Contract research organizations (CROs) will now have to register with the body that regulates clinical research in India if they want to continue partaking of the boom there.

India's Central Drug Standard Control Organisation (CDSCO) has issued Rule 122 DAB on “Registration of clinical research organisations for conducting clinical trials.” After its 45-day comment period, the rule will be woven into India's Drugs & Cosmetics Act of 1945 as Schedule Y-1. Here's the document.

Those already doing business there and eager for the market to mature say this is a good thing.

“The idea is one that's very important for the industry in India,” says Dan McDonald, VP of business strategy with Chicago-based Excel Life Sciences, a trial management and site support organization that works exclusively in India. “India's been such a hot market, there have been so many CROs entering the space, but no official regulation of any of them. The government there needs to know who's conducting these trials and testing medications on the public. It seems like an important and obvious next step in the industry's growth.”

Among the criteria is a requirement that CROs be under the charge of a person “thoroughly familiar with the investigational product(s), the protocol, written informed consent forms or other information provided to the subjects, the standard operative procedures by the sponsors, GCP guidelines and other rules applicable to the conduct of clinical trials.”

Science First

Why was that necessary? Kohkan Shamsi, India-based CRO Manipal Acunova's CEO for the U.S., says regulators were likely thinking of CROs owned by investors and perhaps not as focused on the science as they should be. He points out that, as part of Schedule Y-1, regulators want to see the curriculum vitae of top management. “They want to know the quality is there, and they want that in writing,” says Shamsi.

The proposed rule goes on to stipulate that CROs have adequate resources, and that they regularly train staff to update skills. CROs' duties for each trial must be specified in writing. Schedule Y-1 also imposes responsibilities for record-keeping, and requires the CRO to show a copy of the contract between itself and the sponsor.

Open To Inspection

McDonald notes that Schedule Y-1 isn't meant as a barrier to the market, but rather as a way for CDSCO to keep track of which firms are actively conducting research. Still, the draft guidelines do have some muscle; they require that CROs have no objection to an in-person inspection of the premises and any pertinent documents, and they state that the regulator will have the power to suspend or cancel the license if the CRO isn't complying with the guidelines.

Licenses are valid for five years. Schedule Y-1 covers all organizations, individuals, institutions and companies that have responsibility for initiating, managing or coordinating a clinical trial—excluding investigator sites. But sites may be covered next, as could ethics committees, says Shamsi. The regulation of both is being discussed in India now.

by Suz Redfearn