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
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. And a mission. And values. Continue reading
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. Continue reading