India Tightens Clinical Trial Monitoring

India’s Drug Controller General is to increase monitoring of clinical trials following health activists’ pushing for tougher regulations in the Supreme Court, as concerns continue to arise about the safety and integrity of trials across the country.

Additionally, the Expert Committees will now be required to visit all clinical trials sites annually to verify the sites’ compliance with India’s Schedule Y regulations on clinical trials, Good Clinical Practice Guidelines and “other applicable regulatory requirements”.

The sites will also be required to keep records detailing the names, qualifications, and other relevant details of study investigators and clinical-trial sites falling under their jurisdiction, the Drugs Controller General says.

According to a report in India’s Business Standard citing a senior official in the Controller General’s office, if any discrepancies are found during the Expert Committee inspections, the regulator will take strict action against the company involved and may suspend the clinical trial.

The proposed changes follow allegations of pharma companies having brought thirty-three drugs to the market without a local trial, sometimes even marketing medication that had been banned abroad. Other accusations related to the industry exploiting underprivileged populations by enrolling them in testing without consent or oversight, leading to the General Drug Controller requesting that the Central Drugs Standard Control Organization inspects all clinical trial sites.

The stories made the news early last month, but met with response from the Indian Association of Clinical Research Organizations who said that the coverage was spreading “myths, misconceptions and misunderstandings” about clinical research.

The scandal was further fuelled by Dateline NBC journalists who, as a fictitious pharma company managed to find two low-profile Indian contract research organisations (CROs) apparently willing to conduct human studies on a compound chemically identical to the discredited COX-2 inhibitor Vioxx (rofecoxib).

This time last year, The Central Drugs Standards moved to tighten regulations pertaining to reporting of serious adverse effects. Under those changes, a SAE has to be reported within 14 calendar days accompanied by an appropriate covering letter, and the report must include a causality assessment by the rial investigator, and the medical monitor of the sponsor stating clearly whether or not the SAE occurred due to the pharmaceutical product under investigation. It must also include details of any compensation provided for the injury or death in the trial. If compensations are not paid, the SAE report should explain why.