A ‘Toxin’ Delaying Success of Biosimilar Drugs

The above comment, although sounds a bit harsh, was made recently by none other than Scott Gottlieb - the Food and Drug Administration Commissioner of the United States. He expressed his anguish while explaining the reasons for a delayed launch of several important … Continue reading

Drugs From The Same Indian Plant: Safe For Europe, Unsafe For America, Why?

Good number of stories on US-FDA banning several drug manufacturing facilities of major domestic players of India over serious quality related issues, have been doing the rounds since about a year and almost at a regular interval. The quagmire has … Continue reading

Does India Believe in Two Different Drug Quality standards?

“Maintain and sharpen your intellectual honesty so that you’re always realistic. See things as they are, not way you want them to be.” The above profound statement is what the Management Guru Ram Charan made in his book titled, ‘Execution: … Continue reading

The Takeover Magician To Tango Again On A Bold New ‘Sunny’ Tune

The consolidation process of the Indian pharmaceutical industry continues in its own pace. Most recently, the homegrown pharma takeover magician is all set to tango yet again with a bold ‘Sunny’ tune. The low profile creator of high value ‘Sun … Continue reading

Is Credibility Erosion of Pharma Accelerating?

‘Big Pharma’ now seems to be desperately trying to gain the long lost high moral ground by pushing  hard its gigantic image makeover juggernaut, maintaining a strong pitch on the relevance of stringent Intellectual Property Rights (IPR) in the lives … Continue reading

Threats to Indian Generics: Failing in US Inspections is Just Half The Story

At a recent event of the American Enterprise Institute, Dr. Harry Lever, a senior cardiologist at the Cleveland Clinic in Ohio, reportedly expressed his concern based on his personal experience regarding inconsistent quality among Indian generics. As a result, he requires switching patients … Continue reading

Are We Taking Safe and Effective Medicines?

The above headline is in no way intended to mean that this discussion is on spurious or counterfeit drugs. Today’s deliberation is on the licensed drugs, which are manufactured in India, for the patients of the country, by the manufacturers … Continue reading

USFDA ‘Import Bans’: The Malady Calls For Strong Bitter Pills

It is a matter of pride that Indian pharmaceutical industry is the second largest exporter of drugs and pharmaceuticals globally, generating revenue of around US$ 13 billion in 2012 with a growth of 30 percent (Source: Pharmexcil). Though sounds awkward, … Continue reading