A leading official from ACRO (the Association of Clinical Research Organizations) India has lashed out at the recent damning media coverage of that country’s clinical research industry, accusing news outlets and politicians of peddling “myths, misconceptions and misunderstandings” about the sector.

The regular flow of negative stories about the conduct and oversight of clinical trials in India, usually centring on lax enforcement of regulations or abuse of informed-consent procedures, has not abated, while a recent ‘sting’ by US-based TV news magazine Dateline NBC did not do the industry any favours.

Posing as a fictitious pharmaceutical company, Dateline NBC journalists 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).

For ACRO India vice chairman Ashish Dasgup, the recent stream of negative reports and government statements has been “so strong, it seemed like a procession of electoral result bulletins”, reflecting “abject ignorance about the CR industry, inaccurate reporting as well as political twists and turns”.

Clinical study participants, Dasgup claims, have seized the opportunity to report “false adverse effects, attempting to extort money and blackmail trial organisers”.

No progress otherwise

Without clinical trials, he argues, progress in medicines or other modes of treatment would simply stall – and that is the case worldwide.

“If we claim to have become guinea pigs, let it be known that across the world millions of human subjects from different nationalities were guinea pigs for the development of the medicines that people use today.”

India’s regulations in the pharmaceutical and clinical research sectors are “as stringent as in the aviation industry” and “in no way inferior to those in the west”, Dasgup insists. Inevitably, though, “irregularities” will occur. “Planes do crash, don't they? Does this mean the entire industry is bad and should be banned or maligned?” he asks.

Tighten up regulations

These experiences should prompt stakeholders to tighten up regulations and compliance, rather than the whole industry being tarnished by “negative propaganda”, Dasgup contends. But the authorities have responded to recent allegations by “making drastic changes to guidelines or by claiming that these trials were illegal”.

New draft guidelines on compensation for injury in clinical trials, for example, “are completely lopsided and do not leave any scope but for compensating towards anything that happens to the participating subject. Such guidelines will only suit bureaucrats and not the industry”.  

Moreover, claims that trials have been conducted illegally cast doubt on whether the current regulatory framework is functioning properly, Dasgup says. “The DCGI (Drugs Controller General of India) office that has powers to approve or reject trials should be empowered with authority and resources to become more effective than it is at present.”

The best and “most prudent” way to improve regulatory practice is for industry groups such as ACRO India, the Indian Society for Clinical Research and the Association of Biotechnology-Led Enterprises to work together with the DGCI and the Ministry of Health on improving compliance and introducing “regulations that will protect the interests of the participating subjects as well as promote the progress of science”, Dasgup concludes.