CDSCO strengthens oversight of Clinical Trials

The number of clinical trials approved by the CDSCO had increased to 185 in 2019 in the wake of implementation of New Drugs and Clinical Trial Rules.

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Mumbai: In a bid to ensure compliance of good clinical practice guidelines for clinical studies in India, the Central Drugs Standard Control Organisation (CDSCO) has stepped up inspection of clinical trial sites of biological products as well as new drugs in the country.

A total of 115 clinical trial sites of biological products and 30 clinical trial sites of new drugs have been inspected by the central licensing authority over the last three years.

As many as 14 show cause notices have been issued during the last three years for observation reported in inspection report of new drug clinical trial sites, said sources in CDSCO.

The number of good clinical practice inspection (GCPI) of clinical trial sites of biological products by CDSCO officials was 16 in the year 2017.

In 2018 there were 53 GCP inspections of clinical study sites of biological products by the officials of central licensing authority.

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Also read: DCGI releases list of reference products for BE study

There were 47 GCP inspections of clinical trial sites of biological products till October 2019.

As per New Clinical Trial Rules, 2019, the work of every clinical trial site is overseen by an Ethics Committee for registered clinical trial, before initiation and throughout the duration of the conduct of such trial.

On the other hand, the number of clinical trial inspection of new drugs by CDSCO officials stood at 5 in 2017.

The number of inspection by officials of central licensing authority had further increased to 21 in the year 2018.

In 2019 there were just two inspections of new drug clinical trial sites by CDSCO officials.

The introduction of the New Drugs and Clinical Trial Rules, 2019, has brought clarity in regulatory approval process and monitoring for clinical trials, while ensuring that patient safety was not compromised.

Also read: Approval procedure of 2,131 FDCs: DCGI

It will help increase number of clinical trials conducted in India to find newer treatment options for the unmet medical needs of Indian patients, said Dr. Chirag Trivedi, president, Indian Society for Clinical Research (ISCR).

As of now India accounts for just one per cent of global clinical trials. In 2018 there were 30 clinical trials approved by the CDSCO.

The number of clinical trials approved by the CDSCO had increased to 185 in 2019 in the wake of implementation of New Drugs and Clinical Trial Rules. Of 185 clinical studies, 97 studies were part of global clinical trials, said Dr Trivedi.

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