During hearings on alleged flouting of norms by pharmaceutical majors in conducting clinical trials on humans, the court had ordered the health ministry not to proceed with the clinical trials of 157 new drugs/formulations till a stricter regime was put in place.
An application filed by two Bhopal-based NGOs in the pending petition by “Swasthya Adikhar Manch” had alleged that survivors of the deadly poisonous gas leak from Union Carbide factory in Bhopal 30 years ago and being treated at Bhopal Memorial Hospital and Research Centre were being used as ‘guinea pigs’ for clinical trial of new drugs.
The health ministry listed three instances of norms being flouted:
* Inspection in 2010 on clinical trial of Telavancin by Quintiles Ltd: “Finding of the inspection of one clinical trial conducted at BMHRC showed some deficiencies like non-payment of compensation to the trial subjects for participation and non-reporting of serious adverse events within prescribed time limit.” The company was merely warned by Drug Controller General (DCG).
* Inspection in 2011 on clinical trial of Tigecycline by Quintiles Research Pvt Ltd: Finding of the inspection showed deficiencies like non-payment of compensation to trial subjects and non-reporting of serious adverse events in time. Again, the pharmaceutical firm was only warned in March 2012.
* Inspection in 2011 on clinical trial of Fondaparinux by Sanofi-Synthelabo Ltd resulted in identical findings – non-payment of compensation to subjects and non-reporting of serious adverse events and the DCG had again issued only a warning in March 2012.
From these three instances, it was clear that the pharmaceutical firms were not paying the mandatory compensation due to Bhopal gas disaster survivors, who had volunteered to be subjects in the clinical trial of new drugs and formulations.
The health ministry said of the 157 new drugs/formulations by global pharmaceutical firms which were directed to be re-evaluated by the apex court, the technical committee (TC) had evaluated 50 cases.
“The TC considered the details of the data relating to the safety and efficacy of the study drugs, details of protocols containing the objective of the studies, inclusion and exclusion criteria for enrollment of patients, treatment, assessment of safety and efficacy parameters keeping in view risk versus benefits to the subjects, innovation versus existing therapy and unmet need of the Indian population,” the ministry said.
“After considering the details, the TC recommended the continuance of these 50 clinical trials as they met all the relevant aspect