India Floats Draft Guidelines For Mandatory Registration Of CROs

MUMBAI - In a step aimed at tightening laws governing clinical research in India, the Central Drug Standards Control Organization has released its draft guidelines for registration of clinical research organizations in India. The guidelines have been approved by the Drug Technical Advisory Board but stakeholders will be consulted before the Drug And Cosmetics Rules could be amended to incorporate the new framework.

The guidelines come with the proviso that they will not conflict with rules applicable to clinical trials like the Indian GCP guidelines and Ethical Guidelines for Bio-Medical Research on human subjects by the Indian Council of Medical Research.

According to the new rules, every clinical research organization will have to register with the Drug Controller's Office and one of the strictures suggests that if the clinical research organization fails to comply with any of the conditions of registration, the licensing authority may suspend or cancel it for such period as deemed fit. However, if the clinical research organization raises objections within ninety days of the orders, the government may confirm, reverse or modify such orders. A registration will be valid for a period of five years, unless suspended or cancelled.

Kiran Marthak, head of Veda CR, said in the past there have been instances of illegal clinical trials in the country. "By registering CROs, we will only have serious companies taking up the job while the rest will either need to upgrade their quality standards or shake out," he said.

Marthak made the statement reacting to the strict criteria to be followed for the registration process. One of the points to qualify for the government approval is that the CRO shall be under the charge of a person who is responsible for the overall activities of the organization and who shall be thoroughly familiar with the investigational products, protocol, written informed consent forms and all related information. "This will make CROs more accountable when handling drug testing," he noted.

To prevent mishaps, the CRO will need to have adequate resources, along with qualified and trained staff for oversight of clinical trials, and the staff members are required to be trained regularly to update their skills.

In order to pin down the responsibilities of the sponsors and the CRO distinctly, the new rule states, "The trial related duties and functions transferred to and assumed by the CRO shall be specified in writing and properly quantified. The CRO shall ensure that the trials are adequately monitored and the trial related responsibilities transferred to it, partially or fully, by the sponsor are discharged effectively and efficiently."

The Indian government has taken decisive steps to regulate clinical trials in the country by registration of every clinical trial on new drugs. Earlier it was not mandatory to register the trials and few companies complied with the norms (Also see "Indian Clinical Research Industry Divided Over Mandatory Registration Of Clinical Trials From June 15" - Scrip, 26 May, 2009.).

- Vikas Dandekar ([email protected])