Monday, April 14, 2014

Lupin's turn

In this post, I predicted, "As FDA scrutiny of Indian generic manufacturers increases, we can expect many more such headlines to be made", in reference to Sun Pharma joining the list of companies whose generic drugs failed USFDA quality control standards.

Just call me Nostradamus, because Lupin Ltd. is the next generics manufacturer to fall foul of the FDA.  The company's US arm, Lupin Pharmaceuticals Inc, voluntarily withdrew nearly 10,000 bottles of the branded antibiotic Suprax (cefixime). Much like in Sun's case, the company claims that this is a "voluntary recall" which is of "no business consequence". Lupin also withdrew over 64,000 bottles of the drug last year, due to problems with discoloration.

Again, taken in isolation, the incident may indeed not be of much business consequence. But as pointed out on Fierce Pharma
"The laundry list of product bans, FDA warning letters and recalls at Ranbaxy and its Indian rivals have prompted new scrutiny not only by regulatory agencies around the world, but by pharmacology experts who worry that Indian-made generics aren't as effective as their brand-name counterparts." 
That is very bad news indeed for the Indian generics industry, and for drug development in India as a whole. There are companies who use the revenue generated from their generics business to bankroll their research operations. Generic drug manufacturers are also helping to build a pool of experienced pharma professionals in India, who could presumably apply their knowledge to developing new drugs as well. Cleaning up these negative perceptions is going to be a Herculean task, but one that all players in this market need to do in good faith if they plan to stay in business, not just to make money in the US market but to help drug discovery take root and flourish in India.

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