Amid ongoing Covid pandemic, most discussions on pharma specific ‘digitalization’ initiatives continue to predominantly hover around its traditional business growth drivers. In fact, even before the Covid time, it was no different, in a smaller scale and with a lesser … Continue reading
Tag Archives: Guidelines
Is India A Success Story With Biosimilar Drugs?
How Indian generic companies are expanding, if not shifting their business focus on biosimilar and complex generic drugs, may be a current trend of general discourse – but the initiative is not a current one. This journey commenced decades ago … Continue reading
A ‘Toxin’ Delaying Success of Biosimilar Drugs
The above comment, although sounds a bit harsh, was made recently by none other than Scott Gottlieb - the Food and Drug Administration Commissioner of the United States. He expressed his anguish while explaining the reasons for a delayed launch of several important … Continue reading
Nutraceuticals: Still An Oasis Amidst Well-Regulated Pharmaceuticals
On November 24, 2016, the food-safety watchdog of India announced that health supplements or Nutraceuticals cannot be sold as ‘medicines’ anymore. This new regulatory standard has been set for the manufacturers of Nutraceuticals and food supplements, and is aimed at … 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
Biosimilar Drugs: First Indian Foot Print In An Uncharted Frontier
A homegrown Indian biologic manufacturer is now about to leave behind its first foot-print, with a ‘made in India’ biosimilar drug, in one of the largest pharma market of the world. This was indeed an uncharted frontier, and a dream … 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
Biosimilar Drugs: Why Prescriptions Aren’t Still Enough?
On September 3, 2015, in a Press Release, Novartis announced, “Zarxio(TM) (filgrastim-sndz) is now available in the United States. Zarxio is the first biosimilar approved by the US Food and Drug Administration (FDA) and the first to launch in the … Continue reading