By making registration of human trials mandatory from June 15, 2009, clinical research has become more accountable in the country. The measure by the Drugs Controller General of India (DCGI) office is expected to bring more transparency to this critical part of drug research. Clinical research organizations have positively responded to the compulsory registration as it can also curb malpractices in human trials.

The trials have to be registered by any one of the stakeholders: sponsors/CRO/Institutions/Investigators/Ethics Committee. If a trial is not registered, volunteers or patients cannot be recruited. Clinical Trials Registry- India (CTRI) is recording every study taking place in India along with details of new drugs, therapies, surgical procedures and medical devices.

The issues of credibility, quality and reliability of the trial are critical for India as the country is carrying out over 700 human studies. This has also put pressure on DCGI to raise the benchmark of Indian clinical trials industry which is currently valued at $1.58 billion with 120 CROs. Some of the CROs are independent entities while others are attached to hospitals.

This was a much awaited regulation in this sector. There is no room for fraud, chaotic and disorganized work process. "We now need to see how exactly DCGI will monitor the CROs through the CTRI," stated Dr Ramananda Nadig, president and deputy dean, Clinical Research Education and Management Academy (CREMA).

The registration of clinical trials not only will streamline human studies in India but it compliments the clinical trial governance like that of the US. With a strict regime enforced, CTRI has automatically created a paradigm shift in the conduct of clinical trials. From stringent adherence to quality standard operating procedures, qualified-trained principal investigators and well equipped sites, every CRO is now gearing up to ensure the parameters are achieved, stated Shekhar Gupta, chief operating officer, D2L Pharma Research Solutions.

CTRI registration is a license to conduct a trial. Global companies will have the added confidence and no longer show restraint and apprehension to off-load human studies to India, added Gupta.

According to Dr KH Ram, managing director, SMO Clinical Research (I) Pvt Ltd, the CTRI is viewed as platform to eliminate unethical practices. This dedicated registry to monitor clinical trials was the best thing that could happen. The focus is only on ensuring ethical practices and patient safety which are the cornerstones of success for a CRO.

The need for regulation in this sector was felt ever since deaths were reported during clinical trials at reputed medical centres in the country. As India has emerged as a hub for clinical trial, a credible regulatory framework was needed to enhance the growth of this industry. The registry will improve the country's image which has been tarnished with cases of alleged unethical and sub-standard practices during the conduct of clinical trials.