India and clinical trials : in the dock?
India’s Supreme Court has expressed concern at the conduct of clinical trials asking the government to provide information on the number of trials being conducted, adverse event reports, deaths,...
View ArticleGuest column : 5 deficits threatening clinical research in India
Introducing a guest column by Dr S M Sapatnekar who has remained a member of the National Advisory Committee for Bioethics Education in India and is Medical Director of Mumbai-based clinical research...
View ArticleClinical trials in India : Can industry push regulator to act?
A recent meeting that Apothecurry had with clinical research industry executives in Mumbai suggests that the sector intends making a strong push to salvage its tattered image. Faced as it is by an...
View ArticleIndia 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...
View ArticleIndia #Pharma 2014 : A quick look back. Part Two #clinicaltrials...
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...
View Article#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...
View ArticleWhy did India remove cap on number of #clinicaltrials per investigator?
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...
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