Why 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 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?

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#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

Clinical 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 unprecedented crisis of confidence, that's not terribly surprising . However, much of this effort's success will depend on the regulatory reform that … Continue reading Clinical trials in India : Can industry push regulator to act?

Guest 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 organisation Karmic Life Sciences. Views expressed are personal. In recent months, clinical trials conducted in India have been in the news for all … Continue reading Guest column : 5 deficits threatening clinical research in India

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, compensation to subjects and so on.  Call me an optimist but this could be one of the best things to have happened to the sector in … Continue reading India and clinical trials : in the dock?