Drug trials : India’s crisis of confidence

Reuters reports that in the last decade fewer children are dying of leukemia most likely due to advances in new drug combinations. However, infants are still getting a more aggressive form of the disease as a result of which survival rates are lower than those for young children and adolescents.

In spite of the strides made in medicine and supportive care, most would agree that the quest for new treatments for intractable medical problems such as childhood leukemia has to continue, even accelerate.

But in recent years, it appears that a crucial part of this process- the  testing of these new treatments on human subjects to prove their safety and efficacy – is experiencing a serious crisis of confidence in India.

What’s happened?

Here, the regulatory system thanks to poor governance and little transparency  has failed to deter large parts of civil society and some very voluble politicians from turning against drug trials on Indians. The Indian government has dithered on everything from the inspection of trial sites to standard-setting to fixing blame (or clearing of blame, as the case may be) in the case of allegedly botched trials.

Media reports from within and outside the country have focused the spotlight on violations – some real, some imagined –  of the rules governing the conduct of trials by sponsors (often drug companies) and their agents in the form of contract research organisations (CROs).

Feeling cornered, drug industry and CRO executives have lashed out at the media and the government. But even they prefer to defend their own practices rather than those of the industry as a whole suggesting they don’t really know who’s playing fair and who isn’t.

Government’s response has been to go slow on all trial approvals.

What’s to be done? Most of the problems with drug trials in India have been discussed at length. It’s time to implement some of the solutions. Like mandating the video-taping of the consent process.  Inspecting trial sites.  Publicizing the results of investigations into unethical conduct. Publishing warning letters to sponsors, CROs and sites.

It is not that all trials all over the world are conducted spotlessly. The US, with arguably among the most stringent regulatory standards for medicine, has made mistakes. But there is also enough evidence of the regulatory system at work in the form of inspections, letters of violation written to companies, reports, statistics on audits, etc that are accessible to the public at large in whole or part.

World over, the clinical trials discipline is also evolving continuously to plug loopholes, put in more safeguards, and ensure equity.

India should not let this crisis of confidence go on unaddressed. It has a lot to offer clinical research and much to gain from it.

New drugs will not stop coming to market if India opts out of clinical trials. But discouraging drug trials sends out the message that Indians want the fruits of research but would rather be excused from being part of the effort.

Worse,  it deprives Indians of access to experimental drugs that might end up saving a dying parent or child.


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