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

Even Smaller Countries Now Question Indian Drug Quality Standard

India has over 135 US-FDA approved pharmaceutical manufacturing units, at present. This number is very significant ranking second behind the United States, and was driving the growth of generic drug exports in the top pharma market of the world. Riding … Continue reading

PE Investment In Pharma: The Changing Need Of Due Diligence

From an international perspective, a Bain & Company report of April 2016 highlighted setting a new healthcare M&A record in the year 2015. During this year the total deal value was over 2.5 times higher than the average annual deal value … 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

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

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

Loss of Ranbaxy, Gain of Big Pharma…And Two Intriguing Coincidences

In March 2014, the largest pharma player of India by market capitalization, Sun Pharma, became the latest of the large Indian pharma exporters facing the US-FDA ‘Import Ban’ for drugs manufactured at its Gujarat-based plant. This news came as a … 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