There are murmurs among clinical research industry executives that India’s health ministry will reexamine some of the clauses in the rules on compensation in case of clinical trial injury that it had notified in the Gazette of India in February and that had caused grave concern among trial sponsors.
This follows discussions between the industry and high-level ministry officials including the Director General of Health Services, clinical research industry sources said.
“They (health ministry) agreed that there have to be changes,” said one senior executive at a clinical research organisation (CRO) in Bangalore who was part of the talks. As to how these changes could be made, “The notification in the Gazette is a rule and not an Act and therefore clarifications can be given,” he said.
A drug industry consultant who attended a conference in New Delhi in March where officials from the drugs regulatory office were present corroborated this view. A high-ranking official said publicly that some regulations needed revising and that the chair of a newly-formed expert committee on clinical trials would address the industry’s concerns, he said.
Act in haste..
It is no secret that the government is on the backfoot ever since the Supreme Court began hearing a public interest litigation on subject safety in clinical trials and severely criticised it for its lack of oversight. “The government rushed through this (notification) before the next hearing in the Supreme Court which was to be in April (but is now in May),” the executive said.
It is a widely-held industry view that the consensus-building process that was entered into some months before the rules were notified, has been given short shrift. In meetings with industry, civil society groups, investigators and patient advocates, a middle-ground had been reached, say industry executives. Yet, this did not show in the final notification, they said.
Repent at leisure
What’s the industry fulminating about? Here’s a sample: A subject is now entitled to free medical management as long as needed in case of any injury suffered during trial. Drug and device companies that sponsor trials have argued that it is not explicitly-stated that the injury should be trial-related which exposes them to claims that have nothing to do with the trial – such as an accidental fall. (However, activists have said before that proving that an injury is trial-related is difficult and thus provides a loophole for sponsors to avoid paying up.)
Clinical trial-related injury is read to include the failure of the therapeutic product to provide the intended benefit. Companies have argued that this is, after all, the key purpose of doing a trial so it would be unfair to hold them responsible for what they have no control over and what they don’t guarantee.
Then, sponsors are held responsible in case of medical negligence or misconduct by the investigator (doctor conducting the trials) and liable to pay compensation to the subject. Again, companies argue that they cannot be penalised for someone else’s mistake.
Safety is a deluge of paper
Since February, the health ministry has also made it mandatory for ethics committees (ECs), whose job is to ensure that trials are ethically designed and conducted with due regard to subject safety, to obtain registration from the drugs regulator before considering trial proposals.
ECs have been given 45 days (ending earlier this week) to submit a checklist of documents to the office of the Drugs Controller General of India (DCGI). This includes information on protocols reviewed, and minutes of meetings held, among other things.
“ECs can review new proposals only after registration,” said Dr Nandini Kumar, a bioethician and former deputy director general of the Indian Council of Medical Research who is an EC member. “EC meetings will be held only for ongoing trials (until then),” she said. This has applied the brakes on all sorts of trials including bioequivalence studies for generics, she said.
There is no word on when a registration will actually be issued. “(EC registration) had to happen some time or the other,” says Dr Kumar. “But there has to be a time slot for this.” She believed that the DCGI’s office has received at least 300 applications to register. But “noone knows what is the time period for which various documents have to be submitted,” she said.
Some are doubtful of when the changes will occur. “I believe anything that has to happen will happen only after the Supreme Court hearing,” said Arun Bhatt, president of Mumbai-based CRO Clininvent Research. “Personally, I’m not so sure you can change a gazette notification.”
Bhatt said that sponsors are still interested in India given the size of the population. “They still want to come and meet the government,” he said.
Whether that will amount to anything is to be seen.
Pic sourced from http://www.clcker.com