CROs operating in India see the industry picking up speed after several months where it slowed down following a slew of new regulations intended to safeguard the rights of human subjects participating in clinical trials.

In July, India’s newly-formed two-tier approval committee under the Indian Health Ministry cleared 41 submissions in one go, from the long-pending list of trials awaiting approval. Some observers see this massive approval as an attempt to right the course of a sector that had been, reportedly, tipping toward a crisis.

India’s recent regulatory clampdown had resulted in a drastic drop in trial approval rates. The regulatory authority only approved about two dozen studies during the past year through June 2014, according to the Indian Pharmaceutical Alliance (IPA), an association of Indian pharmaceutical companies.

The heightened regulatory activity was triggered by a series of new rules following a judgment by the Supreme Court of India ordering the government to ensure patient safety in clinical research in early January 2013.

These new regulations made mandatory the audio-visual recording of the entire process of obtaining informed consent.  They also restricted total number of studies that an investigator can undertake to a maximum of three at a time. Authorities said that the rules were necessary to make the studies using experimental drugs in humans more transparent, and to bring credibility into the system. But companies complained that these directives were either lacking in details, or arbitrary.

CROs have been under fire in India for overall lack of accountability, and for failing to protect clinical trial subjects adequately, and for lack of accountability, since reports came out alleging an unusually huge number of injuries and deaths during clinical trials.

As they face increased oversight, many CROs have maintained that they followed clinical trial regulations, and that they have been blamed for the acts of a few errant companies.  Recently, a number of domestic and multinational CROs announced that they would shift their clinical studies out of India entirely, as they found the regulatory climate growing increasingly hostile by the day.

Approval delays had already been a major concern for CROs in India.  Companies seeking permission for clinical studies often find themselves in unpredictable situations. The process of granting approval may take more than two years. In addition, there is no way to track the status of approvals after filings,  some CROs have said.

With its new measures, the Indian government appears to be addressing these complaints. The proposed guidelines give the regulator a strict timeframe of six months for granting approval for new filings. Moreover, the companies will now be able to check on the status of their applications and also discuss with the regulator the details of the trial during the review period, after paying a fee.

The Expert Committee on Clinical Trials set up by India’s Health Ministry also recommended the formation of a panel of experts to evaluate the new drug applications to avoid any bias during the review process.

Online Submissions of Forms and Clinical Data Repositories Planned
India regulatory agencies are also planning to introduce a system to enable online submission of various clinical trial forms and applications. They have circulated a formal proposal to stakeholders for comment. This would create a common repository of clinical trial information such as sponsor/CRO; investigator; ethics committee and patient. The system is expected to go a long way to streamline the process of data submission and build credibility for the data generated. It would allow users to call up all the details pertaining to any clinical trial in India by simply entering avunique identification number. 

New steps on the part of the government would help bolster the confidence level among global as well as Indian players and regain the momentum in country’s clinical research sector, said Professor Ranjit Roy Chaudhury, who heads the Expert Committee.

Representatives of Indian CROs say that they hope that the government has finally begun addressing some of the concerns they had raised in the past.  However, winning back full trust could take several months, as criticism of clinical research continues in the media and among activists.

CRO executives have said that India’s government should also direct more of its efforts to creating public awareness of the importance of clinical research, if they are serious about bringing the country’s fledgling clinical research industry back on track.