The Department of Pharmaceuticals (DoP) has directed the national drug price regulator NPPA to re-fix the ceiling prices of snake venom antiserum – soluble/liquid polyvalent injection after examining the relevant documents/ information furnished by Biological E. Limited who had filed a review application against price fixation of their formulation snake venom antiserum – soluble/liquid polyvalent injection by the NPPA.

In the review application filed by Biological E. Limited against price fixation by NPPA through its order No. S.O. 1334(E), dated 27.04.2017, the petitioner contended that it manufactures snake anti venom serum (ASVS) - soluble / liquid polyvalent format (pack size is 10 ml). On the basis of the directions passed in a review order by the DoP vide letter no. 31015/45/2014 P.I. in respect of SO 2251(E) dated 22-7-2013, NPPA had fixed the ceiling prices separately for specific anti-snake venom - injection polyvalent solution and specific anti-snake venom lyophilized polyvalent serum.

The petitioner submitted that NPPA has displayed draft computation of ceiling price calculation sheet proposed to revise the ceiling price fixed on 25th March 2015. On going through the draft calculation sheet, company noticed that there is an error apparent on the face of the record. NPPA has taken Rs.265.90 as PTR of their product - anti-snake venom injection of 10 ml., which is grossly erroneous.

It further submitted that their objection to NPPA informing the mistake that has creeped in the draft calculation sheet. They also enclosed copy of invoice of August 2015 and also summary of August 2015 invoices. The correct PTR of their product as on August 2015 was Rs.404.08. Hence, the ceiling price determined vide reference cited above at Rs.351.44 is grossly erroneous and liable to be set aside.

In reply to the contention of the company, the NPPA commented that the ceiling price Rs.351.44/10 ml pack and the same was revised to Rs.337.05/10 ml pack vide S.O. 2058(E) dated 30.06.2017 as per Para 4, 6, 10, 11, 14, 16, 17, & 18 of DPCO, 2013. The company has stated that correct methodology was not followed in arriving at the ceiling price of anti-Snake venom. The points raised by the company are not relevant. Price fixation has been done strictly in accordance with the provisions of DPCO, 2013.

During the examination of the case, the DoP noted that the petitioner company, in its review petition, stated that they had represented against the draft working sheet. However, NPPA did not consider the representation of the company as the data/supporting documents submitted along with representation was in line with the requirement. During the personal hearing, the petitioner company submitted documentary proof in support of their claim that the correct of PTR of their formulation snake antivenom injection 10 ml is Rs.404.08 instead of Rs.265.90 considered by NPPA. In view of the above, the hearing authority is of the opinion that NPPA may be directed to examine the relevant documents/information furnished by the petitioner company, and after verification, to re-fix the ceiling price of snake venom antiserum – soluble/liquid polyvalent 10 ml, on merit.

“NPPA is hereby directed to examine the relevant documents/information furnished by the petitioner company, and after verification, to re-fix the ceiling prices of snake venom antiserum – soluble/liquid polyvalent inj., on merit,” the DoP ordered.