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
Tag Archives: EMA
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
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
Does India Produce ‘World Class’ Medicines, For All?
India has already achieved a staggering number In terms of quantity or volume of generic medicines that it produces not just for India, but for many developed, developing and poorer countries, across the world. For this reason, India is popularly … 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
Would ‘Regenerative Medicine’ Shape The Future Of Global Healthcare?
Just the last week, on December 19, 2014, international media broke the news of regulatory approval of the first stem cell treatment by the European Medicines Agency (EMA). The Agency reportedly has recommended an Orphan Drug – Holoclar of the … Continue reading
Scandalizing Biosimilar Drugs With Safety Concerns
With the patent expiry of exorbitantly priced biologic medicines, introduction of biosimilar drugs are expected to improve their access to millions of patients across the world, saving billions of dollars in healthcare costs in the subsequent years. According to an … Continue reading