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The Drug Controller General of India (DGCI) will be introducing a new software to streamline the process of clinical trials soon.
“We have already set up a clinical trials registry. The software to be introduced would immediately identify the adverse impact during the trial of any particular drug,” Dr Surinder Singh, DGCI, said while addressing the delegates at a national seminar on ‘Regulatory challenges — global pharmaceutical market' here on Saturday.
Observing that there was a ‘huge' potential in clinical trials segment, he said the hype being created in media that some ‘terrible' things were happening in trials was not correct.
“When we talk, we need facts and figures. Out of one lakh clinical trials being conducted globally every year, 52,000 are being conducted in the US while only 1500 are undertaken in India,” he said.
The DGCI was willing to discuss the issue of cost escalation in the proposed implementation of 2D Barcode on pharma exports from India, he said. “The Ministry of Commence is getting letters from our embassies abroad about spurious drugs which are tarnishing our image. Even if 5 to 10 per cent of manufacturers are doing this, this is a big threat,” he said.
The provision of barcode on label of a tablet would not cost more than 30 paisa, he added.
Inspection
As part of overseas inspection initiative, a team would leave for China soon to conduct inspection soon, he said. The DGCI would also inspect manufacturing plants of global majors who are exporting to India in various other countries including Italy and the US.
Initially, it would only certify the units. “But in next two/three years, we are thinking of making this certification mandatory for exporting drugs into India once we have wherewithal to conduct such inspections overseas on a regular basis,” Dr Singh said.
Plans are afoot to constitute a separate team of about 50 drug inspectors for undertaking overseas inspections. “We are also ramping up our manpower from 73 drug inspectors now to over 1,000 in about year. This will help us to concentrate on overseas inspections,” he said.
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