On January 16, 2017, quoting a Government source, a media report revealed, “India’s drug regulator is looking to inspect US pharmaceutical facilities, making critical medicines so that only high-quality products are imported from them.” This intent follows a similar decision … Continue reading
Tag Archives: ban
Is The Global Generic Drug Market Slowing Down?
Driven by a strong environmental headwind, both within and outside the country, several pharma companies in India have recently started raising a red flag on their future earning guidance for the stock market, though citing quite different reasons altogether. Quoting … 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
‘Indian Drug Control World’s Weakest: Pharma Trade Bodies Working At Cross Purposes’
“In the entire world, I think our drug control system probably is the weakest today. It needs to be strengthened,” said the Secretary of the Department of Pharmaceuticals (DoP) – V K Subburaj at an event in New-Delhi on April … 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
The Recent Ban On Irrational FDCs: History Repeats Itself
The recent regulatory ban on a large number of irrational Fixed Dose Combination (FDC) drugs is not a new incident in India. A similar mega ban was announced even before, about nine years ago. Intriguingly, the saga continues, for various … 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
Booming Sales Of Unapproved Drugs: Do We Need “Safe In India” Campaign For Medicines?
“To sin by silence when they should protest makes cowards of men” - Abraham Lincoln Not just the Federal Drug Administration of the United States (USFDA), global concerns are being expressed … Continue reading