1. ‘India has more conducive regulations for clinical research’

‘India has more conducive regulations for clinical research’

India has more conducive regulatory environment for conduct of clinical research, according to Indian Society for Clinical Research (ISCR).

By: | New Delhi | Published: May 20, 2016 6:49 PM

India has more conducive regulatory environment for conduct of clinical research, according to Indian Society for Clinical Research (ISCR).

However, the regulatory challenges, misconceptions about clinical trials and lack of awareness amongst the general public are the most important factors holding back the progress of clinical research in India, it said.

“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,” ISCR President Suneela Thatte said in a statement here.

At the International Clinical Trials Day today, the clinical research fraternity in the country opines that regulatory challenges, misconceptions about clinical trials and lack of awareness amongst the general public are the most important factors holding back the progress of clinical research in India.

A recent survey conducted by pharmaceutical company Sanofi identified several critical requirements like improving 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.

ISCR believes that while the value of clinical research in India is being appreciated more, its full potential has yet to be realized. India has 17 per cent of the global population and 20 per cent of the global disease burden yet its share of all clinical studies being done in the world is less than 1.4 per cent.

Given that many of the regulatory challenges of the last two years have now been addressed through new amendments and orders, there is a need to rebuild the confidence of global and local stakeholders in order to strengthen clinical research in India.

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