Wockhardt Chairman Habil Khorakiwala speaks with P.B. Jayakumar about the company's recent decision to recall some drugs from the US and how the drug maker is trying to resolve issues related to the US FDA.
Q. What prompted recall of drugs from the US? Is it part of the remedial actions suggested by the US FDA?
A. To make it clear, this is a voluntary recall to speed up the regulatory compliance. The FDA did not raise any data integrity issue or Good Manufacturing Practices (GMP) issues after their recent visit to the Chikalthana plant. They had discussed with us about the products remaining in the US market. We internally and with the consultants did a detailed discussion on those products, considering all aspects including the revenue part. Finally, we decided to recall them as revenues from those are not significant. Standards need to be the same for all plants and that is why we decided to recall over a dozen drugs from both the plants.
Q. Is it part of your strategy to rationalise business in the US, since you have a large number of products in the pipeline for that market?
A. We have been filing products for that market from time to time and the recall is not part of rationalising the business. As I said earlier, it is to speed up the regulatory compliance process. Once the plants get approved, revenues will come from them.
Q. The US FDA is yet to give clearance to two of the plants under its scanner and is yet to inspect the new Shrenda facility. When do you expect these plants to get clearance so that you can normalise business, say within one to one and a half years?
A. One to one and a half years is what you predict, my expectation is much earlier than that. I cannot give a timeline for it, but can say we have done a lot of work with the consultants to ensure compliance and get the plants meet the FDA requirements.
Q. You have some 60-plus ANDAs with the FDA and how many of them are first to file (FTF) opportunities? What kind of revenues you expect from them?
A. As I said earlier, we have been regularly filing new products for the US. I cannot give a number to that.