The many downsides and one upside of India's clinical trials mess


Hardly a week goes by when the term ˜clinical trial” is not in news, and unfortunately, in recent times, it’s been more for the wrong reasons. On January 9, Financial Times reported Novartis will face a criminal investigation for wrongful marketing practices of its popular blood pressure medicine Diovan. Then there was this detailed study on the whole exercise around suppressing Tamiflu data. Tamiflu is perhaps the test case of data sharing, so much so that the British Medical Journal has been crusading for access to its clinical trial data.


Pharma companies crib, in private, that they have become media’s punching bag. I wouldn’t agree with it but what has happened in India borders on that because it’s the regulatory regime and its incompetence and apathy that have brought the clinical research sector to a complete halt. India is home to nearly 2 percent of global clinical trials, even though it shares as much as 20 percent of the global disease burden. Unarguably, many more trials should be happening here. But the fact is today even the academic clinical research in the country has been severely impacted as all international agencies, like the National Institutes of Health (US), Medical Research Council (UK), Canadian Institutes of Health Research, and Wellcome Trust, have put on hold their clinical research in India. This is alarming because these agencies fund large public health projects and India’s absence from those studies will have adverse impact on new findings or drugs being used in the country.


Clinical research dropped by over 50 percent in 2013 and various institutes (some fly-by night operators too) that offer one or two year diploma or degree courses in clinical research are struggling. (Guardians need to be watchful and must seek placement guarantees before getting their wards enrolled in these institutions.) Still, the annual conference of the Indian Society for Clinical Research in Bangalore last week started on an optimistic note. Veteran academic clinical researcher at St John’s Hospital in Bangalore, Dr Prem Pais believes that like the Indian economy, clinical research sector will get back on track within a year.


After the year-long near-ban on clinical trials in 2013, India now has a blueprint in the form of Ranjit Roy Chaudhury committee report which, if followed in principle, would sort out the tangle that clinical research organizations, drug companies, academic research institutions and the health ministry find themselves in.


The 15-page report has 27 actionable items, some of them requiring amendments in Schedule Y of the Drugs and Cosmetics Act of India. Given how this nation presses the pause button in the name of politics, one wonders if any file will move until the elections are over in May.

Missing medicine data

Missing data in our medicines

Since discussions will be on throughout the year, I’d like to plug an idea, more so because the flavour of the season is openness in data. Currently, Indian regulations require all sponsored clinical trials in the country to be registered in the Indian Council of Medical Research registry. How about these trials also committing to register their study results regardless of the outcome? The regulators may choose to disclose the results only to bonafide seekers.


Globally, as in India, there has been a clear trust deficit between the consumers/advocacy groups and the drug companies. In response to that, five drug companies Boehringer Ingelheim, GSK, Roche, Sanofi and ViiV Healthcare, have committed to sharing trial data on this site.


Advocacy groups say most of the medicines in use today have been tested in clinical trials over the last 10-15 years and more than half of those trials have not reported what was found in those studies. Since trial result (as the Tamiflu case has shown) is becoming such a contentious issue, even coming back to haunt the drug companies, can the latter take a proactive step and work with the Indian government to make provisions for reporting the trial results in the existing registry?


The current stalemate in clinical trials in the country, which is way behind its projected growth, has many downsides: patients are being denied treatment, new drug launches are delayed; clinical research industry is regressing and so are the ancillary businesses of laboratories and teaching institutes. If there’s one upside in this mess, it’s the opportunity to clean up our act; even go a step further to take the public in confidence by sharing the results.


In every press conference I hear a plea that this industry needs to create awareness and that the media has a big role to play. Certainly, but the industry should know one of the reasons daily newspapers don’t miss reporting a public interest litigation application is because it tells a story. The clinical research industry must also tell their story, with specific examples and data.


The Indian regulators have declared 2014 as the Patient and Animal Safety year. Let’s also make it a year of open data.



2 comments to “The many downsides and one upside of India's clinical trials mess”

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  1. How long do you think all the amendments to Schedule Y will take? It’ll be ages. ALso, how about specifically sharing data from Phase IV or post marketing surveillance? That’s where most companies and regulators merrily flounder.

    • Sandeep, you are right. It’ll take long. Industry folks say it could be at least a year. As for Phase !V data, indeed no drug company takes it seriously.A recent report in JAMA says that nearly 50% of the drugs approved by the US FDA in 2008, did not keep their promise of collecting or sharing post marketing surveillance data. In India you can imagine how strict the regulation is!

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