TRAI-like status sought for New Drug Authority
Indian biotechnology industry has mooted the idea of an independent drug regulator on lines of TRAI, IRDA for removing procedural and other impediments in the critical sector.india Updated: Aug 20, 2006 15:58 IST
Indian biotechnology industry has mooted the idea of an independent drug regulator on the lines of TRAI and IRDA for removing procedural and other impediments in the critical sector.
FICCI said on Sunday that industry representatives in a meeting with an Indian sub-group under the Indo-US joint industry working group on biotechnology has suggested that new proposed New Drug Authority should be an independent statutory body.
The representatives said a scientific advisory board should be created for the purpose. NDA is being considered by the Ministry of Health and Family Welfare on the lines of FDA of the US.
The industry also suggested at the meeting chaired by Department of Biotechnology MK Bhan that the transition from old to the new drug administration should be smooth in order to not adversely impact the industry.
A scientific advisory board should be created for the purpose with persons of eminence who can guide its functioning, the chamber said.
Industry called for adoption of special procedures for speedy transfer and early clearance for perishable biological material, which could be achieved through a single window clearance by the Drugs Controller General of India (DGCI), it said.