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May 20, 2017 05:55 PM IST | Source:

Govt to unveil new clinical trial policy soon; single clearance, transparency key features

The new policy expected to be unveiled in a month includes single clearance for clinical trials and is more transparent.

To attract more clinical research into the country, the government is set to roll out a new clinical trial policy that promises faster approvals without compromising on patient safety.

The new policy expected to be unveiled in a month includes single clearance for clinical trials and is more transparent.

“The government, in consultation with stakeholders, has devised new rules that will require more information of the patients enrolling themselves for clinical trials,” GN Singh, the Drug Controller General of India (DCGI) at the day-long conference organised by the ‘USA-India Chamber of Commerce’.

Addressing the annual US-India BioPharma and Healthcare Summit in Boston, Singh said the government is working with stakeholders to devise new rules for clinical trials that are expected to bring new projects to India.

“India has 17 percent of world’s population, 20 percent of disease burden yet less than 1.4 percent of global clinical trials happens in India,” said Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) on Saturday.

CDSCO encourages more clinical research in India for development of safer and more effective medicines for our growing disease burden.

Drug makers often complain about slow approval process in India.

A top executive of an Indian drug maker which is into development of novel antibiotics said he would prefer to do clinical trials outside India, due to delay in approvals.

"We have been awaiting approval for nine months to start phase-3 clinical trial of one of our drug," the executive said. The executive said his company has submitted data of previous clinical trial done in US.

"We expect time bound approval, we still work in a stone age," the executive added referring to Indian regulatory system.

Over the last few years, clinical trials in India have slowed down amid court cases and rising protests from health activists on issues related to informed consent and compensation norms.

Several clinical research organisations (CROs) have to shut down and the few remaining have to drastically cut back their operations as innovator companies and research institutes reduced giving clinical research contracts in India.

With inputs from PTI
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