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

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

For Drug Safety Concern: “Whistleblower’s Intention Should Be Nationalistic”

In the recent weeks, three significant developments related to the Pharmaceutical Industry in India, have triggered rejuvenated concerns in the following critical areas:  A. Overall drug safety standards in the country B.  Self serving interest, rather than patients’ interest, dominate … 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

Does ‘Free-Market Economy’ Work For Branded Generic Drugs In India?

On April 20, 2015, a panel of 31 lawmakers of the Standing Committee on Chemicals and Fertilizers tabled its report in the Indian Parliament. The committee emphasized that patients in India should have access to all medicines, including life saving drugs, … Continue reading

Big Pharma Receives Another Body Blow: Would Indian Slumber End Now?

On May 13, 2014, The New York Times reported, while major pharmaceutical companies have been facing increased scrutiny of their marketing practices from governments around the world, last Wednesday the Chinese authorities sent a strong warning to the pharmaceutical industry … 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

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