NEW DELHI, APRIL 30:
The
final rules and regulations on clinical trials in India are likely to
be in place by the year-end, a senior government official said on
Thursday.
“The
regulatory pathway is in place, a compensation system is in place, and
with the call for ‘Make in India’, we should aspire to be a global
clinical hub,” said GN Singh, Drug Controller General of India. He was
addressing a workshop on clinical trials and issues organised by Fortis
Health Care and JK Risk Managers and Insurance Brokers here.
AK Pradhan, Deputy Drug Controller General, said
the roadmap for conducting clinical trials was approved last month by
the Technical Advisory Board and is now under the Health Ministry’s
consideration.
By
mid-June, online processing and monitoring of applications for clinical
trials should be operational, he said, adding that the mandatory
accreditation process is also due to start in July.
As
per the draft guidelines, applicants can also pay a fee to the
government for pre-submission meetings with the regulator and expert
panel members, he said.
Pradhan
said after obtaining comments from all stakeholders, draft guidelines
for audio-visual (AV) recordings of consent from patients who opt for
clinical trials are also nearing finalisation after being examined by a
committee of stakeholders.
“India
offers a very lucrative environment for clinical trials…The country
also offers a significant cost advantage… 40-60 per cent lower than in
developed countries and 10-20 per cent lower than in emerging
economies,” said Upendra Kaul, Head, Department of Academics and
Research, Fortis Health Care.
The
draft guidelines put out by the DGCI in March this year make any
violation punishable with debarment, putting investigators, ethics
committee members and even hospitals on notice.
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