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 decision is now left to the Ethics Committe (EC) of the institution where the trial is to be conducted as was recommended by the Expert Committee set up by the government under the late Ranjit Roy Chaudhury. This is clearly a great relief to those involved in the conduct of clinical trials.
But at the risk of sounding like a wet blanket, I have to say – this sounds suspiciously like one of those on-again, off-again decisions that pretty much leave you where you started off with, wondering what really was achieved. Continue reading
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 a mix of experts and lay persons – are the gatekeepers of ethics within their institutions. Just as a strong EC can blow the whistle on unethical behaviour, a weak or careless one might inadvertently abet it. Continue reading
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 key developments into posts rather than stick to any specific chronology of events. The first post was on the regulation of Indian manufacturing. In this second post, I look at developments in the regulation of clinical trials. Continue reading
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 turned clinical trials and drug safety in India into a lightning rod for controversy. The orders are based on a report of an Expert Committee headed by Dr Ranjit Roy Chaudhury and set up by the Health Ministry “to formulate policy and guidelines to approve new drugs, clinical trials and the banning of drugs.” Here’s my view on some of these orders. Continue reading
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 the industry can force in the coming months and years. Continue reading
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 the wrong reasons. Here are five reasons why they may continue to be. Continue reading
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 recent years. Continue reading