After strict regulations governing clinical trials were implemented in January last year, the quantum of tests conducted across India have reduced by less than 50 per cent.
While from 2005 to 2012, there was steady increase of commercial clinical trials being commissioned by the pharmaceutical companies after a nod from Drugs Controller General of India (DCGI), the number has seen a steep decline since 2013, doctors at Tata Memorial Hospital (TMH) in Mumbai said.
Tata Memorial Hospital, along with Indian Society for Clinical Research (ISCR), had organised a joint meeting to address the pros and cons of clinical trials on May 20, which is marked as the International Clinical Research Day.
"In 2012, over 200 commercial clinical trials had been going on in the country, which trickled down to double digit numbers in 2013 and further declined to somewhere close to single digit numbers in 2014," said Dr C Pramesh, researcher and professor, thoracic surgery at TMH.
A 49-year-old former breast cancer patient, who was part of a five-year-long clinical trial at TMH, said, "The new drug came as a boon for me. I was put on drug trials and recovered from cancer eventually. The drug was not commercially available but being in trial has given me a new lease of life."
Clinical trials are prominently being conducted in the fields of cancer, respiratory diseases and diabetes at the moment.
The DCGI came up with a new draft of laws which mandated that compensation be provided in case a patient suffers from an adverse event. Also if a new drug failed to have any therapeutic benefit, it would entitle patient to compensation, said the DCGI.
Further, the patient has to be remunerated to be inducted in the trial. The scientific fraternity has not agreed with DCGI's mandate.
"This is inducement to the patient and it's unethical. A patient should be part of the trial simply because they want to contribute to science, or believe that they will clinically benefit. Giving them financial remuneration is unacceptable," said Dr Pramesh.
The DCGI has amended it's January 2013 notification and has asked for comments from all stakeholders, industry persons and researchers to submit their recommendations by June 10.
"We are against clear lack of therapeutic benefits to the patients as being a ground for compensation. Another reservation is regarding submitting a report of an adverse drug effect and compensation within 21 days of an event. We need more time to assess the cases," said Dr Pramesh.
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