‘It’s Just Improper Documentation’

Arun Sawhney, CEO and MD, Ranbaxy, spoke to Outlook. Excerpts:

The FDA found irregularities in your Dewas/Paonta Sahib plants....

The FDA has held that the drugs were ‘adulterated’ (as) they did not meet CGMP (Current Good Manufacturing Practice) standards in the US. What had happened was that Ranbaxy delayed testing of stability samples. An incomplete understanding of the word ‘adulteration’ would have caused some to believe that the drugs are not safe, when in fact it was (simply) a question of (improper) documentation. So, CGMP does not, in this case, refer to the quality of drugs.

Without the right manufacturing process, how can the medicines be okay?

I’m telling you there were shortcomings, for instance, that there were no people manning the right positions. However, the drugs are safe and efficacious.

How do we know the past mistakes won’t be repeated?

The executive committee, the board at the apex, both are new (since the settlement). At the apex operational level, all key positions are being manned by people who were not occupying these positions at the time the problems happened.

What are the problems, exactly, that Ranbaxy has sought to fix with its investments of $300 m?

Delayed testing of stability data and und­erstaffing—I recognise these were issues. I want to assure we are addressing them and are on the path to get back in business with the US from Dewas/Paonta Sahib.