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

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

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

NDDS as New Drug: Good for Patients, Great for Pharma

The Ministry of Health of India has reportedly decided to amend Rule 122 (E) of the Drugs and Cosmetics Rules, 1945 to categorize the New Drug Delivery Systems (NDDS), including ‘Controlled Release (CR)’ or ‘Modified Release (MR)’ formulations, whether a … 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

Pioglitazone Conundrum: Should The Drug Regulator Step Over The Line?

Recent order of the Indian drug regulator to withdraw all formulations of the well known, yet controversial, anti-diabetic drug – Pioglitazone from the domestic market has created a flutter in the country, ruffling many feathers at the same time. Withdrawal … Continue reading

Prescribing medicines by generic names…a good intent… but is it a practical proposition in India?

Parliamentary Standing Committee for Health and Family Welfare in their recommendation to the ‘Rajya Sabha’ of the Indian Parliament on August 4, 2010, recommended prescription of medicines by their generic names. This recommendation appears to be based on the premises … 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