As part of an effort to provide more certainty, India’s CDSCO (Central Drugs Standards Control Organization) has offered up a new compensation formula for trial participants who are killed or injured during a trial.
The draft formula -- which replaces an earlier iteration of the formula that was contested for allowing compensation due to product failures – is based on the patient’s age, risk factor for a disease and a base amount of 8 lakhs, or about $13,000. For patients whose expected mortality is 90% or more within 30 days, a fixed amount of about $3000 will be provided to patients.
Despite the changes, some industry experts don’t believe that industry will push for more clinical trials in the subcontinent any time soon.
John Lewis, senior VP of ACRO (Association of Clinical Research Organizations) told us, "It is doubtful there will be a major return of clinical trials to India until the political situation is settled and a new government has provided clear signs that research is again welcome in the country.”
He added: “Remember that, at its peak, India accounted for only about 3% of global clinical trial activity. So, while we remain optimistic about the future the current situation is still very unsettled."
In April, a committee under the Department of Health and Family Welfare considered different compensation formulas for serious adverse events that result in permanent disability, birth defect, chronic life-threatening disease or reversible adverse event. Most of those formulae are based on the number of days a worker is kept from his work, as well as the minimum wage per day of an unskilled worker.
Experts have until May 16th to comment on the new compensation formulae.
The changes come as the Indian Supreme Court called for drastic changes to the conduct of clinical trials following allegations of lax approvals and a higher-than-usual death rate. The government has since set up committees to take a closer look at how trials are approved and how to be fairer to trial participants.