The Wockhardt management on Monday clarified on the recent USFDA observations for the Shendra facility. The USFDA had made nine 'observations' on Friday highlighting violations of its norms at home-grown drug maker Wockhardt's new facility at Shendra in Aurangabad.
Habil Khorakiwala, Founder, Chairman and Group CEO, Wockhardt, said all facilities were inspected in the past six months and none of the US FDA observations are critical in nature, while adding that all these observations will be resolved in next 2-3 months.In a con-call, he said: "By the time we respond in 15 days, we would have cleared and complied with more than half of these observations and the balance we should be able to complete in another two months or so."
He also added that the company is in 'more intensive' dialogue with the US FDA.In an exclusive interview with CNBC-TV18, Khorakiwala said the Shendra facility is currently approved by the UK and Ireland and products are being manufactured at the facility and supplied to these countries.
Below is the verbatim transcript of Habil Khorakiwala’s interview with Ekta Batra.
Q: Just wanted to clarify these nine observations that you have got, when you say critical and not critical, what do you mean by that. Can you give us more colour on what kind of observations you have got?
A: As I mentioned in the concall that they are not critical and generally there is an understanding of critical which is a showstopper and things like that. So none of them are there and nearly half of them, we should be able to resolve in next 15 days that means we will reply and the balance in next few months, maximum two-three months. Q: Currently this facility is approved by, which other authorities?
A: It is already approved by UK and Irish authority and we are manufacturing the products and supplying to UK and Ireland.
Q: You are already supplying to UK and Ireland from Shendra.
A: Yes.
Q: When you talk about not critical and the fact that you will possibly resolve a couple of these observations in the next 15 days because you are going to respond in 15 days, when do you expect it to be approved by the US Food and Drug Administration (US FDA)?
A: It's difficult for us to comment on it but we do expect resolution of this issue soon enough.
Q: Talking about the Shendra facility, is it safe to say that there were no data integrity issues. I do not know how it works if the facility itself is not already supplying to the US but there was no data integrity issue that was brought up by the US FDA?
A: Yes.
Q: What about the Waluj facility because I heard on the conference call that you said that it is received an establishment inspection report (EIR) from the US FDA. When did that take place?
A: That came some time back.
Q: When is that?
A: I think couple of months back.
Q: So it is fair to assume that your Walunj facility is fully functional and supplying to all regulatory markets including the US?
A: That is not correct. We have not received withdrawal of alert but we are supplying from our Walunj facility from the beginning to the US and that is continuing.
Q: So I am assuming that you got the establishment inspection report after the US FDA reinspected the facility and they said its okay and you have received an EIR but the withdrawal of the import alert has not yet taken place?
A: That's correct.
Q: When do you expect that to take place?
A: I cannot answer that question.
Q: How is the Walunj facility operating for the US right now?
A: We are supplying from Walunj facility to the US.
Q: We had a word with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and they said that it was last inspected in March 2013 and it has not yet been reinspected and it is currently not in compliance?
A: We have not taken away those one or two products for UK from Walunj facility and we are either manufacturing in L1 or other facility.
Q: What is the status between Chikalthana and US FDA?
A: Same situation. After inspection we have not heard from them and we are initiating a dialogue that we hope that we will have a better understanding of our status soon enough.
Q: Considering that Wockhardt has had so many regulatory issues in the past couple of months since 2013 especially. Do you think that it is prudent call for the management to possibly come out with the fact that there are some observations which have been undertaken by the US FDA and to clarify to investors about how severe or not the observations are. Do you think that that's something that the management can do going forward?
A: I didn't understand the question but what you mean is the way I am clarifying is appropriate. However, I must say if it was not appropriate, I won't be talking.
Q: Can you give us growth guidance in terms of other markets. What are you expecting for India, emerging markets as well as the other markets that you are supplying to ex-US?
A: Other than US market, our current business to India, emerging market collectively, we have 20 percent plus growth and we believe that we should be able to maintain that kind of level of growth.
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