Many transnational contract research organizations (CROs) planning to open clinical trials in India do so often wary whether they’ve got the required approvals. Their apprehension on securing timely clearances has increased of late, in light of reports suggesting stringencies in the newly imposed regulations for conducting clinical research. 

India started revamping the rules governing clinical research following a stricture from the Supreme Court in 2013. The apex judiciary ordered the health ministry to urgently review the regulatory oversight for clinical trials after several lawsuits alleged serious gaps in the conduct of human studies in India.

Finding themselves in a state of flux in the aftermath of the regulatory “streamlining” process, the country’s CROs expressed concerns that several of the requirements in the new norms are too tough to deal with. They feared such bottlenecks could stall the industry’s growth. Falling numbers in registered clinical trials in the subsequent period also lent support to CRO arguments.

Government’s latest move is seen as a response to the industry seeking to allay the fears.

In August, the Drugs Controller General of India (DCGI), the country’s top regulator, came out relaxing some of the rules through a series of announcements. The DCGI, according to the circulars published on the official website, decided to remove certain restrictions after holding rounds of discussions to deliberate stakeholders’ concerns and the way forward relating to some issues on conduct of clinical trials in India.

Firstly, the regulator did away with a requirement that limited an investigator from conducting more than three trials at any given period of time. DCGI, instead, delegated the power to the institutional ethics committees to decide on the numbers after examining the risk and complexity involved in each study.

Clinical research firms were intensely lobbying to remove the “not more than three trials” clause arguing that restricting the number of studies for an investigator was not justified in the interest of clinical research in the country. Since clinical studies vary considerably in their scope and purpose, such hurdles would only result in improper utilization of resources.

DCGI’s second release pertained to a condition specific to trial sites. As per the prevailing rules there must, at least, be a minimum of fifty beds to qualify the site for conducting clinical research. In other words, no hospital with less than fifty beds can undertake clinical studies. DCGI scrapped this clause and shifted the responsibility again to the ethics committees to judge whether a site is suitable or not for clinical studies irrespective of the number of beds.

CROs often find fulfilling the fifty-bed requirement really hard, especially, in semi-urban and rural Indian settings where hospital infrastructure continues to be a challenging issue.

However, the regulator suggested that the site should not compromise on all the other facilities required for the particular clinical study including emergency rescue and care arrangements, even though the number of beds is less.

Likewise, a no objection certificate from the DCGI was mandatory for the firms running clinical research in India every time they added new trial sites. Direct NOCs from the regulator was essential for addition of investigators, as well. Many times, CROs expressed their frustration of going up and down whenever a new site or investigator was found necessary. Time and effort usually wasted to meet this apparently simple requirement was too much.

Removal of the NOC practice for addition of sites or investigators has been the third major decision the authorities made. The ethics committees are empowered to approve proposals for addition of sites and investigators after proper due diligence is performed and without the need to seek the same from the DCGI. But the circular did mention that the applicant would inform DCGI about such addition or deletion. If the concerned firm did not receive objection from the DCGI, “it would be deemed to have concurrence of Central Drugs Control and Standards Organization,” the DCGI’s office.  

India’s fresh effort to bring clarity in its regulatory approach to clinical trials could help lift the lurking uncertainty. However, the government needed to re-emphasize that increasing transparency in the regulatory structure would ensure speedy and timely clearances, experts said. 

Demand for Indian CROs is expected to grow in the next few years as the global market is forecast to nearly double from current levels. The worldwide CRO market may reach $59.42 billion by the end of the decade with a growth at constant rates of 9.8%, according to analysts at Zion Research, a U.S. consultant firm.

India’s vast population base, fairly lower cost of operation and improving health care infrastructure, make it fully equipped to grab new opportunities. However, the industry should work with the government to continue efforts to provide an enabling environment to achieve this.