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 the industry can force in the coming months and years.

In 2011 and 2012, the sector (loosely defined for the purposes of this post as all those with a business interest in the conduct of clinical research such as sponsors and their outsourcing agencies) faced its worst nightmare.

Allegedly unethical drug/vaccine trials were unearthed in various parts of the country, Parliamentarians demanded answers, a defensive regulator pedalled down on trial approvals, a public interest litigation (PIL) on illegal drug testing led to strictures by the Supreme Court and media coverage was relentless.

Clinical research companies say this has led many sponsors to pass over India as a destination for trials in favour of other locations in Asia and eastern Europe.

Yet, at least some parts of the sector are not about to give up without a fight.

“We have to survive (through this) period of uncertainty,” said Krathish Bopanna, president of the Indian Society of Clinical Research (ISCR) at the Society’s annual conference held in Mumbai last week.  ISCR members include pharmaceutical companies that sponsor trials and contract research organisations that work on their behalf.

Noting that about 15,000 to 17,000 people are currently employed in clinical research in the country, he added, “we don’t want to lose these skill sets.”

What’s it doing to undo the damage?

Let’s talk

For starters, talking. On the cards, said Suneela Thatte, member of the ISCR Executive Committee, is continued and focused communication with the media expanding over time to likely include patient groups and medical students.

“Most of us were scared to go out and talk,” said Bopanna. “But when you don’t give complete information people think something’s fishy.”

Greater transparency is most definitely called for.  The industry voice has been largely absent from most recent reportage on clinical research controversies.

But will the communications gambit be restricted to general discussions on clinical research coupled with hand-wringing on unfair media coverage, and uninformed activism? Or will it include proactive and meaningful information-sharing by ISCR member companies in the event of regulatory warnings, trial mishaps, and other potentially controversial issues? That remains to be seen.

Up until recently, the accent has mostly been on the former.  However, at this  conference, executives signalled what appears to be an intent to be more flexible. In response to media queries on pending litigation in the Supreme Court, ISCR executives helpfully produced a Court order issued the day before, with their interpretation of it and thereafter fielded questions. The unscheduled press briefing was arranged at a moment’s notice.

The recent crises, it appears, have also forced players to look inward. Some companies have lately begun to maintain a database of blacklisted investigators, said Thatte. Ethics committees are being trained using practical case-studies rather than on theory alone. This should help prepare them better to address ethical questions that might get thrown up during the course of a clinical trial.

In parallel, the sector faces a far more vexing issue –  inspiring confidence in the regulatory system. This holds the key to its long-term survival.

Two to tango

Regulatory functioning has been the weakest link in the chain for several reasons. One, the Central Drugs Standard Control Organisation (CDSCO), India’s equivalent of the US FDA, has always been inadequately staffed to conduct inspections and audits as a result which these are hardly ever conducted.

Two, the CDSCO  was laidback on the issue of compensation in the case of trial-related injuries and deaths until the controversies erupted. Three, like every other government organisation, it has shown an unwillingess to proactively share vital information (including data on inspections, findings, and trial-related injuries) democratically and with appropriate context. Four, the machinery in the states is even worse off – state drug inspectors posssess neither the mandate nor the expertise to regulate clinical trials.

The absence of sufficient regulatory oversight has made it easy to believe that clinical trials are conducted without due regard to laws or subject safety. Indeed, the Supreme Court has largely dwelled on this circumstance.

On the flip side, the CDSCO’s response to criticism – the appointment of so-called expert committees to approve every trial – has delayed the approval process. And players claim this is not because of increased rigour but simply the failure of these committees to meet.

ISCR’s Thatte observed that the forum planned to work closely with the CDSCO to push for a force of inspectors who will regularly inspect trial sites and to facilitiate their training by regulators in more advanced countries. It is also keen that new rules on ethics committee registrations and compensation for trial-related injuries and deaths be swiftly notified as a follow-through of assurances that are given in Court.

This sort of engagement is most definitely called for. After all, a proactive public relations strategy cannot make up for regulatory inaction or indifference.

But it takes two to tango. A lot now depends on the next steps that CDSCO and the ministry of health to whom it is accountable will adopt to set things right.

There is no doubt that unless this weak link is strengthened, the sector might repeatedly reach flashpoints that jeopardise its very survival.

Pic courtesy photostream of US Library of Congress on Flickr


2 thoughts on “Clinical trials in India : Can industry push regulator to act?

  1. Gauri, great article. we all need to join hands and work ethically. Sites need more regulators than depending on the government.


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