Early this month, Pharmabiz reported about a move by the Indian Council of Medical Research to undertake a study on the status of Institutional Ethics Committees operating in the country. As per the plan, ICMR is expected to send expert teams to IECs attached to various hospitals and research institutions to review their functioning and suggest any corrective measures required for their improved working. ICMR's objective is to introduce an accreditation system for IECs. An accreditation system for IEC is certainly a well-meaning move. As a first step in this regard, ICMR has commenced a survey of these institutions by sending out a detailed questionnaire. So far, only 250 research institutions have responded to ICMR. And there are many more research organizations across the country, which have not responded. Such a lukewarm response from IECs is not surprising considering the current state of clinical research administration in India. It is in a total mess. The DCGI routinely gives permissions for clinical trials after submission of toxicological reports, pre clinical data and other relevant documents. After that there is no proper system of monitoring or reporting of what happens during the three phases of clinical trials.

An IEC in a research institution is expected to be regularly consulted by the principal investigator at each and every stage of clinical investigation. This rarely happens with IECs in India. IECs are expected to know the names of trial centres, investigators and human subjects. If the company, conducting the clinical trials, is holding back such information, IEC should be reporting it to DCGI. Unfortunately that has not been happening. One such case is that of ragaglitazar. The principal investigator who conducted ragaglitazar trials at NIMS for Novo Nordisk in 2002 went on record that there is no practice of providing names of trial centres, investigators and human subjects to DCGI. Novo Nordisk also said then it did not have any details about the persons who participated ragaglitazar trials in India. This is only one such instance. Usually, informed consents are taken from the patients without their understandings what drugs are tried on them and their consequences. A majority of the subjects undergoing trials in India are either illiterate or semi literate. In short, IECs have not much say in the whole business of clinical trials as most of the companies try their best to maintain high level of secrecy. What is more important as a regulatory measure is to empower IECs.