The third meeting of Indian sub-group under the Indo-US Joint Industry-Working Group on Biotechnology has suggested that the Government should facilitate single window clearance for import of biological materials, SCOMET items, fast approval of Clinical Trial protocol, etc.

The meeting noted that for importing the live biological materials, clearance is required from the Ministry of Environment and Forests and DCGI. It takes 3-4 months for the clearances. It is important that special procedures are adopted for the transfer and early clearance for perishable biological material. The meeting suggested that DCGI should handle all the clearances as a single window.

Similarly for export of Special Chemicals, Organisms, Materials, Equipment and Technologies (SCOMET) items, industry has to apply to DGFT, which further takes clearances from at least three other ministries. It takes almost 6 months time to get the clearance. Some times industry has to repeat the process as they are not aware about the cross discussions. Suggestions were made that process may be streamlined and a single window clearance mechanism may be considered by the Department of Biotechnology.

The meeting also noted that the amended Schedule Y (D&C Act) has a clause that along with the approval of Clinical Trial protocol, if the applicant identifies any central laboratory outside India, the clinical trial samples can be sent to that laboratory for testing. In case of CROs, they apply to DGFT for permission to send clinical trials samples for which NOC is given by DCG (I). The process takes long time. This process should be simplified where DCG (I) is given the authority for single window clearance for Clinical Trial samples, the meeting suggested.

The meeting also pointed out that the cost of chemicals and reagents sold by the US companies in India is much higher (up to 200 per cent) than in the US. Suggestions were made that Government may consider to provide some relief to Indian companies by giving a blanket permission, up to Rs 1 crore, for import of lab consumables to recognized R&D set ups. DBT will also see what can be done on the issue of high prices.

Regarding export of the samples for pharmaco-genomics and permission from ICMR, it was suggested that only one regulatory authority should give clearance or opinion of experts may be requested. SOPs may be developed. The issue may be discussed with Health Ministry by the Department of Biotechnology. It was pointed, ethical guidelines being developed by the ICMR, which are independent of the Schedule Y, should be examined closely by the industry before the Bill is passed. Since it would be a new regulatory system, before its implementation, more feedback is required from the industry, sources said.

In order to facilitate the interaction, FICCI organised the third meeting of Indian sub-group under the Indo-US Joint Industry-Working Group on Biotechnology on July 17 at Federation House under the chairmanship of Dr MK Bhan, secretary, Department of Biotechnology. Ashwini Kumar, drugs controller general of India and other officials from the Customs and Excise participated in the meeting.