FDA authorities can come any time and inspect your plant without prior notice. However, Indian firms get a lot more time to prepare for an audit. I think, now there would be a different approach in terms of future FDA inspections to Indian firms — they would be more periodic and highly robust.

Ranbaxy kind of situation is not first of its kind and neither is it unique to Indian firms However, issues with regulatory authorities are changing, and it is not going to be that easy for Indian firms to absorb the blow and go ahead. Our problem in India is we do not have enough talent pool to ensure and raise manufacturing standards.

--PWT