The Department of Pharmaceuticals (DoP) has rejected the Serum Institute of India’s review petition of for ceiling price for single dosage and multi-dose DPT vaccine on the plea that the Committee of Experts has recommended not to fix separate ceiling price for DPT vaccine based on pack size.
Prior, by the NPPA the Serum Institute had documented a review application with the reviewing authority, DoP, against price fixation of their formulation “DPT Vaccine 0.5ml” through its order No. S.O. 1688(E), dated 24.05.2017 under DPCO 2013. In the review petition, the ceiling price fixation and the computation aren’t according to the provision of DPCO, 2013 for a few reasons contended by the petitioner.
While arriving at the ceiling price of DPT 0.5ml, the PTR and MAT details of all type of formulations i.e. single dosage and multi-dose DPT vaccine formulation have been taken together.
The price of single dosage and multi-dose vaccine don’t move in a linear progression as implied to have taken in price working. The petitioner additionally contended that similarly in the computation sheet PTR and MAT details were taken from one manufacturer Biological E Ltd seems to be incorrect and they are never again supplying DPT 0.5ml vaccines.
In this way, there is a need to recalculate the ceiling price working under Para 18 (ii) and (iii) of DPCO 2013- revision of ceiling price based on moving annual turnover (MAT).
During the examination of the case, the DoP noticed that ongoing the submission made by NPPA, it is observed that NPPA had raised the issue up in the 4th (continued) meeting of Committee of Experts under para 11(3&4) of DPCO, 2013 and the Committee suggested that separate ceiling price fixation for packs may not be considered.
As the Expert Committee’s suggestion has just been obtained and it has been recommended by the Committee not to fix separate ceiling price based on pack size, the demand of company for separate ceiling price based on pack size can’t be agreed to. In perspective of this, the review of the petitioner organization might be rejected.
The DoP order said, “The Committee of Experts has recommended not fixing separate ceiling price of DPT Vaccine based on pack size. In this way, the demand of Petitioner Company for separate ceiling price of Single dose and Multi-dosage DPT Vaccine can’t be agreed to, and the review application stands rejected”.