Rubbishing concerns that the increasing FDA scrutiny of Indian pharma companieswas a case of "irrational clampdown", Biocon CMD Kiran Mazumdar-Shaw told CNBC-TV18 that the US regulator is mandating more stringent norms for companies across the world.
"It is raising the bar. Indian companies will have to meet them. It is a matter of time they will meeting the high standards that are being set," she said.
The FDA's frequency of audits was becoming more frequent and it was world-wide phenomenon and not restricted to Indian companies, she added.
In the interview with Latha Venkatesh and Sonia Shenoy, Shaw also outlined the company's business outlook.
Below is the transcript of the interview on CNBC-TV18.
Sonia: What is your assessment of what is happening with the US FDA's observations on Indian pharmaceutical companies? Is it that the quality control problems have increased with the Indian companies or is it just an irrational clampdown by the US Food and Drug Administration (USFDA)?
A: I do not think it is an irrational clampdown because US FDA is extremely responsible in terms of its audit processes. The stringent norms that US FDA is now mandating across the world is raising the bar and Indian companies have to start focusing on meeting these norms and this is a matter of time before all Indian companies will be able to comply with the very high standards that US FDA is setting the world over.
I can tell you that (Form) 483s are becoming quite rampant, not just in India but across the world and in fact many US companies have also received similar 483s and even warning letters but when the optics is on India it gets amplified but this is something that Indian companies have to invest and spend much more in terms of their quality systems than they use to in the past and the frequency of audits is becoming far great than it use to be in the past. So this is where Indian companies have to be on their toes.
Latha: Do you see that process under way? Do you see the professionalism coming in or coming in very soon?
A: I think Indian companies have already displayed leadership in the generic space and we certainly must keep strengthening that leadership position. I believe that we have the capabilities and we have all that it takes to keep strengthening that leadership but today the focus and effort that is needed to make sure that we stay ahead is much greater than before. Therefore, I do believe we have all that it takes.
Latha: I mean specifically with respect to 483s.
A: This is an area which is now fairly kind of becoming quite a normal kind of event and that is something which we need to prevent. I think this is where a lot of Indian companies do need to invest a lot more in their quality systems than they used to in the past. I am sure this is happening because no company wants an alert on its manufacturing facility because India is sort of pharmacy of the world and we cannot afford to let these kind of 483s hamper our ability to export.
So, I think companies are very aware of it. I know that there is a lot of effort of bringing in consultants to make sure that they comply with these rising standards. It is only a matter of time, I am very confident that just like other US companies are getting over these hurdles and humps, I am sure Indian companies will do likewise.
Sonia: What are the revenue triggers for Biocon itself over the next three to six months?
A: We have bet very big on biosimilars. We have a very interesting and growing pipeline of biosimilars and many of these are advancing very rapidly in the clinic and whilst the regulated markets open up to us by the end of 2016 onwards, there are some very interesting opportunities for us to play in the emerging markets.
So, I think these are big opportunities for us. Our insulin's are also going to be very important so basically we are betting on this and we are betting on our historic businesses but these are the main triggers and we believe that this is a very exciting and a huge opportunity to play in.
Latha: I wanted to ask you specifically with respect to your oral insulin Alzumab. Are you monetising it anytime soon?
A: In terms of oral insulin, there is some important clinical data that has to be received by the end of this quarter and once that happens that opens up a very interesting opportunity. It's already partnered with Bristol-Myers Squibb, so that allows us to look at the next part of monetisation for that asset.
In terms of Alzumab or Rituximab, we have hit a bit of a hurdle because of the Cuban origin of this particular drug and therefore we are looking at addressing some of these issues which can free us of this particular challenge, but otherwise the drug itself is great, its doing well and we have a huge opportunity and so therefore once we clear these hurdles we will be able to monetise it attractively.
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