Improving Patient Access To Biosimilar Drugs: Two Key Barriers

Novel biologic medicines have unlocked a new frontier offering more effective treatment for a host of chronic and life-threatening diseases, such as varieties of cancer, rheumatoid arthritis and diabetes, to name just a few. However, these drugs being hugely expensive, … Continue reading

Reticence Around Unveiling Clinical Trials

While scanning through various publications, we now get to know, almost at regular intervals, about new clinical trials capturing the newer ways of treating different ailments. Such information instils an invigorating hope in the minds of doctors and the patients … 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

Nutraceuticals: A Major Regulatory Step That Was Long Overdue

Currently in India the nutraceutical products segment, with surrogate or off-label therapeutic claims, is growing at a reasonable pace. Many such products are now being directly promoted to the medical profession, just like any other modern medicines, with therapeutic claims … 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