On January 16, 2017, quoting a Government source, a media report revealed, “India’s drug regulator is looking to inspect US pharmaceutical facilities, making critical medicines so that only high-quality products are imported from them.” This intent follows a similar decision … Continue reading
Tag Archives: European
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
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
Balancing IPR with Public Health Interest: Brickbats, Power Play and Bouquets
It is now a widely accepted dictum that Intellectual Property Rights (IPR), especially pharma patents, help fostering innovation and is critical in meeting unmet needs of the patients. However, the moot question still remains, what type pharmaceutical invention, should deserve … 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
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 drug prices are Astronomical, Unsustainable and Immoral” – Anatomy of Unique Protests
Yes. The quoted sentiment captured in the headline was reportedly voiced recently by many cancer specialists, including researchers and that too in the heartland of pharmaceutical innovation of the world– the United States of America. These specialist doctors argued: “High … Continue reading
EU-FTA, TRIPS-Plus provisions, Data Exclusivity, Public Interest and India
Business Standard in its January 27, 2011 edition reported, “Data Exclusivity still key hurdle to India-EU FTA” Before deliberating on this important issue of “Free Trade Agreement (FTA)”, let me touch upon very briefly, for the benefit of all concerned, … Continue reading