The three phase clinical research lasting for three to four years involving thousands of human volunteers in multi locations is the most costly part of new drug discovery for a pharmaceutical company. Any of the potential drug candidates can be abandoned during the trial period if the adverse drug events are beyond the acceptable limits. It is a high risk activity requiring millions of dollars and pharmaceutical companies usually make sure that trial reports reaching the regulatory authorities are favourable. No new drug can be approved for marketing without submission of trial reports and their scrutiny by the regulatory authorities. India has emerged as an attractive destination for clinical trials since 2000 as the MNCs realised that the country has a diverse range of patient pool and a relative cost advantage for human studies. Apart from top MNCs like Pfizer, GSK, Novartis and Novo Nordisk, a large number of contract research organizations had thus got into clinical trials in India for more than ten years.
While India established itself as a global destination for clinical trials, unethical practices in this business also started emerging slowly. This was mainly in matters like patient recruitment, taking informed consent, bypassing ethics committees,submission of trial data,etc. The weak regulatory system governing clinical research in the country has emboldened the companies and CROs to do this. It is this situation that caused several deaths and fatal injuries during trials in the last three to four years. An inquiry conducted by the Union health ministry in May 2011 thus revealed that 671 deaths occurred during trials conducted by different companies in 2010. And only in three cases, some compensation was given to the relatives of the victims by the pharma companies or CROs. It is from here the problems started for clinical research in the country. The Supreme Court took a serious note of this state of affairs and had made some scathing remarks on the health ministry’s neglect in this matter. The health ministry subsequently notified the rules and procedures for fixing compensation to the victims of trials giving legal backing to the existing guidelines. The rules thus notified by the government under Drugs & Cosmetics Rules had put the DCGI as the final authority in the matters relating to the compensation in the cases of deaths and injuries during trials. DCGI also became strict in granting approvals for clinical trials. In case of compensation to victims of trials, MNCs and CROs should not have reasons to complain. That is a standard practice anywhere in the world. What is actually disturbing the pharma companies is the reluctance of DCGI to grant approvals for trials. And it is a fact that from 2012 number of approvals for drug trials came down sharply. This should not have happened. What is required is effective monitoring of trials and that must be possible now by making registration of ethics committees compulsory. The office of the DCGI should not, therefore, unreasonably hold up granting of approvals for trials.