Tuesday, April 21, 2009

FDA getting alert or Indian pharma giants getting lazy -

September 08 - Ranbaxy's PAONTA SAHIB & MANESAR mfg unit were under the FDA scan & 30 drugs banned in US .

October 08 - Sun Pharma's Carcao mfg. unit ( Detroit ) - was the victim of FDA rage .

April 09 - Cipla has been questioned for deviation from US FDA mfg. process .


all these incidents raise an alarm - India Pharma giants taking it lighlty or FDA got over concerned.

the point is , it took us ( India) - to build an image of quality drug maker in an economical way - such incidence or black stars from top regulatory agencies pose a serious threat for the future business .

where the major chunk of business for all the top 10 pharma giants of India comes from US , EUROPE - any such decision for not meeting up the standard even after running US FDA or UK MHRA apprved facilities questions the "QUALITY" part of the business .

and one thing to note is that "THIS INDUSTRY IS NOT IN A BUSINESS OF MERE PHARMACEUITCALS , ITS IN THE BUSINESS OF "LIFE & DEATH " - & hence the question on "QUALITY" is not acceptable at all .

when the players like Ranbaxy , Cipla & Sun whom we consider as the torch bearer of the Indian Pharma business display such act of Vandalism , then what we can expect from rest of the industry who wants to follow the footprints of such Pharma Pharaos -

1 comment:

  1. The million dollar question is - is there a possibility that these queries are raised because indian pharma giants are spreading their wings in US? Ranbaxy got a clearance from EU / Australian authorities last month. And my personal experience with MCC says, they are more stringent for outsiders than they are on home industries...
    conspiracy theory? Having said that, I do not condone such " acts of vandalism" as you put it. ;)
    DK

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