The DP/ DE Deadlock: When can we move towards a resolution?

The DP/ DE Deadlock: When can we move towards a resolution?
The Indian pharmaceutical industry has always been divided on the contentious issue of Data Protection/Data Exclusivity (DP/DE). And the issue promises to get more complicated. Express Pharma gets some of the stakeholders and experts to make their case …

Monopolising clinical trial data: implications for generic production
In India, much of the debate on TRIPS, intellectual property (IP) and generic production has focused on patents. Outside the limelight in bilateral meetings and negotiations the notion of Data Exclusivity (DE) for pharmaceuticals is quietly been introduced and promoted with Indian policy makers

Failure to provide DP would lead to ‘unfair commercial use’
To meet the unmet needs of the patients and improve access to healthcare in India mere discovery of a new pharmaceutical entity is not enough

International standard RDP will provide the correct incentives to innovate
Incentives for investment in research and development are necessary for discovery of new medicines, especially as regulatory regimes around the world require more safety and efficacy data

Safeguarding patient well-being
Despite the progress made in the past two decades, healthcare facilities in India are still a long way off from bringing morbidity and mortality rates down to global levels

Findings from the 2010 IBM Global CEO Study
The study highlights how CEOs, and Indian CEOs in particular, are finding ways to handle a new primary challenge: complexity