Generic Drug Quality: Cacophony Masks An Important Note, Creates A Pariah

In the ongoing debate between branded-generics and generic drugs without brand names, the concern about drug quality is occupying the center stage, with the former generally being painted in white, and the later in black – with no shades of … Continue reading

Even Smaller Countries Now Question Indian Drug Quality Standard

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

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

Escalating Antibiotic Resistance, And Thwarting Ban Of Irrational FDCs

September 2016 ‘Fact Sheet’ of the World Health Organization (W.H.O) raised a red flag on fast increasing incidence of Antimicrobial Resistance (AMR). It poses a serious threat to global public health, more than ever before. Consequently, effective prevention and treatment … Continue reading

Counterfeit Drugs In India: A Malady Much Deeper

Many debates and discussions continue being lined up in India almost regularly, generally by the pharma trade associations, besides a few others, on the issue of counterfeit drugs. A good number of these events are sponsored by the global and … 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

Nutraceuticals: Make The Fragile Regulatory Space Robust, Soon

In the space between drugs and nutrition, there is an intriguing ‘gray area’ with significant business relevance, especially in India. In a related publication, A.T. Kearney – a leading global management consulting firm has elaborated it as below: “At one end … 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