Improving Patient Access To Biosimilar Drugs: Two Key Barriers

Novel biologic medicines have unlocked a new frontier offering more effective treatment for a host of chronic and life-threatening diseases, such as varieties of cancer, rheumatoid arthritis and diabetes, to name just a few. However, these drugs being hugely expensive, … Continue reading

Stem Cell Therapy in India: A Potential Game Changer in Disease Treatment

Stem Cells (SC) offer an incredible potential to instill a new lease of life virtually to any organ of the human body, bringing them back to the pre-disease state through its own biological repair mechanism. Intensive research initiatives are on … Continue reading

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

Pharma Outlook 2015: A Glimpse Of Some Drivers and Barriers

Looking ahead, the brand new year 2015 appears quite interesting to me both from the global and also from the local pharmaceutical industry perspective. In this article I shall try to give a glimpse of some of the important drivers … 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

Patients’ Safety, regulatory approval of Biosimilar Drugs in India and WHO Biosimilar guidelines

Biopharmaceutical drugs are broadly defined as: ”Those medicines produced using a living system or genetically modified organism. These drugs are different from traditional chemical medicines in many ways. Size of the molecule is one of the most obvious distinctions: the … Continue reading