For Improving Drug Quality in India – A Bizarre Intent

On January 16, 2017, quoting a Government source, a media report revealed, “India’s drug regulator is looking to inspect US pharmaceutical facilities, making critical medicines so that only high-quality products are imported from them.” This intent follows a similar decision … 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

Ease of Doing Pharma Business in India: A Kaleidoscopic View 

Ensuring ease of doing any ethical business activity in India, is a new focus area of the Government and is very rightly so. Creating ease of doing ethical pharma business too, falls under this overall national objective. In this article, … Continue reading

3D Printing: An Emerging Game Changer in Pharma Business

On August 3, 2015, Aprecia Pharmaceuticals in the United States took a game changing step towards a new paradigm of the global pharma business. The Company  announced that for the first time ever, the U.S. Food and Drug Administration (US FDA) … Continue reading

Data Manipulation: Leapfrogging Dangerously Into Clinical Trial Domain

Over the last several years, repeated allegations of gross data manipulative practices, detected by global drug regulatory agencies, such as USFDA and MHRA, have shaken the Indian pharma exporting companies hard. This has been hurting the overall business performance of … 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

Pharma FDI Debate: Highly Opinionated, Sans Assessment of Tangible Outcomes?

In 2001, the Government of India (GoI) allowed 100 percent Foreign Direct Investments (FDI) in the pharmaceutical sector through automatic route to attract more investments for new asset creation, boost R&D, new job creation and ultimately to help aligning Indian … Continue reading

After Mollycoddling China Cracks Down on Pharma MNCs…But Why Now?

In tandem with exemplary growth in the healthcare sector, China has started confronting with some consequential hazards in form of serious regulatory violations involving, besides many others, hospitals, pharmaceutical pricing and food and drug safety, which reportedly include contaminated milk powder and … Continue reading