Talking to ET Now, Amit Rajan, MD, Prosfora Tech, says Sun Pharma’s oral approvals technically will start from next month itself.
What do you make of the observations on Sun Pharma’s Halol plant because prima facie they do not look critical in nature?
We talked about Sun Pharma 18 months ago and I had predicted that it will take Sun Pharma time to get away from a PMS and it is exactly 18 months now and Sun Pharma is now heading towards the approval. Now, the three takeaways from this secondary inspection are; a) there will not be a re-inspection of the site at all. So, there is no data integrity issue. If you have a big sterile plant like this, you always get observations and these observations are expected. b) It will be a double bonanza for Sun Pharma. Although people are focusing only on steriles, but since the quality management system at the site is both for orals and steriles, ANDAs of both orals and injectables, which are on hold, will start getting approvals one by one. c)The best thing is that Sun Pharma’s ANDA – have three minor deficiencies and the review will start from the site pending the GMP approval. So, it is mostly good news for Sun Pharma.
However, there is bad news for Aurobindo Pharma because Aurobindo had a sterile plant and the observations have not been good. We have to see how much time they take to improve but I very clearly expect Sun Pharma to have a GMP approval in three months’ time.
What about Auro Pharma because the Unit 4 also had three observations which were not critical in nature? The Unit 12 as well is under inspections right now and it is their second largest injectable unit. How critical is this?
The Unit 4 inspection did not go well as you had shared the 483 yesterday. Aurobindo was expected to do good. At Sun Pharma, there were three inspectors for more than 10 days and Aurobindo has been lucky because there was only one inspector for five days actually. So, you can imagine if three inspectors would have been in Unit 4, what could have happened in terms of inspection because inspections do take time, you cannot see all the data in a limited period of time. Now, it needs to be seen how Unit 12 inspection goes off because if the FDA comes out with reading of their Unit 4, 483 Aurobindo has to be careful.
In terms of sterile therapy, India still has to do a lot of things, the FDA’s expectations are increasing day by day.
You said that this is a good inspection for Sun Pharma but let us understand the procedure here. Sun Pharma still has got three observations. They may be minor in nature and till the time those observations are not cleared, they cannot export out of Halol. This means, for FY19, the Halol contribution could only kick in for maximum six months and I am being optimistic here?
Yes. Procedural documentation, communication with FDA, compliance issues…these are the studies which Sun Pharma probably would have started on the last day of the inspection itself. The deficiencies that FDA has noticed on the 483, Sun Pharma probably would have done it or it would be under completion. So, it will take another 15 days to write to the FDA and these are some things which is like a tick box item, you just submit the data and FDA will approve, they are not going to question you further on your data.
One good thing you will see in the inspection and that is what the FDA likes is that one of the observation that FDA made was Sun Pharma had a video recording which was not as per FDA expectation. They asked Sun Pharma to repeat the study in front of them and the study again behaved the same way that was recorded earlier. That imposes a lot of trust on the company. So, even if you are wrong, you are consistently wrong. Based on this confidence, it is just paper work and to answer your question maybe Sun Pharma oral supplies will start because this inspection has no comment on the oral products and so the oral approvals technically will start probably from next month itself.