2018 (12) TMI 813

X X   X X   Extracts   X X   X X

Full Text of the Document

X X   X X   Extracts   X X   X X

....ch was disallowed by A.O. on the reason that the same was not certified by Prescribed Authority (DSIR) in Form 3CL. 2. Revenue has raised the followed grounds which are common for both the years under consideration:- "1. The CIT(A) erred in allowing the weighted deduction u/s 35(2AB) of the IT Act, 1961 in respect of the expenditure incurred in connection with the Bio Analytical and Bio Equivalence studies which is an expenditure incurred outside the "in-house" R & D Expenditure relying on the decision of the Hon'ble Gujarat High Court in the case of Cadila Healthcare Ltd. 2. The CIT(A) ought to have observed that the issue has not reached finality by way of Apex court has remitted the issue back to Gujarat High Court f....

X X   X X   Extracts   X X   X X

Full Text of the Document

X X   X X   Extracts   X X   X X

....sallowed when the expenditure incurred by the company is wholly and ex clusively for and on its Approved Facility. It is expressly provided in the Explanation to clause (1) of section 35(2AB) I that the expenditure on clinical drug tails in relation to drugs & pharmaceuticals is part of scientific research expenditure eligibl e for weighted deduction. For conducting Bio Analytical and Bio Equivalence Studies it requires hospital type facility and hence normally these studies will be conducted in outside facility duly approved for this purpose. In view of the above, it was submitted that the expenditure on Bio Analytical and Bio Equivalence Studies which forms part of clinical drug trials and which is must for product / process research and ....

X X   X X   Extracts   X X   X X

Full Text of the Document

X X   X X   Extracts   X X   X X

....rival submissions and perused the material on record. We find that similar issue came up for consideration before the coordinate bench of this Tribunal in assessee's own case for AYs 2011 -12 and 2012- 13 (supra), wherein the coordinate bench has held as under: "9. We have considered the rival contentions and perused the case law placed on record. In the decision of Concept Pharmaceuticals Ltd (supra) the Coordinate Bench did not allow the expenditure spent outside the R & D unit but the Bench has not considered the explanation introduced with reference to 'Clinical Trials'. By very nature, the Clinical Trials cannot alone be done within research facility as they require cooperation from the Medical Doctors, Hospitals, Volunteers a....