Global CROs, intl research centres and bio pharma cos eager to include India for their human studies

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Global clinical research organisations, leading international research centres and the bio pharma companies abroad are keen to conduct human studies on the  Indian patient population. This is where, the union government will need to take speedy decisions on clearing the recommendations put forth by Prof. Ranjit Roy Choudhury Committee’s recommendations to kick start human studies in India.

The fact is that National Institute of Health in the US and the University of Oxford in the UK have not written off India for conduct of human studies.  These countries have only suspended clinical trials in India following the Supreme Court order in early 2013 but not stopped any trial here. Recently, countries like Ukraine and Russia have also evinced interests to include Indian patient data through  clinical trial studies in their global drug development programmes, Prof. Ranjit Roy Choudhury, chairman of expert committee on clinical trial told Pharmabiz.

“Therefore there is a huge genuine and visible interest for India because of the presence of medical expertise and the capability of India to conduct human studies in an ethical manner. Now the government will need to take a cue from this and take a speedy decision to bring in five changes into the clinical trials. These are  low hanging fruits vital to the industry. Now if the given changes are brought in covering accreditation of the three  entities clinical trial investigators, clinical trial sites and the ethics committees, training of investigators  and the compensation, then we could be back on the track.  What we are witnessing now is a slow paced process in the outcomes of the recommendations”,  he added.

‘There is need to adopt a faster decision making process because right now the issue is the challenge of slow paced procedural approvals. However, in my view, there is already light at the end of the tunnel because the government accepted the recommendations of my Committee. But my view is that if the government takes out the five crucial recommendations and make it an office order and not wait for it to be mandated as a law then clinical trials in India could see some traction”, noted Prof. Roy.

The government has accepted all 27 of the  30 recommendations. The three proposals which were not approved are the permission to market drugs developed abroad to be allowed for marketing without having a separate data on Indian patients. This was only in the case of drugs which were found to be absolutely safe without any  side effects. This is because the Committee saw it as a more progressive move and found it unnecessary to repeat a trial on those drugs which did not have any adverse reactions.  The second is the audio visual recording consent which is now seen to be feasible from a government perspective only if patients were  mentally challenged and for the paediatric population.  The third one was to permit phase I to III trials in India. But the pharma industry had stated that some tests needed to be done abroad, stated Prof. Choudhury.

Going by the positive response from global quarters on the need to conduct clinical trials in India, Prof. Choudhury stated that government will need to hasten its stand on this.

Source: PharmaBiz

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