Biotech industry moots statutory body

Wants a scientific advisory board with eminent people as members

The Indian biotechnology industry has called for an autonomous statutory New Drug Authority body on the lines of Trai and IRDA. The industry has recommended that a scientific advisory board should be created with eminent people as members to guide the functioning of the authority.

The Indian sub-group on Cinical Research and Transfer of Biomaterials under Ficci8217;s Indo-US Joint Industry Working Group on Biotechnology has made wide-ranging recommendations for bringing about regulatory and fiscal changes to remove procedural and other impediments in the critical sector.

At a meeting of the group chaired by Dr M.K. Bhan, secretary, department of biotechnology, suggestions were made for adoption of special procedures for speedy transfer and early clearance for perishable biological material by creating a single window clearance by the Drugs Controller General of India DGCI. At present, clearances are required from the ministry of environment and Forests and the drugs controller and approvals take between 3-4 months.

The industry noted that the DBT should take up the issue of treating clinical research expenditure as R038;D expenditure with the Income Tax department. Further it was suggested that anomalies in duty structure between public and private sector be removed and clinical research be exempted from service tax.

Industry is also concerned at the 37 duty on instruments, which makes R038;D more expensive. India pays 37 plus 27 on the list price. It was observed that though most of the equipment for biotechnology and medical research does not attract any basic customs duty, additional customs duty, educational cess and cumulative additional cess 1622 are still applicable.

Further, relief in the form of blanket permission of upto Rs 1 crore for import of lab consumables to recognised R038;D set ups was also suggested based on the fact that cost of chemicals and reagents sold by US in India was higher by 200.