Clinical trials may rise as drug regulator eases rules

The federal drug regulator has eased norms related to pharmaceutical research, a move that may boost the number of clinical trials but could also raise concerns on patient safety. 

Drugs Controller General of India (DCGI), in a recent notification, said an investigator or researcher can undertake as many trials as approved by the ethics committee instead of the present cap of three. The regulator has also relaxed norms for hospitals or clinical sites undertaking such trials. Through a separate notification, the DCGI has revised the rule that prohibited any hospital with less than 50 beds to take up a trial. Under the revised norms, the ethics committee has been empowered to decide whether a site is suitable for a trial irrespective of its bed capacity. It suggested the site should have "emergency rescue and care arrangements". 

The ethics committee is a panel of experts which examines the proposal of a pharmaceutical company or a researcher to conduct clinical trials or human experiments for new medicines. Following random clinical trials and increasing number of deaths during such experiments, the government had earlier imposed a restriction of not more than three clinical trials to be conducted by an investigator. 

The number of clinical trials in India went up rapidly around 2008­09. According to data available from the Central Drugs Standard Control Organisation (CDSCO), around 65 trials were approved in 2008, whereas it jumped to 391 in 2009 and 500 in 2010. However, following the Supreme Court's intervention, the approvals dropped drastically from 2011 onwards. 

The latest changes has cheered the industry. "Ultimately what this translates into is qualitatively better clinical trials as decisions will be guided by which investigator or site is best suited for a particular trial," Indian Society of Clinical Research president Suneela Thatte said.