Pharma cos have increased focus on quality controls: Biocon CMD

A facility of biosimilars firm Biocon has cleared inspection by the US FDA, Kiran Mazumdar Shaw told CNBC-TV18, even as she termed the development as a routine matter."We recieve periodic inspections several times in a year from both the FDA and other regulators, which is bound to happen," she told CNBC-TV18. "We are pleased that we have a strong track record with the FDA."The unit in question that got FDA approvals manufactures statins.The pharma industry has been a bit under the cloud over the past many years, with a number of Form 483 (observations over non-compliance) and even warning letters that have led to import alerts coming through for some plants.Of late, however, the spate of regulatory issues seems to coming off finally.But Shaw said that observers should differentiate between Form 483, which can be easily rectified, from warning letters."The media should not focus so much on 483s," she said, though she maintained that the pharma industry had indeed increased controls on quality.Below is the verbatim transcript of Kiran Mazumdar Shaw’s interview to Ekta Batra & Anuj Singhal on CNBC-TV18..Ekta: We are picking up from our sources that indeed Biocon has one of their US Food and Drug Administration (FDA) facilities or one of the facilities cleared by the US FDA in a recent inspection. Can you just firstly confirm that news for us and how important that facility would be in the larger scheme of things?A: I can certainly confirm the news but these are very periodic inspections that we receive. So, it is not something that is particularly that we can talk about because we receive periodic inspections from regulators which is bound to happen in our industry. So, of course we have been inspected by US FDA several times over the last one year like we have been inspected by many other regulators.So, as far as we are concerned quality compliance is an extremely important aspect of our business and we have a very good track record with all the regulatory agencies around the world. So, of course this is one of the many sort of US FDA inspections that we have undergone and we are very pleased that we have a very good track record with US FDA.Ekta: There is a larger picture which seems to be emerging however within the pharma industry. Say, a few months ago we were talking about how there were rampant US FDA inspections that seemed to be going wrong and there were multiple 483 and there were some warning letters that were issued for bigger plants as well. But now there seems to be a bit of a turnaround with many of the companies receiving establishment inspection reports or no 483s in their inspections or minimum 483s. Do you then assume that maybe we have crossed over that hump or that bad patch that we went through a few months ago?A: I want to take this opportunity of basically educating the media and people at large about quality compliance. We must learn to differentiate between warning letters, warning letters that result in import alerts which is very serious and 483s. 483s is just about non-compliance which can be rectified very easily. This perception that 483s are something to really worry about is something that needs to be understood better. 483s are non compliances which can be rectified easily and that is not something that is really of great concern to companies. What is of concerns of course are warning letter.So, I would like media to report warning letters and more importantly warning letters that lead to import alerts which is really very serious. Please don't keep reporting 483s because 483s are not of big concern to the companies. And I can tell you that yes, Indian companies are beginning to turn the corner because there has been a lot of emphasis on getting into quality compliance and quality inspections in a much better way. So, you are seeing improvement in this kind of issue. But I would really like you to make sure that you don't keep focusing on 483s because 483s are part and parcel of inspection.Anuj: The other issue has been - and we have discussed this earlier. In January your compliant was that the market does not realise or CLSA in particular did not realise the true potential of your business. Your stock has been a rank outperformer ever since that Japanese approval. So, from markets point of view in terms of opportunity going forward. What kind of opportunities exist for some of your blockbuster drugs going forward?A: I am in the silent period so I should not be giving you any forward looking statements at this point in time but generally you know that biosimilars offers a huge opportunity especially for companies like Biocon where we are in the first wave of biosimilars companies going forward in markets. That really is the opportunity for Biocon which you are seeing is being recognised and realised because we have announced that we will be making several filings in US and Europe this fiscal. So, that is what is basically being very well received. But other than that I don't think I can make any more statements because we are in the silent period and it is only next week that you have to wait for till we make certain announcements. So, at this point in time I don't think I would like to make any further statements on our business.