Dr Ajaz S Hussain, Former Deputy Director Office of Pharmaceutical Science, US FDA, currently Founder of Insight,Advice & Solutions, US and President, National Institute for Pharmaceutical Technology and Education (NIPTE), US, gives an Indian-American and an ex-USFDA leader’s perspective on the current challenges related to cGMP non-compliance and quality of generic drug applications. He urges academia all over the world to work toward a reform of pharmaceutical science and technology education and develop a meaningful certification process for the 21st century
Generic drugs are themost effective meansto enhance the affordability of medicines in the US. The Hatch-Waxman Amendments to the FD&C Act achieved a sustainable way to ensure generic drugs would be available immediately following statutory patent protection, and marketing exclusivity for new (or brand) drugs had expired. The affordability (public health) objective was balanced with innovation (public health) objective by providing new (or brand name) drug manufacturers a significant statuary patent protection and a period of marketing exclusivity so that the investment in the development new drugs is recovered.
In 2016, the faculty of National Institute of Pharmaceutical Technology (NIPTE) deliberated within and with the US FDA on how to confidently ensure availability of First generic. Also, the collaboration between Sun Academy and NIPTE on Quality by Design Education and Certification was progressed (1).
In this report, which builds on Part I published in Express Pharma November 1-15, 2013 (2), I wish to share with the target audience in India what NIPTE (a not-for-profit collaboration among 17 top US University) aims to contribute. Specifically, about New Prior Knowledge (note the oxymoron is by design) and Education with Certification. However, before doing so, I wish to position this discussion in a broader context particularly the on-going discussion in India triggered by Prime Minster Modi ji’s proposal to progress a legal framework which essentially seeks to create an automatic substitution mechanism for generic drugs in India (as in the US).
Generic substitution in India and the questionWho makes the drug?
Bu hikaye Express Pharma dergisinin May 16, 2017 sayısından alınmıştır.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber ? Giriş Yap
Bu hikaye Express Pharma dergisinin May 16, 2017 sayısından alınmıştır.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber? Giriş Yap
MAKING SUSTAINABILITY SUSTAINABLE
Driven by stringent regulations, rising investor expectations, consumer demand, and operational considerations, MSME pharma companies need to carefully balance their sustainability goals with financial viability
New energy recovery system for tablet coaters
Upto 50 per cent less steam energy consumption
The future of pharma logistics: Trends, challenges, and opportunities
Nikhil Agarwal, President, CJ Darcl Logistics explains that the future of pharma logistics is a thrilling frontier shaped by technological advancements, regulatory challenges, and the imperative of sustainability. As the industry transforms, logistics providers must embrace innovative solutions and adapt to shifting demands
Achieving Aatmanirbharta In APIs Are We On The Right Track?
As India gears up to celebrate its 75th Independence Day, self reliance in APIs remains a key goal for the pharma sector. AatmaNirbharta will be crucial for the sector as it continues to protect the country from the existing and emerging health threats
Yokogawa launches OpreX Data Model Broker
A plant data transformation platform, OpreX automatically verifies discrepancies and inconsistencies in data to improve efficiency in plant construction and operation
Understanding the nuances of generics injectables
At a webinar, explaining the West Pharma's AccelTRA Components Program, industry experts explained why the use of glass vials and stoppers as primary container closure systems (CCS) has become crucial
Trending in nutraceuticals: Science meets sustainability
Zeljko Pockaj, Vice President, Global Pharmaceutical Industry, mentions the key trends that are believed to drive innovations and formulations for nutraceuticals’ development around the globe
The growth of e-pharmacies in India
Rahul Nath Choudhury, Research fellow, ICWA, explains what motivates people in the pharma industry to invest into e-pharmacies, along with various other growth factors associated with these
Xylitol and Maltitol: Low-calorie sugar alternatives
Polyols like Xylitol and Maltitol offer important health benefits. Unlike general sugar-free sweeteners, these do not have any bitter-after taste
Single-use TC gaskets and their importance
Depending on the application, gaskets are manufactured by different types of Material of Construction (MOC) such as Silicone, EPDM, Viton (FKM), Nitrile, Neoprene, PTFE, etc.