Strategies For Making High Pharmaceutical Quality Affordable: Part II

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?