India has been an attractive destination for clinical trials because of its large population and varied demographics. Despite having tremendous potential, only 1–2% of global clinical trials are being conducted in India. To utilize its full potential with respect to the trained GCP professionals, trained investigators as well as infrastructure, […]
India has been an attractive destination for clinical trials because of its large population and varied demographics. Despite having tremendous potential, only 1–2% of global clinical trials are being conducted in India.
To utilize its full potential with respect to the trained GCP professionals, trained investigators as well as infrastructure, Indian Government has undertaken few positive initiatives, which has relaxed the norms and regulations of conducting Clinical Trial in India which we shall discuss below in this article. The initiatives taken by Indian Regulatory Agencies might make India a favourable destination for conducting good clinical trials and help in creating a favourable environment for the pharmaceutical sector to advance.
New Initiatives Taken by CDSCO:
Huge patient database and trained GCP professionals makes India an outreach.
Benefits of Conducting Clinical Trials in India
Global Clinical Trial Definition:
Global clinical trials are large scale trials conducted across populations from multiple countries to enable high quality, unbiased outcomes.
Documents Required To Be Submitted To Conduct A Global Clinical Trial
Some of the crucial steps in Conducting a Clinical Trial
– Investigator
– Sponsors
– Interventions
– Patient population
– Trial size and Target sample size
– Date of enrolment
– Documenting results
– Audio-visual recording
– Positive outcomes
– Unfavourable outcomes
– Adverse events
Challenges faced in India for conducting Clinical Trials
Impact of Challenges
Mission and Vision of New Initiatives
Summary of New Initiatives taken by CDSCO
Abbreviations
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