Final regulations on clinical trials likely by year-end

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.