Clinical trials: Edicts and effects
Clinical trials and research in India seems to be in danger of getting mired in the quicksand of evolving regulation. And going by past experience, change is going to be the only constant in 2013.
Of course, regulations cannot emerge overnight. Framing our new drug pricing policy took almost a decade. And could see more tweaking, since NGOs like the All India Drugs Action Network are determined to challenge it yet again by filing an affidavit in the Supreme Court. While industry too was not too happy with the policy, the general consensus was that “it’s not perfect, but let’s move on”. Restrictive pricing apart, the decade-long process of updating the country’s drug pricing policy meant that in one sense, the industry was in limbo with players unable to plan long term strategy.
So are we in for a similar phase in the clinical trials and research segment?
Conducting clinical trials of new drugs in India is set to only become tougher, with increased regulatory oversight, as our Cover story (‘Clinical trials: More regulatory rigour on the cards’) points out. The regulator’s directives over the past few months have increased, but while the intent to safeguard patient safety is appreciated and for the most part welcomed by industry, the content of the regulator’s orders raises more queries than providing solutions.
Even those solutions already in place seem to be increasing approval timelines rather than streamlining the procedure. For example, since its inspectors were accused of not having the depth of therapeutic expertise required to judge applications for clinical trials, the CDSCO formed 12 committees of experts from government medical colleges and institutes and now acts on their advice. With one more layer added to the scrutiny process, decision making is delayed and approval timelines could go haywire.
While attempting to more clearly define the roles and responsibilities of the various links in the clinical trial process, from ethics committees to state drug control authorities, the Drug Controller General (India) seems to be sending out the message that each link will be held more accountable. It is the right tune and tone, but industry observers are wary of the nuances of these stated objectives.
From a media perspective, a clinical trials story never fails to make cover page or prime time TV. It has all the angles possible: human interest, business, legal, and ethical. And the coverage too throws up set phrases and images: poor Indian patients being treated like guinea-pigs, a profiteering and uncaring industry, toothless regulators, etc. Added to this mix are vigilante patient groups and it’s no wonder that the industry is worried about the long term impact. Regulatory oversight is welcome, say industry observers, but it should come with greater clarity and transparency.
And how does the regulator intend to monitor that the edicts are actually being followed, both in letter and in spirit? India’s drug regulatory framework suffers from a dearth of footsoldiers, i.e. drug inspectors, who are crucial to the implementation process. Will the regulator’s intent translate into sustained action down the line? Only time will tell.
Viveka Roychowdhury
Editor
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