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
Tag Archives: regulator
‘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
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
Beyond ‘The Magic Moment’ of New Drug Marketing Approval
“Uncontrolled clinical trials are causing havoc to human life. There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far.” This is exactly what the Supreme Court of India observed … Continue reading
‘Havoc’ and its ‘Aftermath’: Clinical Trials in India
Just as the New Year dawned, on January 3, 2013, in an embarrassing indictment to the Government, the bench of honorable justices R.M Lodha and A.R Dave of the Supreme Court reportedly observed that uncontrolled Clinical Trials (CT) are creating … Continue reading
“Indian Drug Regulator Accords Primacy to Pharma Industry Instead of Safegurding Public Health and Safety” – Parliamentary Committee
The Department Related Parliamentary Committee on Health and Family Welfare presented its 59th Report of 118 pages in total on the functioning of the Indian Drug Regulator – the Central Drug Standards Control Organization (CDSCO) in both the houses of … Continue reading
Quick implementation of the UNDILUTED ‘Central Drug Authority (CDA)’ Bill is essential for emerging India
Many industry experts after having carefully evaluated the provisions of the original draft of the proposal of forming a CDA in the country commended and supported this praiseworthy initiative of the Government. This Bill also known as, “The Drugs & … Continue reading