The Department of Pharmaceuticals (DoP) has directed the national drug price regulator National Pharmaceutical Pricing Authority (NPPA) to examine the documentary proof submitted by Cadila Healthcare Limited and re-fix the ceiling price of the formulation Co-Trimoxazole tablet.

Cadila Healthcare had earlier filed a review petition against price fixation of their formulation “Co-trimoxazole tablets” by the NPPA through its order No. S.O. 443(E), dated 14.02.2017 under Drugs (Prices Control) Order, 2013 (DPCO 2013).

In the review petition, the petitioner contended that the price fixed by NPPA for schedule formulation Co-Trimoxazole tablets vide ceiling price order no. S.O. 443(E) dated 14/02/2017 at sr. no. 15 of the order is not correct.  The ceiling prices fixed and notified by NPPA for Co-Trimoxazole (sulphamethoxazole 800mg + trimethoprim 160mg) Tablets vide notification no. 443(E) dated 14/02/2017 is without considering PTR of their company’s brand Oriprim DS tablet. Further company also submitted that PTR considered for Septran DS 800/160 MG tablet 10 is not correct.

There is gross error in the working sheet of Co-Trimoxazole (sulphamethoxazole 800mg + trimethoprim 160mg). Moreover with the incorrect price declared by NPPA, the product becomes non-viable. The formulation Co-Trimoxazole (sulphamethoxazole 800mg + trimethoprim 160mg) tablets was under price control under DPCO 1995 and continued to remain in DPCO 2013 which has resulted the reduction in the price by 26.5%, while input cost has gone up substantially, the petitioner further contended.

During examination, the DoP noted that the NPPA has fixed the ceiling price of Co-Trimoxazole tablet (sulphamethoxazole 800mg + trimethoprim 160mg) by taking the average of per unit price of two formulations of Glaxosmithkline Pharmaceuticals Ltd. The company claimed that three more formulations of similar strength, viz. Sepmax DS tablet 10 of Glaxosmithkline; Bactrim DS tablet 10 of Abbott Healthcare and Oriprim DS 800 MG tablet of Zydus Alidac, are also available in the market. In support of their claim, during the personal hearing, the company submitted documentary proof along with additional submissions, the copy of which is placed at pages 92-107/cors. The claim of the company made in the review application that the PTR considered for Septran DS 800/160 MG tablet of Glaxosmithdklin is not correct, has no relevance as the company could not provide any documentary proof in support of its claim. The company also raised various other issues, which are of administrative nature and has no relevance with the review of the petition.

The DoP further noted that since the company has submitted sufficient documentary proof along with its review application and also during the personal hearing, it is proposed that NPPA may be directed to examine the documents submitted by the company and re-fix the ceiling price of the formulation Co-Trimoxazole Tablet, after getting confirmation from Pharmatrac, on merit.

“NPPA is hereby directed to examine the documentary proof submitted by the company and re-fix the ceiling price of the formulation Co-Trimoxazole tablet, after verification, on merit,” the DoP ordered.