A New Facet of ‘Data Integrity’ With Novel Therapy… And Much Beyond

The peril of breach of data integrity involving a top Indian pharma player, jolted many, probably for the first time, on September 17, 2008. On that day, the USFDA, reportedly, issued two ‘Warning Letters’ and an ‘Import Alert’. These were related to … Continue reading

Pharma Governance Maladies and Corporate Leadership

On September 26, 2017, two media headlines related to the Indian pharma industry, possibly made many wonder – Are these some of the key reasons prompting the Government to enforce stringent and costly regulations in this sector? Above revelations came … Continue reading

“Make in India” Image of Pharma Needs An Early Makeover

“It is never too late to be what you might have been” - George Elliot The chronicle of events since the last couple of years or so, related to ‘Make in India’ image of the local drug industry, have been instrumental … Continue reading

“Make in India…Sell Anywhere in The World”: An Indian Pharma Perspective

In his Independent Day speech from the ramparts of the Red Fort on August 15, 2014, Indian Prime Minister Modi gave a clarion call to all investors of the world, “Come, make in India”, “Come, manufacture in India”, “Sell in … Continue reading

Gilead: Caught Between A Rock And A Hard Place In India

I had mentioned in my blog post of August 4, 2014, titled “Hepatitis C: A Silent, Deadly Disease: Treatment beyond reach of Most Indians” that in line with Gilead’s past approach to its HIV medicines, the company would offer to … Continue reading

Moving Up The Generic Pharma Value Chain

June 2014 underscores a significant development for the generic drug exporters of India. Much-delayed and highly expected launch of generic Diovan (Valsartan) is now on its way, as Ranbaxy has reportedly received US-FDA approval to launch the first generic version of this blood pressure drug … Continue reading

Big Pharma’s Windfall Gain From Indian Pharma’s Loss, Costs American Patients Dear

According to US-FDA, its ‘Import Bans’ on quality grounds of the drugs manufactured at various Indian facilities, such as, Ranbaxy’s Paonta Sahib, Dewas and Mohali and Toansa plants, were reportedly solely directed at negating the health safety risks of American patients … 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