The Union Health Ministry has decided to bring in more transparency into the approval and conduct of multi-centric clinical trials in the country. The Central Drugs Standard Control Organisation (CDSCO), under the Health Ministry, is to put up comprehensive information on global multi-centric clinical trials approved by the office of Drugs Controller General of India (DCGI) on its website on a regular basis.
The information includes the study title, protocol number, name, address and contact numbers of sponsors and collaborators, and an introduction of the disease and the nature of the study. The design of the study, its objective, location of the study and the contact information like name and address of the investigator and trial site would also be displayed. The list of countries where the trials are taking place simultaneously would also be given in the website.
The conduct and regulation of clinical trials had been a matter of intense debate during recent times. The just concluded session of the Parliament also saw members seeking more details on the government's policy regarding clinical trials conducted by multinational companies in the country. The updating of the website with details and status of the trials is expected to be a measure to build in trust among various stake holders including the civil society.
Regulations for conducting clinical trial in the country including multinational companies are prescribed under Rule-122 DA-122-E and Schedule-Y to the Rules. The Rules provide specific application form and relevant document requirements for seeking permission to conduct clinical trials. The data/documents are evaluated in consultation with subject experts.
Permission to conduct phase-I trial, including first time use in human beings, is presently not granted for new drugs developed outside the country. For drugs developed outside the country multi-centric clinical trails at phase-II and III stage are permitted after similar trial protocol has been approved by regulatory authorities of the countries where such drugs have been invented. Permission to conduct trials on new drugs invented outside the country takes into consideration the permissions granted by stringent ICH countries (viz. US, EU, Japan, etc.).
It should be noted that the amended Schedule-Y, which prescribes requirements for permission to conduct clinical trials, lays down stringent and specific procedures that need to be followed by sponsors, investigators as well as ethics committees. The amendment lays special emphasis on the modalities for obtaining informed consent from clinical trial subjects, and the language to be used for consent forms have also been prescribed. The Rules also require that 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 prescribed 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. These are also at par with very stringent international practices.
The ministry has conducted several training programmes with the support of WHO to make clinical research stakeholders aware of the new regulations and to impart them training on complying with the highest standards.
While it has been made mandatory that sponsors conduct periodic monitoring and audits of the studies, a process for conducting regulatory inspections has also been initiated. More than thirty subject experts from various medical institutions and CDSCO, have undergone a training workshop which was held in-coordination with Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, to equip them to carry out regulatory inspections of clinical trials, the ministry has informed.