Global clinical research organizations, leading international research centers and the bio pharma abroad are keen to conduct the human studies on the Indian patient population. This is where, the Union government will need to take speedy decisions on the recommendations put forth by Prof Ranjit Roy Choudhury Committee to kickstart human studies in India.

Prof Choudhury, Chairman of the Expert Committee constituted by the Ministry of Health and Family Welfare, government of India to suggest standard operating procedures (SOPs) for approval of new drugs and clinical trials and banning of drugs is also the National Professor of Pharmacology (NAMS), Adviser-Department of Health and Family Welfare, and Chairman-Task Force for Research, Apollo Hospitals Educational and Research Foundation (AHERF). In an interaction with Nandita Vijay, Prof. Choudhury discusses at length about the highlights of his report and stated that there is already light at the end of the tunnel. Excerpts:

Could you pick out the most important and indispensable regulations in your clinical trials recommendations?
The important aspects of the recommendations cover accreditation of the clinical centres where human studies will be conducted, clinical trial investigators, training of personnel and compensation to the trial volunteers during an adverse drug reaction. Specifically training should focus on how to determine the health impact which affects compensation. In addition, the components calling to three entities: clinical trial investigators, clinical trial sites and the ethics committees are seen to be key aspects of my recommendation.

Could you tell us the current status of these recommendations which have been presented?
The recommendations are being looked into. The Apex Committee established by the government of India to regulate and supervise the clinical trials, is going to be the final authority. All that I can say is that Apex Committee and the Technical Committee has the right not to accept my recommendations because they are now identified as the two high-level panels to supervise the clinical trials sector, The Supreme Court is exercising its mind and the National Drug Advisory Committee (NDAC) has applied its mind.

You had called for the setting up of a National Accreditation Council. In your opinion who should be the members of the same?
Now it is the technical committee which is assessing the centres where the clinical trials could be carried out. National Accreditation Council will look to audit and qualify centres to conduct human studies along with the Quality Council of India. It will also select the ethics committee members and chief investigators.. The activities have already commenced but it will take some time to be ready. There is no doubt that the general public will be assured that the clinical trials are taking place properly.

What has been the government view point on the acceptance of the recommendation and could you also provide the feedback from the CROs?
Government has accepted all 27 of the 30 recommendations. But has now agreed to the three recommendations. One recommendation is related to drugs sourced from abroad where if its data indicated no side effects, then it could be straight away marketed in India because my committee viewed it as a more progressive move. The second is the audio visual recording consent which the government felt was not right in the case of mentally challenged population. The third was the permission for phase I to IV studies to be carried out in India to speed up drug development. In this case, we are also convinced that some tests need to be done abroad.

Could you tell me what needs to be done to include the subject of bio–medical ethics in the MBBS curriculum? How has the Medical Council of India (MCI) accepted this proposal and what is the time line needed usually to include a subject in the MBBS syllabus?
All medical colleges need to include bio-medical ethics. Although it is not a rule, MCI has too recommends it. The World Health Organisation (WHO) released a booklet titled ‘Bio-Ethics’ for under graduate medical students. Indian medical colleges need to start it.

Has the industry begun to adopt the GCP (good clinical Practices) training following your recommendations making it mandatory for all investigators to take on such programmes?
Yes there is a positive response on GCP. Clinical research organisations (CROs) and pharma industry have accepted the proposal expect for the details on the compensation.

You have called to create a national fund for compensation in case of injuries during trials for academic institutions. Does this mean that the health ministry will need to allocate an amount from its budget share or do you think the country needs to depend on international/external assistance?
The Planning Commission has agreed to allocate funds to compensate during a clinical trial. Therefore there is no need to look for external funding which usually is not the case. There are several human studies being undertaken at the academic institutes including PGI Chandigarh and the All India Institute of Medical Sciences (AIIMS) where the Institute does not provide the compensation but depends on a government source.

How has the global pharma industry reacted to the Supreme Court order and have the international pharma companies opted to prefer other countries over India for human studies?
It is a fact that many global pharma companies have shifted their trials from India to other locations but not stopped the human studies completely from India. The National Institute of Health, US and the Oxford University, UK Government are of the view that India now needs to move faster but the whole process is seen to be slow in terms of procedural approvals.

When would there be light at the end of the tunnel for CROs? Would India retain its past glory as the hub of affordable and quality human study data?
There is already light at the end of the tunnel. My feeling is that if we take out five of the crucial recommendations and make it an office order and not a law then clinical trials in India could see some traction. From the Ukraine and Russia, there are already requests and interests to include Indian patient data for clinical trial studies. Therefore there is a huge interest for India because of the presence of medical expertise and therefore there is a need to conduct the human studies ethically. This is a slow business but low hanging fruits are vital to industry if the 5 changes are brought in. We can position ourselves as a leading hub for human studies.

What are the challenges you see in the clinical trial sector today?
There is a lack of faith which is obvious but this is bound to change. Since my report has been accepted in 14 days, clinical trial companies now need to initiate a dialogue with the government. But I do not see any pressure from them to press the government to bring back the fervour of conducting human studies. It is high time the CROs communicate with the government to accept the Ranjit Roy Chaudhury report and speedily implement the norms. What we are seeing now is that the CROs are not strong and united on this move.