Guest column : Indian patent rulings and pharma strategies

The Indian government made several critical patent decisions over the past year.  Their impact on the Indian intellectual property (IP) landscape is still evolving, with important implications for IP rights, the global pharmaceutical industry, Indian consumers, and emerging economies. The stakes are high and reflecting on the ways in which these decisions will shape the …

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Enough said, it’s time to act : my article in PICR

Late last year, I submitted an article to the journal Perspectives in Clinical Research (PICR), brought out by the Indian Society for Clinical Research (ISCR). This issue of PICR is titled "Ethics in Clinical Research" with contributions from bioethicians, patient advocates, trial sponsors and investigators, among others. The publishers informed me yesterday that the issue …

India & clinical trials: PhRMA weighs in

In a guest column, Jay Taylor, vice-president (international affairs) at US-headquartered Pharmaceutical Research and Manufacturers of America (PhRMA), a vocal representative of Big Pharma interests, argues that "much of the characterization of the clinical trial environment has been sensationalized.. (is) overstated or simply wrong." Among other things, he states that the death rate for patients …

Clinical trials in India : Can industry push regulator to act?

A recent meeting that Apothecurry had with clinical research industry executives in Mumbai suggests that the sector intends making a strong push to salvage its tattered image. Faced as it is by an unprecedented crisis of confidence, that's not terribly surprising . However, much of this effort's success will depend on the regulatory reform that …

India and drug safety : Latest PVig attempt showing promise

India seems to be making slow but sure progress towards reversing its abysmal track record in pharmacovigilance - medical jargon for monitoring the safety of marketed medicines. The country has reported 33,702 adverse drug reactions (ADRs),  side-effects arising from a host of marketed drugs, as of December 21, 2012,  according to data shared by the …