Clinical Trials: Critical Need To Improve Patient Participation With Informed Consent

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

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

Pharma Innovation Absolutely Critical: But NOT Shorn from Ethics, Propriety, Compliance and Values

Significant value added innovation is the bedrock of progress of the pharmaceutical industry and is essential for the patients. This is a hard fact. However, this current buzzword – ‘innovation’ can in no way be shorn from soft business necessities … Continue reading

New ‘Patient Compensation’ Norms on Clinical Trials in India: Overdue Action, Sharp Reaction and Ethical Issues

Responding to the damning stricture made by the Supreme Court on January 3, 2013, the Ministry of Health, as expected, by a gazette notification of January 30, 2013 has made the norms of compensation to patients participating in Clinical Trials … 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