Amid high decibel deliberations on Covid-19 pandemic, something similar to groundbreaking happened – involving Biosimilar drugs, in just a couple of months ago. On July 28, 2021, in the Eldorado of the pharma industry, the US-FDA approved the first ‘interchangeable’ biosimilar drug, … Continue reading
Tag Archives: Regulatory
Unfettered ‘Access To Drug Innovation’ – An Oxymoron?
The mass paranoia, as it were, over Covid pandemic has now started fading with drug regulators’ ‘emergency approval’ of several Covid -19 vaccines, and its free of cost access to all, generally in most countries. As the endgame of the pandemic, … Continue reading
India Not To Vaccinate All For Covid Control: Upsides And Unknowns
With 9.46 million cases and 137,621 deaths, India has currently the world’s second-highest number of coronavirus infections, behind only the United States, reported Reuters on December 01, 2020. Fathoming seriousness of rapidly unfolding Covid induced all round disruptions across the nation, on … Continue reading
Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India
“Bottle Of Lies Exposes The Dark Side Of The Generic-Drug Boom” – re-emphasized the book, released in May 2019. This confirms, the raging debate on the questionable quality of many generic drugs manufactured in India and involving several top domestic pharma companies, … Continue reading
Is India A Success Story With Biosimilar Drugs?
How Indian generic companies are expanding, if not shifting their business focus on biosimilar and complex generic drugs, may be a current trend of general discourse – but the initiative is not a current one. This journey commenced decades ago … Continue reading
An Interesting demand: No Price Control For OTC Drugs
Since over a decade, some pharma trade organizations operating in India, have been advocating for a separate regulatory policy for ‘Over The Counter (OTC)’ drugs, which can be legally sold without any medical prescriptions. Such a new policy initiative, if taken by … Continue reading
Why MNC Pharma Still Moans Over Indian IP Ecosystem?
Improving patient access to expensive drugs, paving the way for entry of their cheaper generic equivalents, post patent expiry, and avoiding evergreening, is assuming priority a priority focus area in many countries. The United States is no exception, in this … Continue reading
Prescription Digital Therapy Now A Reality
The pursuit of offering ‘prescription digital therapeutics’ or ‘digiceuticals’ by Big Pharma, to ensure better clinical outcomes for patients, has apparently come to fruition now. On April 18, 2018, by a media release, Novartis announced that the Sandoz Division of the Company … Continue reading