Clinical trial inspections to begin in India

CDSCO says that inspection of clinical trials in routine course across India will begin soon.

Updated: Nov 27, 2010, 19:56 PM IST

Ahmedabad: Apex drug regulator, Central Drugs Standard Control Organisation (CDSCO) today indicated that inspection of clinical trials in routine course across
the nation will begin in the next few days.

"Within just another couple of days clinical trials inspections in routine course will start in India. We have already chalked out a programme for this," Drug Controller General of India (DCGI) Dr Surinder Singh said.

According to Singh, there are 25 people who have been trained in clinical trial inspections by US Food and Drug Administration (USFDA).

"Inspections will be carried out by USFDA trained people, who know their job well. This will assure us of the quality of data generated and also about the volunteers safety," Singh said.

The registry of clinical trials conducted in India was made mandatory in 2009 by the apex drug regulator, thereby all the trials in the country are being listed.

The drug regulator will come out with a software in January next year, which is likely to put all the clinical trials related information in the public domain by March next year.

"The software will list information like how many trials are being conducted, how many deaths were reported during trials, what are the areas in which trials are being conducted, in the public domain by March next year," Singh said.

The move is expected to send a strong signal across the world that clinical trials in India are well regulated. At the same time it will assure civil society that interest of volunteers participating in such trials is well protected.

"The quality of data generated from the system will be such that it can be globally accepted," Singh said.

After clinical trials, the registration of Contract Research Organisations (CROs) will also become mandatory in the country, he said.

"The registration of CRO`s will become mandatory, after the gazette notification is issued. It is expected to be out in next 45 days or so," Singh said.

The move is expected to send a strong signal across the world that clinical trials in India are well regulated. At the same time it will assure civil society that interest of the volunteers participating in such trials is well protected.

"The quality of data generated from the system will be such that it can be globally accepted," Singh said.

After clinical trials, the registration of Contract Research Organisations (CROs) will also become mandatory in the country, he said.

"The registration of CRO`s will become mandatory, after the gazette notification is issued. It is expected to be out in next 45 days or so," Singh said.

PTI