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

Dwindling Drug Innovation: Declining Image: Unchanged Business And Advocacy Models

A report of ‘The United States International Trade Commission (USITC)’ released on December 22, 2014 suggested, if tariffs and investment restrictions were fully eliminated, and standards of IP protection were made comparable to the U.S and Western European levels, American … Continue reading

At The Indian IPR Front: ‘Ground Control, There’s No Major Storm’

The incessant pressure of the developing countries on India, from 2005 to date, to include various restrictive conditions in the Indian Patents Act 2005, still continue. This demand spans across the inclusion of even those provisions, which many experts term … Continue reading

Biosimilar Drugs: First Indian Foot Print In An Uncharted Frontier

A homegrown Indian biologic manufacturer is now about to leave behind its first foot-print, with a ‘made in India’ biosimilar drug, in one of the largest pharma market of the world. This was indeed an uncharted frontier, and a dream … Continue reading

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 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

Nutraceuticals: A Major Regulatory Step That Was Long Overdue

Currently in India the nutraceutical products segment, with surrogate or off-label therapeutic claims, is growing at a reasonable pace. Many such products are now being directly promoted to the medical profession, just like any other modern medicines, with therapeutic claims … Continue reading

Data Manipulation: Leapfrogging Dangerously Into Clinical Trial Domain

Over the last several years, repeated allegations of gross data manipulative practices, detected by global drug regulatory agencies, such as USFDA and MHRA, have shaken the Indian pharma exporting companies hard. This has been hurting the overall business performance of … Continue reading