the world , India is conducting just 2,835 trials . Compared to the population size of India , this is miniscule , he said .
As per a very recent comment by Ms Suneela Thatte , President , Indian Society for Clinical Research ( ISCR ), clinical research plays huge role in helping millions of patients the world over get access to new and novel medical treatments and it is the time to thank those who have participated in clinical trials and helped in the discovery of life saving medicines and therapies . “ All stakeholders need to work together to rebuild confidence and trust amongst the global community in doing clinical research in India now that we have a more conducive regulatory environment in India for the conduct of clinical research ,” she stated .
Policymakers need to build confidence
The government can train people in e-filing and they also need to adhere to timelines . On the part of the industry , professionals must also gear up and start discussing with various government agencies . Associations need to play a more active role now . The mushrooming of a few small unethical CROs are bringing a bad name to the entire industry . A minimal qualification should be there for the establishment of CROs and a basic standard has to be set so that people do not come into this line only for business interests . The lack of enough inspectors in India is also one of the issues that needs to be looked into by the government . There is the need to provide international exposure to these inspectors .
Improve the image of clinical research in the country by working closely with health authorities , organising patient awareness programs , strengthening collaborations with the media and introducing clinical research as a subject in pharmacy and medical college . Enhance the quality of trials conducted in India by strengthening the regulatory framework ; increasing awareness among stakeholders including patients ; accrediting investigators , sites and ethics committees ; and increasing frequency of regulatory inspections .
In fact during 2015 , the health ministry proposed presubmission meetings in a bid to enable technical deliberations between stakeholders and the drug regulator before clinical trial applications are submitted . Now on a fresh note , reiterating the commitment of Central Drugs Standard Control Organisation towards the availability of drugs for major diseases , Dr G N Singh , Drug Controller General of India ( DCGI ) in his recent message mentioned , " CDSCO is committed in this journey to enable newer therapeutic options being made available to Indian patients at an earliest . I urge all clinical research stakeholders to reiterate their commitment to patient safety , ethics and quality and to work together to ensure we address our growing disease burden effectively and efficiently .”
The regulator said this in the message on the occasion of International Clinical Trials Day posted on CDSCO website on 20th May , 2016 . Dr Singh also lauded the patients who volunteer to join the clinical trials . " I would like to applaud the noble efforts of
INDIA ’ S POSITION GLOBALLY :
Country USA 92,787 Canada 15,268 Germany 14,302 UK 11,899 China 7,602 South Korea 7,109 Australia 5,135 Brazil 4,952 Japan 3,950 Russia 3,336 India 2,835 South Africa 2,175 Singapore 1,587
Clinical Trials
Source : Data from Pugatch Consilium
patients who participate in clinical trials and thank the clinical fraternity for the contribution in bringing new , safer and more effective drugs to market ," he stated .
It is a both way street . Industry has to ensure that it will follow the guidelines and identify the back sheep who due to their actions bring disrepute to it , the government too has to ensure that it deals firmly with the scaremongering . Awareness about the importance of clinical trials as a part of drug discovery process has to be made known to public through workshops and appropriate forums .
BIOVOICENEWS . COM 17