Why Pharma Doesn't Always Keep Phase IV Promises In India
Are drug firms being lax when it comes to Phase IV studies in markets like India or are certain arbitrarily determined regulatory requirements largely to blame? Scrip delves into the issue.
You may also be interested in...
Roche is working towards implementing PMS studies for Avastin (bevacizumab) and ensuring that a suspension of marketing authorization for the product in first line ovarian cancer is lifted in India.
AstraZeneca, which recently committed to scaling up investments in India, appears on course to bringing two key new anticancers to the country, including the PD-1/L1 inhibitor Imfinzi. Pricing aspects for the products in what is a largely out-of-pocket market are, however, expected to be decisive.
India’s draft new drugs and clinical trials rules come with a prickly "no claims" clause pertaining to payment of “interim compensation” by sponsors in specific circumstances, based on an initial causality assessment by ethics committees (ECs). The new rules, at least in their current form, also give ECs near "quasi- regulatory powers" say some experts.