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

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

Pharma FDI Debate: Highly Opinionated, Sans Assessment of Tangible Outcomes?

In 2001, the Government of India (GoI) allowed 100 percent Foreign Direct Investments (FDI) in the pharmaceutical sector through automatic route to attract more investments for new asset creation, boost R&D, new job creation and ultimately to help aligning Indian … 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