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
Tag Archives: Dose
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
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
FDC Saga: Defiant Manufacturers, Sloppy Regulators and Humongous Inaction
“TO SIN BY SILENCE WHEN THEY SHOULD PROTEST MAKES COWARDS OF MEN” – Abraham Lincoln The ghost of untested, irrational and even of bizarre kind of Fixed Dose Combination (FDC) drugs, which continue to be launched, promoted, prescribed … Continue reading
Fixed Dose Combination’ drugs market in India is growing faster – are there enough regulatory checks and balances to prevent market entry of ‘irrational combinations’ to ensure patients’ safety?
The WHO Model of FDCs:The 2005 ʹProcedure to update and disseminate the WHO Model List of Essential Medicines, Criteria for Selection‘ includes the following statement regarding fixed dose combination products (FDCs):ʺMost essential medicines should be formulated as single compounds. Fixed‐dose … Continue reading