Updated on 16 July 2012
Dr Arun Bhatt put the Indian clinical research market at an estimated $300 million. He cited evolved healthcare system, manpower skills and the 20 percent of global disease burden in India as the reasons why India is considered for trials by clients. Calling the reports mentioning India as a hub of clinical research wrong, Dr Bhat added further that India holds only two percent share in the globally held clinical trials. However, he also talked about the decreasing Indian share. "India has to solve its regulatory issues and Drug Controller General of India (DCGI) has to be strengthened," added Dr Bhat.
Dr Shamsher Divedi said the gap between the industry and the people needs to be bridged. Talking about the need for harsher laws, Dr Divedi opined, "The deliberate acts of mismanagement on part of doctors need to be severely punished. There must be deterrents for the people who wrongly mould undesired people for trials as per their convenience. However it is to be noted that only 10 percent of doctors are involved in clinical trials."
Explaining the process of clinical trials, Dr Krathish Bopanna highlighted the importance of clinical trials to achieve the drug development. He said, "The drug development generally takes 800 million to 1.7 billion. Out of 5,000 to 10,000 targets, only 250-300 generally pass through screening into preclinical trials. After that the clinical trilas hardly have five left and finally it is one molecule that is either rejected or accepted by FDA. So, the trials process can hardly be considered simple."
The deliberations at the workshop concluded that the checks and balance need to be strengthened. Experts believed that while it is necessary to delist the doctors, institutes and organizations if they are found guilty of any wrong doings, it is also not fair to demonize the whole industry.
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