Need to be watchful of FDA import alert pattern: Dandekar

The US drug regulator FDA issued import alert on drug-maker Wockhardt's Chikalthana plant, citing non-compliance with good manufacturing practices.

Commenting on the import alert, Vikas Dandekar, India bureau chief, Pharmasianews.com said it will not be easy to come out of such sanctions. It will take a year or more for the company to restore manufacturing practices and to get a green signal to export some of these drugs back to the US. Dandekar is surprised at the absence of stringent domestic regulatory actions against the companies facing import alerts from US and UK regulators After the crippling blow, it remains to be seen if the USFDA follows the defined steps before issuing import notices or will they skip steps to showcause non-compliant companies. Below is the verbatim transcript of his interview on CNBC-TV18 Q: Is Wockhardt the new Ranbaxy? A: Reading the warning letters that had come to Ranbaxy years ago and when we saw the same thing happening with Waluj in September, these are very grave concerns that have been voiced by the US Food and Drug Administration (FDA) and it looks a repeat of what played out with Ranbaxy. Repeatedly, we have been seeing data integrity issues coming up, inaccuracies in the way processes are handled. In terms of deviations these are some things that does raise a lot of question on the way the culture of manufacturing compliances are being followed. It looks like it is almost the same things that have been happening with Ranbaxy, it just keeps coming back becoming bigger. Q: Would you go as far as to say that it is nail in the coffin for Wockhardt or you think that they can come out of this? A: One thing that goes with the USD FDA is that they do give a long rope and ensure that flexibilities have been provided. So first, they will give the observations on Form 483. Then they will issue warning letter and finally it goes to slapping import alert. But then in exceptional cases we have been seeing companies getting served import alerts directly. So it is forming an opinion that the perception is definitely going down in terms of the way manufacturing has been used in the Indian context. It is not just about the Indian generic companies, we have known about global companies, Fresenius Kabi and Hospira have also seen same kind of fate in terms of FDA inspections. They have also been served warning notices. Coming to Wockhardt, the point that comes to mind is will there be enough alternatives? Are these sites being used in the same way, or quality controls in all of these companies have some lapses? With the kind of crippling blow that has come with this particular import alert is definitely shattering. So one will definitely have to be much more cautious on the way US plans are shaping up. Q: What do you expect now the company could do because comparing with Ranbaxy even Ranbaxy is not able to stand on its feet after big blows coming in from US FDA and do you see any revival for Wockhardt in the next one-two years or even more than that? A: Depends on exactly how they fall in line with the compliance practices. Earlier in this year Dr Altaf Lal took office as country director of FDA in India and he has extended a very clear picture in terms of working closely with the Indian regulators, with Indian companies trying to understand what kind of preventive controls can be ensured so that Indian companies become more aware of the risk policies that are there with the FDA, and not just the FDA, even the UK Medicines and Healthcare products Regulatory Agency (UKMHRA) or other regulators. So sooner the better if Indian companies understand exactly how the world compliance issues are shaping up. I don't think it will be a very easy exit or to have quality controls back in place because now the rigors are becoming stronger. We have seen some examples of companies coming out of these deviations and manufacturing practices getting restored but it is going to be a pretty long haul. _PAGEBREAK_ Q: Most of the analysts whom I have been speaking to point out that the international business of the company will get suffered out of all the questions raised by USFDA and UK-Medicines and Healthcare Products Regulatory Agency (UKMHRA) but it is only the domestic business which is still intact for what they are valuing the business. Do you see any risk on the domestic business also coming up post announcements coming from both the overseas regulators? A: That is a fair question. In fact, I have not seen any stringent regulatory action coming from Indian regulators on any of these companies and we are talking about the iconic names in the India like Wockhardt, Ranbaxy - all of these companies are the best players so to speak and have been known the way they expanded aggressively in international markets. Indian regulators probably will have a lot to do in terms of the way good manufacturing practices (GMPs) are managed and inspected. A lot is left to be seen on exactly how these things reflect on the Indian regulators and what are the things that they are going to be learning from their international counterparts. Q: Will it take many months for Wockhardt to be able to restore manufacturing practices and get a green signal to export some of these drugs back to the US? A: Absolutely because this is going to be very long, we don't see companies coming out of import alerts very easily be it international, Indian. For global companies, innovative companies - import alerts are definitely not something that the company would like to be in that kind of a position. So, all of the processes will have to be reviewed. Wockhardt itself has made announcements that they have actually taken help of international consultants. So it is a pointer that it is not going to be a very easy task. It will take at least a year that will be the safest bet so it will be upwards of a year at least. Q: And they cannot farm out production to other plants or other companies? A: Yes, because that will have to be site-transferred, a lot of resubmissions will have to be done and again the whole process will have to be reinitiated. So that is not a very easy route as well. We have seen companies - Lipitor in the case of Ranbaxy did actually move to Ohm Laboratories from their Mohali unit but that again takes a long time and it will definitely not be a fast-track treatment the way Lipitor had been given.