The central government, through the office of the Indian drugs regulator, has done away with the cap on the number of clinical trials per investigator. This is after it was pointed out by clinical research stakeholders such as sponsors and investigators, that this could lead to under-utilisation of clinical trials infrastructure, and investigator expertise. The … Continue reading Why did India remove cap on number of #clinicaltrials per investigator?
Tag: cdsco
#Clinicaltrials : Are India’s Ethics Committees weak links in the chain?
Clinical trials, that hot-button subject hogging headlines up until a year ago, appears to have quietly slipped into the realm of business-as-usual. However, there are still some knotty issues to be resolved. Chief among them is the oversight of Ethics Committees (ECs) as was evident at a recent event I attended. ECs - which are … Continue reading #Clinicaltrials : Are India’s Ethics Committees weak links in the chain?
India #Pharma 2014 : A quick look back. Part Two #clinicaltrials #pharmacovigilance
The holiday season approaches, so here’s a quick look at the year that was for Indian Pharma, before we disappear into a haze of year-end festivities. It’s a mixed bag (what year isn’t?) including stuff that could influence the way things work in the years ahead. For convenience, I’ve divided up what I think are … Continue reading India #Pharma 2014 : A quick look back. Part Two #clinicaltrials #pharmacovigilance
India and clinical trials/drug safety : Progress. And questions
India's drugs regulatory office, the Central Drugs Standard Control Organisation (CDSCO), recently issued a raft of notices on the subject of clinical trials and drug safety. While the sheer number of them - 14 'orders' dated July 3 - does raise an eyebrow or two, the communiques are noteworthy as they address issues that have … Continue reading India and clinical trials/drug safety : Progress. And questions
CDSCO’s PR: Indian drug regulator has new mission!
While looking for something else entirely, I stumbled upon information on the drug regulator CDSCO's home page that appears relatively recent. Sort of a FAQ on the authority. In spite of cringeing at the tacky slide show that hogs most of the homepage, I was struck by some of its contents. There's a vision statement. … Continue reading CDSCO’s PR: Indian drug regulator has new mission!
India’s move to vanilla generics : Don’t hold your breath
By now, the news that India wants to move away from branded generics and encourage vanilla generics to bring down drug prices has gone around the world. But all those who think a structural reform of the Indian drug industry is around the corner : stop. And breathe. First, for the record, the news. The … Continue reading India’s move to vanilla generics : Don’t hold your breath
Apothecurry 