The timeframe required for clearing the application to send biological samples for clinical trials abroad will come down by two to four weeks at least, with the Commerce Ministry issuing notification to allow the export of the specimen without clearance from the DGFT.

"The no objection certificate from the CDSCO will be enough and there is no requirement for getting additional approval from the DGFT as existed earlier, as per the notification from the Commerce Ministry. This will reduce the additional time limit required for export of samples for trials abroad," DCGI Dr Surinder Singh has disclosed to the industry players at a recent round table.

Whole human blood plasma and all products derived from human blood except gamma globulin and human serum albumin manufactured from human placenta and human placental blood, raw placenta; placental blood plasma can now be sent without DGFT clearance.

He said the government had taken away the service tax on new drug testing last year to encourage the activities in contract research sector which threw up huge opportunity for the Indian companies, especially in the wake of global recession forcing the multinationals to cut down the expenses.

However, referring to the request by the industry to allow analytical lab studies of samples in India as part of trials for drugs, being developed and to be used for patients abroad, the DCGI said the present laws did not permit the same. Only the samples with regard to the trials of drugs to be used in India could be allowed here at present.

"We recently got an application of the kind and it was the first of the sort. We have referred it to the ICMR for advice. There are a number of policy bodies involved and should be taken on board before allowing such an application. I know that there is huge potential for the country in this regard, and we will look into it," he said at the roundtable conference on 'destination India - contract research in pharma and healthcare'. The event was organised jointly by Pharmexcil and the Association of Indian Contract Research Organisations (ACRO).