A team of experts from the Indian Council for Medical Research (ICMR), All India Institute of Medical Sciences (AIIMS) and Central Drugs Standards Control Organisation (CDSCO) are planning to review the existing GCP guidelines on February 24, 2006 at New Delhi.
According to industry sources, the experts will look into aspects such as ethical issues, introduction of stricter regulations, patient care resource and specific laws for informed consent. There are serious plans for creating a minimum law to govern issues relating to informed consent, sources said.
GCP compliance is still in the evolutionary stage and will improve as the industry will mature in the coming years, industry experts said.
The amended Schedule Y prescribes requirements for permission to conduct clinical trials, lay down stringent and specific procedures that need to be followed by sponsors, investigators as well as the Ethics Committees.
The amendment lays emphasis on the modalities for obtaining informed consent from clinical trial subjects, and the language to be used for consent forms has also been prescribed. As per the rules a prior approval of the Institutional Ethics Committee has to be obtained before undertaking any clinical trial in the country.
Membership criteria as well as conduct of the Ethics Committee meetings have also been recommended in the amendment. The revision has been made in consultation with experts including experts from ICMR, with the basic intent of making regulations in line with contemporary global standards for clinical trials.
The government has brought out detailed guidelines on Good Clinical Practices (GCP), which are also required to be followed during the conduct of a trial. Conducting periodic monitoring and audits of the studies by sponsors is made mandatory. A process for conducting regulatory inspections has also been initiated.