The Curious Conundrum of New Drugs Approval Process

Fathoming the details of just a short span of time, not going beyond the last 10 years, I find from the published data that many new drugs, such as, Alatrofloxacin, Aprotinin, Drotrecogin alfa, Lumiracoxib, Propoxyphene, Rofecoxib, Rosiglitazone, Sibutramine, Tegaserod, Tetrazepam, were … 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

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

Patented Drugs’ Pricing: Apprehensive Voices Could Turn into a Self-Defeating Prophecy

On February 21, 2013, the Department of Pharmaceuticals in a communication to the stakeholders announced that the committee to examine the issues of ‘Price Negotiations for Patented Drugs’ has since submitted its report to the Department. Simultaneously the stakeholders were … Continue reading