DoP asks NPPA to re-fix ceiling price of Co-Trimoxazole tablet after examining documentary proof submitted by Cadila Healthcare
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Ramesh Shankar, Mumbai
September 22 , 2017
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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.
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