Ranbaxy's US FDA ordeal may take over one year to resolve

The ongoing tussle between the US FDA and Ranbaxy is far from over and so are the worries of the company's stakeholders. Experts say it may take over an year for any resolution to come. CNBC-TV18's Sriram Iyer reoprts.

Ranbaxy is going through US FDA's Application Integrity Policy Audit -- a process of investigating alleged falsification of data.  

Of the 18 companies which went through the AIP audit, five of them shut down. And, three other companies, for whom data is available, it took about 26 long months to come clean.  

How it works

Ranbaxy has to undertake third party independent audit of applications submitted from its Poanta Sahib plant. This will be followed by an FDA inspection, and only after can the AIP be revoked.

More importantly, there cannot be partial revocation, which means Ranbaxy has come clear in every data on every drug that has been questioned by the FDA.

Experts also say greater damage may be caused other regulatory agencies taking actions in line with the USFDA. This could affect the company's other international markets. According to sources Ranbaxy has already stopped shipping products from the Poanta Sahib facility to Canada at the behest of the Canadian Regulator. So it may be a while for Ranbaxy to come clean.

Also see: US FDA says Ranbaxy falsified drug application data