This morning’s Indian Express op-ed page carries my views on the impact of the Ranbaxy revelations on Indian generics. To read click here. Just to clarify, I had attributed numbers on US imports of bulk drugs and finished medicines that I have cited in the column to Fortune magazine. The attribution appears to have fallen victim to the editing process so I thought fit to mention it here.
Pic sourced from http://www.ranbaxy.com
Apothecurry 
Gauri,
You have brought out the right perspective. while we know that the business impact may not be immediate but the indian pharma companies need to understand the depth of this issue and ensure ethical and quality practices are followed to the core. Ranbaxy undoubtly has brought Indian Pharma to global attention but also with this episode has brought it down in quality and reputation also. With such issues the scrutiny from the global regulatory agencies will only increase and the indian pharma companies need to be prepared for it. The only answer to that can be best ethical business practices and that only can sustain or rebuild the reputation and the business.
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Most Indian Pharma Companies have standards way below accepted International standards. The problem is the dichotomy of implementation – State vs Center! Why cannot we raise our voices for the Indian patient and demand the same uniform standards – not just at Ranbaxy but at ALL pharma manufacturing units?
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Gauri, You & I both know the fragmented Pharma manufacture that is current in India due to varying standards in different States of India. Is the US patient’s health much much more important than that of an Indian patient? surely not! Then why don’t people, like yourself, with some power of persuasion write about the need for uniform high standards of Pharma in India. There must be a hundreds of units making drug products that are way below the standards of Ranbaxy. Two wrongs don’t make a right but let us all together right the real wrong – our standards!
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Gauri
As always I appreciate your thoughtful insights and I agree with the previous comments that have been posted. Two items bear mentioning for clarification. The first is the fact that North American based pharma companies endure and comply with FDA inspections that occur at three to five times the rate of FDA inspections in India. This is a very sore point amongst both generic and innovative manufacturers in North America and may soon become a sore point with American consumers It also renders meaningless a comparison in the number of citations for violations between India and Canada and US manufacturers.
Secondly there is no question that generic medicines save American consumers billions of dollars. Generic medicines are perhaps one of the greatest legacies of pharmaceutical research and development. According to IMS over 90 percent of Americans will switch to a generic when one is available – because they have confidence in the regulation and oversight of products approved for sale in the US. But it is incorrect to say the price drops 90 percent when a generic debuts in the US. In fact the FDA grants the first entry generic six months of market exclusivity in the US at a price that can be as high as 75percent of the originator product. Indian companies are aggressive at taking advantage of this windfall. Hence Ranbaxy sold $ 600 million in generic Lipitor with first to market entry but this dropped to $60 million when the six month exclusivity expired.
Regardless India needs to take very seriously the extent to which the Ranbaxy fiasco will alter the perception of the India Pharma industry. It would be folly to underestimate the impact that this sad situation will have on consumer confidence in even those companies in India that operate to the highest standards. The more US consumers know about the chaotic regulatory system in India the more they will start to demand transparency on where their medicines originate. India needs to be seen to take these issues seriously but the pattern of regulatory reform in India is that when there is a crisis: find a scapegoat (preferably foreign) and reform can then be avoided.
Gauri keep pushing for a world class regulatory system in India
Chris Ward
Sr. Partner, World Health Advocacy
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