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.
No Christmas cheer here
The landscape for clinical trials appears bleak. At a media briefing in Mumbai yesterday, the Indian Society for Clinical Research (ISCR) said that until September this year, all of 20 global clinical trials (where India is one of multiple global sites) were approved by the CDSCO, India’s drug regulatory office. While this is four times as many as were approved in 2013, it is still a far cry from the hundreds that were given the nod when clinical research was at its peak in the country.
Essentially, 2014 was the year the industry felt the impact of 2013. And grappled with ways to mitigate it. Readers may recall that last year, a defensive government lobbed new rules and regulations governing clinical research like shells, in a bid to defend itself before the Supreme Court where a Public Interest Litigation (PIL) on injuries and deaths from clinical trials was being heard. You could almost visualise sponsors, their agents and ethics committee cringe and duck every time a communique shot out from CDSCO headquarters.
This year, the CDSCO issued further orders that sought to expand and add to last year’s efforts.
For sponsors, this no doubt felt more like a reckoning. A much-awaited amendment to the rules governing compensation for trial-related injury and death remained on paper. Sponsors had taken exception to these rules last year and requested modifications. Instead, the government went ahead with a new formula to ascertain compensation for trial-related deaths.
ISCR president Suneela Thatte stated that the compensation awards are several times the amount that the government pays out to victims of negligence by its own agencies and institutions. Abhijeet Das of LexCounsel which represented the ISCR in the Supreme Court said that the wide range of compensation considered appropriate by the CDSCO (Rs 4 lakh to Rs 74 lakh) is making it difficult for insurers to make their own calculations (presumably regarding liability and premia as sponsors typically insure trials to cover damages). To add to this, the formula is “provisionally final” suggesting it could change again.
Other rules such as the mandatory video-taping of the informed consent process is deterring subjects who value privacy from participating, said Dr C S Pramesh, surgical oncologist at Mumbai’s Tata Memorial, who has been an investigator in many cancer treatment trials.
As the new rules have so far have been a reaction to queries raised by the Supreme Court, sponsors now realise that unless the Court disposes off the PIL, uncertainty will linger over policy-making.
On the other hand, a government decision in 2014 to create an accreditation process for investigators, clinical research sites and ethics committees, is being viewed as a positive as it seeks to unburden the under-resourced CDSCO from doing hygiene checks and lets it focus on compliance on the ground during trials. It appears as though the process, led by the Quality Council of India, will focus on systems and infrastructure of sites, ethics committees etc leaving CDSCO free to inspect the actual conduct of trials. No other country that allows a significant number of clinical trials follows this two-pronged approach, Thatte said. But that is no reason why India should not do so, she added. However, this will be a long, drawn-out process and its implementation appears to be still under discussion.
In the New Year, the best that sponsors can hope for is that the PIL will be finally put to rest and no new ones will spring up to take its place, thus changing the context of their future engagements with the regulator.
Pharmacovigilance makes progress
Moving on to a different aspect of safety, in 2014, India’s national pharmacovigilance effort turned 3 years old under the Indian Pharmacopoeia Commission. More adverse drug reaction monitoring centres, mainly hospitals, were added. As of April this year, the number was 150 up from 60 in January 2013, according to the programme’s April newsletter. India’s contribution to the World Health Organisation’s side-effects database stands at 2 per cent, as of last year it said, on par with the UK (more recent numbers not available).
However, the challenge is to continue the effort, scale it up and rope in private doctors and hospitals. As of now, the majority of the monitoring centres (107) are government-owned while the majority of healthcare delivery is done by the private sector.
On the policy front, it was decided in 2014 that if two or more countries ban a drug for reasons of either safety or efficacy the regulator will review the drug in India. As things stand, it will be business as usual in this area unless there is another high profile drug withdrawal or ban for safety reasons in any developed market.
Pic sourced from Google Images