Assocham seeks to quicken clinical trial approval processes

Assocham seeks to quicken clinical trial approval processes
PTI
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First Published: Tue, Sep 29 2009. 05 58 PM IST
Updated: Tue, Sep 29 2009. 05 58 PM IST
New Delhi: Industry body Assocham on Tuesday said it has written to the Prime Minister Manmohan Singh seeking a direction to the ministry of chemicals and fertilisers in redesigning clinical trial approval processes.
“In a letter written to the Prime Minister... we had sought his intervention to direct ministry of chemicals and fertilisers to reshape its clinical trial approval processes,” the chamber said in a release.
The early approval of clinical trials are sought so that domestic firms can roll out their products without any delay, it added.
In India, it takes eight months in getting nod for conducting clinical trials by pharma companies which puts the Indian firms at disadvantageous position against their counterparts in developed countries, it said.
“There is a need to accord approvals for conducting clinical trials within a stipulated time frame of 30 days to avoid competitors of domestic pharmaceutical industry to take advantage as it is difficult to keep pharmaceutical innovations confidential,” Assocham said.
Further, it said there is a need to increase the number of drug inspectors to 3,000 from the present 1,000 to maintain drugs quality.
“The current number of drug inspectors of about 1,000 is totally inadequate to establish quality of drugs, manufactured by over 25,0000 pharma firms. So, there is a need to increase the inspectors from 1,000 to 3,000,” Assocham president Sajjan Jindal said.
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First Published: Tue, Sep 29 2009. 05 58 PM IST