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Huge growth in clinical trials in India
 
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November 24, 2008 18:13 IST
Clinical trials in the country have witnessed a tremendous growth in recent years, a top government official said.

"In 2005, around 100 clinical trials had been approved in the country by the Drugs Controller of India (DCI). In 2006, it increased to around 150 and to 240 in 2007. In the current year, around 450 have already been approved," Joint Drugs Controller of India, A B Ramteke, said.

Speaking on concurrent lines, S P Vasi Reddy, chairman and managing director, Vimta Labs [Get Quote], said that India offered a platform for clinical trials as "nobody wants to compromise on quality as against the cost."

Clinical trials are conducted to ensure the safety and efficacy of newly-invented drugs or devices. These trials can take place only when a satisfactory information or data has been collected on the quality of the product.

"When a drug or a molecule is invented, it has to go through the Drug Development Process. First, it is always performed on animals. If the process does not satisfy the safety aspect, it does not go to the human beings for trial," Ramteke said.

If a drug is invented in India, it has to go through different phases of clinical trials. "Phase I trial, which is conducted on human beings, is done to test the safety aspects of the drug. Then is the Phase II trial where dose-designing is conducted in which researchers assess how well the drug works, whereas in Phase III, a large-scale trial is being conducted," the DCI chief said.

If the results found are not satisfactory, the trial stands null and void and does not proceed further, he said.

Speaking on the duration of a trial, Ramteke said that it depended upon the dose. Some have a short-life like antibiotics. They take a week to show their efficacy whereas some drugs such as anti-diabetics are for life-long.

The patients on whom the trials are conducted are selected from hospitals where doctors of a particular hospital are the investigators, he said. Once the trial is conducted, protocols are made and then publicised in the market, Ramteke added.


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