On April 13, 2016, an article in the Wall Street Journal (WSJ) titled, “Clinical Trials Need More Subjects” underscored an important point that the rate at which the clinical researchers are able to recruit and retain patients for ‘Clinical Trials … Continue reading
Tag Archives: CT
Is Credibility Erosion of Pharma Accelerating?
‘Big Pharma’ now seems to be desperately trying to gain the long lost high moral ground by pushing hard its gigantic image makeover juggernaut, maintaining a strong pitch on the relevance of stringent Intellectual Property Rights (IPR) in the lives … Continue reading
“Make Global Pharma Responsible in Homeland for Objectionable Conduct in Clinical Trials Elsewhere”
In the context of his recent meeting with Commissioner Margaret A. Hamburg of US-FDA, the Drug Controller General of India (DCGI) reportedly expressed his concern to ‘The Economic Times’ on the ‘objectionable conduct’ of global pharma in new drug trials … Continue reading
New Clinical Trial Regime Deserves Support, Sans Threats
Recent Supreme Court intervention compelling the Union Government to enforce stringent regulations both for approval and conduct of Clinical Trials (CT) in India, has unfortunately met with some strong resistance with stronger words. Some of these voices are from credible … 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
Sets 2013, Dawns 2014: Top 7 Pharma Developments
Wish You Good Health, Happiness, Success and Prosperity in 2014 In this article I shall focus on ‘Top 7 Pharma Developments’, both while ‘Looking Back to 2013′ and also during my ‘Crystal Gazing 2014′. Looking Back to 2013: While looking … Continue reading
Supreme Court Suspends New Drug Trials in India…Time to Shape Up?
On September 30, 2013, with a damning stricture to the Drug Regulator, the Supreme Court, in response to a Public Interest Litigation (PIL) filed by the NGO Swasthya Adhikar Manch, stayed approvals for 162 applications for local Clinical Trials (CTs) of new … Continue reading
Transparency in Drug Trial Data: Thwarted by Lobbyists or Embroiled in Controversy?
Based on a leaked letter from overseas pharma industry bodies, a leading international daily in late July 2013 reported: “Big pharma mobilizing patients in battle over drugs trials data.” Some experts consider it as a poignant, if not a bizarre … Continue reading