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Indian registered clinical trials soar

By Nick Taylor , 03-Sep-2009

Clinical trials registered in India have soared in the past 12 months, as the nation has shifted its policy on recording full study details from voluntary to advisory and in June to mandatory.

By changing the policy Indian regulators hoped to increase transparency and bring the country’s procedures inline with other agencies. At the start of 2009 the drugs controller general of India (DCGI) advised that companies should register clinical trials in India.

This move had a small but noticeable effect on clinical trial registrations, which are detailed on the graph below. However, since news that registration would become mandatory surfaced in April the number of clinical trials posted has increased significantly.

In August 76 clinical trials were registered, a new high for India but still considerably fewer than in the US, where clinicaltrials.gov records 520 studies being added over the same period.

However, India is predicted to capture a larger share of the clinical trial market in coming years and mandatory registration forms part of this effort.

By registering all human trials it is hoped that the nation will improve its reputation as a place to conduct clinical trials, encouraging wary companies to operate in the country.

Furthermore, India is trying to avoid a repeat of the problems that led to 49 infants dying during clinical trials. This caused a political backlash against foreign companies conducting clinical trials in India.

The data was collected on 31st August from the Clinical Trial Registry – India , which contains information about a study’s purpose, sponsors and principal investigator. At the time of collection 454 trials were registered on the website.

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