India’s top drug regulator has proposed to change clinical trial requirements, by delineating more clearly the responsibilities for reporting cases of clinical trial-related injuries.  This decision, which would amend some clinical research-related clauses in India’s Drug & Cosmetics Rules 1945, follows a Supreme Court inquiry into the actual number of deaths and severe adverse effects (SAEs) caused to people during clinical studies.

The decision to amend specific clauses related to clinical research in India’s Drug & Cosmetics Rules 1945 comes in the wake of a fresh Supreme Court directive to the health ministry seeking details on the number of deaths and severe adverse effects (SAEs) caused to people during the studies. The Apex court order is the latest in a string of judgments on litigations filed by health NGOs and human rights watchdogs alleging irregularities in the way that clinical trials are conducted.

Recent lawsuits allege that contract research organizations (CROs) in India are not following current good clinical practices (cGCP) and other internationally agreed-upon norms, and that they are taking advantage of the lax enforcement of regulations in India’s fledgling clinical trial industry.

India’s Supreme Court, which recently mandated audio-visual recording of the informed consent process (see this column in the January 2014 issue of Contract Pharma), now wants to clear the air surrounding the reported figures pertaining to SAEs and deaths. Presenting evidence for a strong case of negligence, the litigation claimed that as many as 4,000 people either suffered from severe adverse events during clinical drug trials, or that they died in 2012 and 2013. In contrast, the government has maintained that there were 506 cases of SAEs and 89 deaths during this period.

In the ruling, the Court also asked the government to explain why financial compensation was not granted to the people seriously injured but alive, during trials. Companies paid compensation money only to the kin of people who died, in a few recent instances.

As a measure to address this issue, the drug regulator, under the health ministry, started circulating a compensation formula proposal in May for comments from stakeholders. The draft regulation proposes “quantum of compensation in case of 100% disability should be 80% of the compensation which would have been due for payment to the nominee/s in case of death of the subject.’’

Now, through modifying some clauses and inserting a few clauses in the current regulations, the government expects to bring more accountability in reporting of SAEs. The amendments spell out the roles and define the responsibilities of sponsors, investigators and ethical committees (EC) in reporting SAEs, in more clear terms.

The new proposal mandates that the sponsor of the trial must report SAEs to the regulator within 15 days of occurrence. In case of failure to report it in the stipulated time frame, the investigator has to furnish a sufficient reason for the delay along with SAE report. As far as EC is concerned, they can forward the report, along with their analysis and opinions regarding the financial compensation to be paid by the sponsor, within thirty days to the authority.

It also proposes free medical management to cases of trial injuries “as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is earlier.’’

Even as the health ministry continues its efforts to smoothen out the regulations, clinical research industry in India has started taking a beating. The number of approvals shrank drastically in the recent months as filing of new applications for sponsored trials significantly decreased. According to the Association of Clinical Research Organizations (ACRO) figures, industry-sponsored clinical trials registered a steep fall from 256 in 2010 to 86 in 2013. Members of the US-based ACRO accounted for nearly two-thirds of all industry-sponsored clinical trials in India.

CRO executives point to longer approval times and hostile regulatory climate for the slump. “Due to regulatory delays and uncertainties, and challenging regulatory regime, the number of clinical trials in India has declined by 50-60%,” said Dr. Arun Bhatt, president, Clininvent Research—a Mumbai-based CRO. Many of his peers share the view that inordinate delays through complicated procedures could prove counterproductive and would lead to the exodus of companies.

However, the Supreme Court judgment underscores a balanced approach to foster innovative research without endangering people: “Nothing should be done to stop development in the area of drug research,” the judgment states. “At the same time, though, the lives of people subjected to clinical trials must be protected.”