India will soon assume the leadership status in clinical trials and garner the limelight as the hub of global human studies once the government accepts and implements the expert committee recommendations on clinical trials, said Prof. Ranjit Roy Chaudhury who headed the committee which recommended sweeping changes in clinical trial sector in the country.

Presently, the union government is examining all the 30 proposals of the Prof. Ranjit Roy Chaudhury Expert Committee which had submitted its report recently.

From accreditation of centres conducting human studies to compensation, audiovisual recording of the informed consent, joint monitoring by state drugs control departments are seen to ensure that India will now take a prime of place for clinical trials.

Only introduction of such transparency will add strength to the drug regulatory system, reduce bias in the decisions being made, and give a sense of satisfaction to all stakeholders that the clinical trials carried out in this country are fair and no exploitation of the volunteers and participants is possible. The Union and state governments along with research institutions should create a fund in order to encourage academic and clinical research, said Prof. Roy. “Even if clinical research was at present experiencing a serious blow, there were reasons for the same. The Supreme Court needed to ensure that the government did not turn a blind eye to the development in the area of human studies.”

“But now with our solid recommendations for an ethical and scientific human studies conducted in a transparent   manner would see India at the forefront of human studies. Following these recommendations, the clinical research would be strengthened,” he said.

Prof. Roy in his keynote address at the 8th Annual conference of DIA on 'The new clinical research environment in India: Implications and Opportunities' said that we have laid down the system on how well clinical trials could be conducted. Globally all these norms are being adhered to. Therefore all these recommendations would only fuel growth of the sector.

“We have highlighted that accreditation is base of any clinical trial and could only be carried out at centres which have been accredited for such purpose. The principal investigator of the trial should be an accredited clinical investigator. The ethics committee of the institute must also have been accredited. Only those trials conducted at centres meeting these stipulations will be accepted by the Drugs Controller General of India (DCGI).

A Central Accreditation Council should be set up to oversee the accreditation of institutes, clinical investigators and institutional ethics committees. Selection of assessors for accreditation to review new drug applications and other purposes will be made by a blind randomized procedure from a Roster of Experts. This Roster will be prepared after a nationwide search of appropriate experts and approval by the Technical Review Committee. The selection will have built in safeguards for gender sensitivity and geographical representation. A roster will be maintained of accredited institutes and medical centres approved to carry out  clinical trials. Pharmaceutical houses will be permitted to identify centres from this roster for  particular clinical trial to be carried out.

The 12 drug advisory committees which are functioning at present will be replaced by one broad expertise-based Technical Review Committee to ensure speedy clearance of applications without compromising on quality of data and rules and regulations. The Committee would be assisted as required by appropriate subject experts selected from the Roster of Experts.

An informed consent from each participant is a mandatory prerequisite. Audiovisual recording of the informed consent process should be undertaken and the documentation preserved, adhering to the principles of confidentiality. All these would only see India retain its leadership status, said Prof. Roy, who is national professor of Pharmacology and Adviser to Department of Health, Government of National Capital Territory of Delhi and chairman Task Force for Research, Apollo Hospitals.