Another nano controversy

NatcoI must admit that when I read a report about the recall of breast cancer drug Albupax for the presence of more-than-permissible levels of endotoxins I was moved to wonder aloud how such a product could have been approved in the first place. (See my tweet). Well, I may have overreacted.

From what I gather, there’s more to this recall than meets the eye.  We don’t know for instance whether CDL in Kolkata which tested the product – a nanoparticle albumin-bound version of old chemotherapy drug paclitaxel – used the same method as the one used by the company – a question that has been raised by Natco. I am given to understand that the CDL is a bit behind the times in its sphere of activity. One CEO – unconnected to Natco – tells me that it is known to borrow equipment from companies to test their products! So there may be some truth in Natco’s contention that the testing was all wrong since I am given to understand there was no borrowing of equipment this time.

Two, such a problem usually creeps into the manufacturing process and is not inherent to the product. Injectible manufacturers are required to routinely inspect samples from every batch to test that endotoxins – released upon bacterial degradation -are within limits.  If endotoxin levels were high, then it would likely have been detected by the quality boffins in the factory.  But nowhere has the DCGI indicated that the company wilfully put contaminated samples into the market.

I also find it difficult to believe that it has. It would be far less damaging for Natco to quietly recall a tainted batch than to wait for the DCGI to discover it on the market and cancel its licence. Besides, Albupax  has not performed upto expectations since it is far more expensive than the ordinary paclitaxel. All of 15 people have taken it. It is really difficult to believe that Natco would take such a big risk for such a small product.

However what really makes this whole recall seem not quite kosher is the way it happened.  The DCGI initiated its inquiry after Abraxis BioScience, the company that makes the original Abraxane -of which Albupax is a legal copy or generic – complained. It turns out that Abraxis got its Indian marketing partner Biocon to pick up samples of the drug and parcel them off to the US where it got the samples tested.  It then complained to the DCGI who sent the samples to the CDL for testing.  The rest, as they say, is history.

I have drawn several inferences from this. One, clearly some innovators are getting aggressive about protecting their turf. Abraxane is a big product for Abraxis – in the fourth quarter of 2008 it was $90mn of the $92 mn net revenues of the company, most of it from the US.  And Natco’s end-goal for Albupax is the US where patents on Abraxane expire from 2013 onwards.  So Abraxis clearly wants to nip that in the bud or at least postpone it as much as possible. Also, India finds mention as one of the new geographical opportunities that Abraxis is trying to open up for its product in a recent press release.  Cheaper competition, of course, queers the pitch. And Natco not only had a cheaper generic on the market, it also had opposed Abraxis patent applications before the Indian Patent Office.

What concerns me also is the way industry executives that I spoke to dismissed the CDL which is our apex drug testing laboratory as inept and ill-equipped. What credibility then should one attach to its activity. Now, if readers recall, the US FDA has opened its office in India to be closer to the manufacturers who sell into that country.  I wonder what they have to say about our testing infrastructure.

Lastly, the DCGI needs to get more transparent. When the FDA pushed for a recall of Ranbaxy’s gabapentin in the US one knew more or less the severity of the problem from the FDA website (there are various classes of recall indicating their severity and whether the product endangers the health of those taking it).  Here we know nothing frankly. Just that were some endotoxins – make of it what you will.  And that too we know this from a business newspaper, not from the DCGI website. If there was a problem, doctors and patients as well as the general public need to know what it was, and its severity.

Surely, points to ponder over.


One thought on “Another nano controversy

  1. Gauri,

    Completely agree with your views on the DCGI’s role.

    With so many training sessions that the DCGI officials are having with the U.S. FDA trainers, one lesson on accountability and transparency may be included.
    Since the same regulator approved Natco’s product, questions should be raised on the parameters being followed when giving new drug licenses.
    The DCGI, therefore, has no moral right to plead for a central drug authority and try to score over state FDAs, when it is itself not any different.


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