Drug regulator keen on USFDA tie-up for trials, medical-devices

Posted AtFinancialexpress.com

New Delhi, Aug 8 National health watchdog Drug Controller General of India is seeking co-operation from US Food and Drug Administrator for effective regulation, particularly for medical devices and clinical trials in the country.

“We have identified five areas for co-operation with the US FDA, which includes new drugs, medical devices, clinical trials, pharmacology and IT and IT-enable services (in healthcare),” Drug Controller General of India (DCGI) Surinder Singh said.

He said DCGI sought help of the USFDA particularly for medical devices and clinical trials, as there was already a system in place for the rest of the areas. As per the discussions held between DCGI and its counterpart, experts from the USFDA would hold workshops and training sessions in the country for Indian inspectors to help them in better monitoring of the healthcare industry.

“Experts from US authorities have agreed to come here and would train our people in the field of inspecting and auditing medical devices and clinical trial sector,” he added.

Medical devices, according to the definition of Indian government are considered as Drug and are put under the same regulations as for the medicines.

The government with the help from USFDA is working on bringing guidelines for the sector according to the global standards, which according to the experts in the industry would be helpful in boosting exports also.

USFDA would also help DCGI in better monitoring of clinical trials in the country as till now government's role was limited only in providing licenses and scrutinising data for the clinical trials in the country.

August 14, 2008