The three phase clinical trials and subsequent regulatory procedures constitute 60 to 70 percent of development cost of a new molecule. Possible failures of drug compounds during the course of human trials is another huge risk the drug manufacturers take before the drug is launched in the market. It is in consideration of these factors, research-based pharma companies and their associations often claim that the overall cost of bringing a new molecule into the market ranges from 500 to 800 million US dollars. Neither anybody has verified this claim so far, nor any pharma company has ever come forward with the actual cost of bringing any particular molecule into the market. The argument here is that they need business secrecy. But the kind of secrecy the pharma companies maintain about the drug safety before and after its launch is not acceptable. Successful completion of clinical trials is inevitable and perhaps the most crucial part of any new drug development programme. Everyone in the industry and the government knows that there is no escape from this procedure. And as the trials involve several thousands of patients and healthy volunteers worldwide, necessary regulatory permission has to be obtained and elaborate procedures have to be followed.

The regulatory authorities routinely give permissions for trials after submission of toxicological reports, pre-clinical data and other relevant documents. But the question here is whether any monitoring of clinical trials is done by the regulatory authorities once the permission for clinical trials is granted. Unfortunately no such system exists in many countries including in India. There is no practice of providing the names of trial centres, investigators and human subjects to the Drug Controller General of India, according to the principal investigator who conducted clinical trials of ragaglitazar at NIMS in Hyderabad. In the case of ragaglitazar trials, Novo Nordisk has also gone on record that it has no details about the persons who have participated in the trials in India. This only shows that apart from the principal investigator, the only others who can have any knowledge about the trial participants and their conditions is the members of the ethics committee attached to the trial centre. How effective are these ethics committees is a matter for debate. Does the DCGI have a system of questioning the ethics committee? There has to be adequate transparency in the conduct of clinical trials as it involves lives of thousands of human volunteers who are usually not well informed. There is no system of checking how informed consents are obtained. Secondly who is verifying whether the patients understand the dangers inherent in such trials? The technical press needs to be involved in this process with access to meet the human subjects and the investigators. The responsibility of DCGI should not end with just granting approval for clinical trials to a drug company. The office of the DCGI must have complete knowledge of different stages of clinical trials and conditions of patients undergoing trials. It is high time the Indian Council of Medical Research and DCGI worked out a procedure to monitor clinical trials in this country.