The Rajasthan Government has argued for greater involvement of State Governments in the drug trial process along with online monitoring of trial subjects and provision of immediate medical care in cases of Serious Adverse Events (SAEs).
The State made these and other recommendations during a meeting of Chief Secretaries/Health Secretaries of State Governments and Administrators of the Union Territories, held in New Delhi on August 13, 2013, a copy of which was accessed by The Hindu recently.
The meeting was convened by the Union Ministry of Health and Family Welfare in order to discuss all aspects concerning the legal framework for strengthening the regulation of clinical trials in India.
The Supreme Court (SC) had directed the Union Government to hold such a meeting in response to a Public Interest Litigation filed before it by a group of Indore-based medical rights activists.
According to the State Government's deposition before the SC in the PIL, drug trials claimed 95 lives during the last eight years in the state, along with 291 cases of serious adverse events.
One of the most important suggestions made by the State Government pertains to medical care to victims of Serious Adverse Events. SAEs comprise undesirable, even life threatening, experiences for trial subjects as a result of a drug trial, including death, disability or permanent damage and hospitalization, among others.
In this regard, the Rajasthan Government has argued that “immediate medical care for persons suffering from SAE should be provided by the Principal Investigator (PI) and it shall be his sole responsibility. This information should be available on line”.
“The suggestions made by the Rajasthan Government are the most comprehensive among all State Governments and some of them, such as the one making the PI solely responsible for providing medical care to SAE victims will go a long way in protecting the rights of trial subjects,” says Indore-based medical rights activist Anand Rai.
Among other suggestions made was the presence of a State Government representative on the Ethics Committee and detaching of the Ethics Committees from the hospital/institute where trials were being conducted.
Ethics Committees are tasked with regular review and monitoring of clinical trials and with ensuring that the rights of trial subjects are not violated.
“The State government must also be involved with regard to registration of sites / hospitals / Institutes for the conduct of trials, the nature of trials and the criteria for the selection (of trial subjects),” the Rajasthan Government suggested in the meeting.
The Government also suggested putting in place an “accredited system for selection of Principal Investigator” and restricting the number of trials that could be conducted by a single investigator.
In the meeting, the Madhya Pradesh Government recommended that all death cases during drug trials should be subjected to post-mortem examination to determine the (precise) causes of such deaths.
Other State Governments suggested reforms in the procedure for the inspection of clinical trials to allow State Government officials to inspect trials jointly with the Central Drugs Standard Control Organization.
States also suggested the creation of clinical trial cells at the state-level for sharing of information between the centre and the states, and training state regulatory officials about the drug trial process.
