Blockchain: Pharma Keeps An Eye On The Ball

On April 24, 2017, The Wall Street Journal (WSJ) came out with an interesting headline, “Dubai Aims to Be a City Built on Blockchain.” Some may have taken note of it seriously. However, a vast majority of its readers possibly … Continue reading

Clinical Trials: Critical Need To Improve Patient Participation With Informed Consent

On April 13, 2016, an article in the Wall Street Journal (WSJ) titled, “Clinical Trials Need More Subjects” underscored an important point that the rate at which the clinical researchers are able to recruit and retain patients for ‘Clinical Trials … Continue reading

The Curious Conundrum of New Drugs Approval Process

Fathoming the details of just a short span of time, not going beyond the last 10 years, I find from the published data that many new drugs, such as, Alatrofloxacin, Aprotinin, Drotrecogin alfa, Lumiracoxib, Propoxyphene, Rofecoxib, Rosiglitazone, Sibutramine, Tegaserod, Tetrazepam, were … Continue reading

‘Repurposing’ Older Drugs: Has The Process Started Rolling?

On October 22, 2015, BBC News reported, “The world’s largest clinical trial to examine whether aspirin can prevent cancers returning has begun in the United Kingdom (UK).” About 11,000 people, who have had early bowel, breast, prostate, stomach and esophageal cancer … 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

Pharma Outlook 2015: A Glimpse Of Some Drivers and Barriers

Looking ahead, the brand new year 2015 appears quite interesting to me both from the global and also from the local pharmaceutical industry perspective. In this article I shall try to give a glimpse of some of the important drivers … Continue reading

“Make Global Pharma Responsible in Homeland for Objectionable Conduct in Clinical Trials Elsewhere”

In the context of his recent meeting with Commissioner Margaret A. Hamburg of US-FDA, the Drug Controller General of India (DCGI) reportedly expressed his concern to ‘The Economic Times’ on the ‘objectionable conduct’ of global pharma in new drug trials … Continue reading

New Clinical Trial Regime Deserves Support, Sans Threats

Recent Supreme Court intervention compelling the Union Government to enforce stringent regulations both for approval and conduct of Clinical Trials (CT) in India, has unfortunately met with some strong resistance with stronger words. Some of these voices are from credible … Continue reading