In an effort to improve the nation’s reputation for inadequate care and compensation of clinical trial victims, the Indian government recently laid out a structured new patient compensation plan. With this plan the government announced that there will be stricter enforcement of the new regulations such that violation will result in cancellation of the associated study. In addition, all clinical trial participants are entitled to medical treatment and financial compensation in the event of permanent injury or death, the details of which are to be decided by the Ethics Committee responsible for approving the trial.
The Indian Government’s New Patient Compensation Plan
India’s clinical research framework has made it an attractive outsourcing location for multinational bio-pharmaceutical companies over the past few years. Higher recruitment rates, patient diversity and lower clinical research costs are among the factors which have attracted foreign sponsors. Many of the regulations favor outsourcing: 1) In January 2005, foreign pharmaceutical companies were permitted to conduct trials in India in the same phase that they were being conducted abroad. 2) In 2008, the clinical trials service tax was withdrawn.
But the number of deaths resulting from participation in clinical studies has reportedly increased significantly in India, especially between 2007 and 2010. As a result, there has been much criticism, and the Indian government has responded by implementing reforms.
Effective as of January 30, 2013, the new plan aims to promote stricter oversight and enforcement of clinical research regulations. However, many contract research organizations working in the country believe that the new regulations will make India a less desirable outsourcing destination. They argue that the industry will choose to go elsewhere as a result of these changes, assuming that there are serious problems with India’s clinical research structure.
A number of organizations associated with the industry do not agree with the shifting of the decision to the ethics committees. Many argue that ethics committees lack the scientific and medical knowledge necessary to identify the cause of a serious adverse event leading to injury or death. Thus, they are not qualified to determine the level of compensation. Moreover, some of the deaths in India may have been associated with pre-existing conditions rather than the experimental treatment itself.
As India attempts to boost its biotech industry, the clinical research sector is among the government’s top priorities. If it is to succeed it must balance patient concerns along with those of the pharmaceutical industry.
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