As per records of the Drugs Controller General of India (DCGI) in the Supreme Court, India approved 475 clinical trials for ‘new chemical entities' not used as drugs elsewhere in the world between January 2005 and June 2012. Further, the documents submitted by the DCGI claim that 11,972 adverse effects, excluding deaths, were reported in the period, with 506 of these being directly attributable to the trials. They put deaths from trials at 2,644 over the last five years.
The mainstream media reports from time to time displaying prominent headlines on the clinical trial deaths, have brought a bad name to the industry. And experts also lament that most of these alleged deaths are not even actually related with the trials. It is now clear that as far as opening a dialogue and establishing trust is concerned, there a big disconnect between civil society and industry.
While the civil society and media representatives say that its their duty to uphold the human rights, Dr Renu Razdan, chief operating officer, Max Neeman International feels that hype and sensationalism won't do any good. She says, "Unfortunately, the regulatory response to such media reports has been reactive making the e-regulatory process for clinical trials slow and uncertain. There is also a lack of transparency and consistency which is a cause of concern for the clinical research professionals in the country."
The availability of volunteers which was once feared to be a major concern is now no longer among the immediate issues. Few industry experts feel that word ‘volunteer' in this context is flawed in itself. "People participate for money. With high compensation there is no dearth of healthy subjects," remarked a prominent person from industry. He added further, "It was never and will never be a variable hampering clinical trial growth in India. India never lacked the availability of volunteers for doing trials. In fact, the availability of volunteers will always hinge upon the proper and scientific counseling of the patient to take up decision about being a part of clinical study or not."
India has always followed the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use- Good Clinical Practices (ICH-GCP) processes for informed patient consent. The document "Informed Consent Form" has all the detailed information written in layman and local native language for easy understanding and comprehending the information. Aaditya Vats, manager-regulatory affairs, Excel Life Sciences feels that informed consent is an education and information exchange process between investigator, the subject and their family. "The entire process of consenting gives adequate time and opportunity to the subject to consider all alternative options, consult with family, colleagues and physicians before taking the voluntary decision to participate in the study. Hence with the current documentation practice, if practiced, I don't see any reason for concerns over patient consent," he said.