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?
Denne historien er fra May 16, 2017-utgaven av Express Pharma.
Start din 7-dagers gratis prøveperiode på Magzter GOLD for å få tilgang til tusenvis av utvalgte premiumhistorier og 9000+ magasiner og aviser.
Allerede abonnent ? Logg på
Denne historien er fra May 16, 2017-utgaven av Express Pharma.
Start din 7-dagers gratis prøveperiode på Magzter GOLD for å få tilgang til tusenvis av utvalgte premiumhistorier og 9000+ magasiner og aviser.
Allerede abonnent? Logg på
Powerful Process Control with IND500x Weighing Indicators
Ensuring consistent quality in hazardous environments, particularly in Ex-Areas (Zone 1/21, Division 1), is a critical aspect of industrial operations. The IND500x weighing indicators from METTLER TOLEDO provide a robust solution for these challenging settings, offering optimized safety and productivity.
Ensuring clean room integrity with prime clean reset high-speed doors
Prime Clean Reset high-speed doors ensure airtight seals, minimising air permeability and contamination in clean rooms. Designed for sensitive environments, they enhance operational efficiency and meet rigorous regulatory standards, making them ideal for pharmaceutical and biotech industries
Complete environmental monitoring solution - testo Saveris Pharma
There are several critical applications in the industry like research and development that demand for continuous & reliable monitoring of important environmental parameters.
Adaptive Manufacturing:-The new flexibility in medical device assembly
Unlike traditional, rigid production lines, B&R's adaptive machines seamlessly adjust to the requirements of each device, dynamically adapting to each unique process
Reshaping pharma safety with active packaging innovations
CILICANT is revolutionising active packaging with solutions tailored for the most sensitive formulations. Meet the innovators driving stability, safety, and impurity control in pharma packaging at CPhI India
UNLOCKING GROWTH FRONTIERS
Vadodara Pharma Summit 2024 brought together industry leaders and experts to highlight the city's pivotal role in India's pharma landscape and explore collaborative strategies to strengthen India's pharma innovation ecosystem
Optimising cloud provisioning for pharmaceutical compliance and operational excellence
Suresh Perikala, Senior Engineering Lead - DevOps and Cloud Engineering Practice, Altimetrik
Accelerating pharma's sustainability efforts
Avinaw Prasad, Director, Climate Change & Sustainability, Deloitte India explains why integrating sustainability into the core pharma business strategy is essential for long-term success, analyses key focus areas and policy pushes which can incentivise companies to further evolve on the sustainability path
Drug Repurposing: Unlocking access to rare solutions
Drug repurposing, a quick, cost-effective path to deliver existing treatments to patients, can serve to expedite and expand healthcare access for patients with rare diseases
Optimising spend, maximising growth
Express Pharma, in partnership with IPA and CHEMEXCIL, powered by SAP, recently organised a thought leadership conclave on 'Reimagining spend management and supply chain' where cross functional experts explored strategies to drive value through supply chain transformation