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DoP directs NPPA to re-fix ceiling prices of clomiphene 100mg and 50mg tablets
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Ramesh Shankar, Mumbai
September 19 , 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 relevant documents/ information furnished by the petitioner
company, Abbott India Limited, and after verification, to re-fix the
ceiling prices of clomiphene 100mg tablet and clomiphene 50mg tablet, on
merit.
Abbott India had earlier filed a review petition with
the DoP against price fixation of their formulations “Clomiphene 100mg
and clomiphene 50mg tablets” vide NPPA order No. S.O. 443(E), dated
14.2.2017 under DPCO 2013.
In respect of clomiphene 100mg, the
petitioner contended that the draft working sheet for ceiling price
calculation of clomiphene 100mg (vide 8(35)/2016/DP/NPPA/Div II dated
17.11.2016) was bearing anomaly in calculation. NPPA has considered PTR
as Rs. 104.64 for Clome 100mg tablet 10’s of Abbott India, whereas the correct PTR of Aug ’ 15 is Rs. 107.56. (PTR per tablet is Rs.
10.76). It further contended that the NPPA has erroneously
considered the same PTR for both Fertomid 100mg Tablets 10’s and
Fertomid 100mg Tablets 5’s of Cipla Limited. As per IMS data there is
only Fertomid 100mg tablets 5’s pack.
In respect of clomiphene
50mg, the petitioner contended that the draft working sheet for ceiling
price calculation of clomiphene 50mg (vide 8(35)/2016/DP/NPPA/Div II
dated 17.11.2016) was bearing anomaly in calculation. NPPA has
considered PTR as Rs. 3.41 per tab for
Clome 50mg tablet 10’s of Abbott India, where as they are not
manufacturing and marketing this pack. They have only one pack that is
Clome 50mg tablets 5’s. They requested this department to advise NPPA
not to consider the Clome 50mg tablet 10’s for the purpose of
calculation of ceiling price. The petitioner further contended that the
NPPA has erroneously considered the same PTR for both Ovafar 50mg
Tablets 10’s and Ovafar 50mg Tablets 5’s of Organon (India) Ltd. As per
IMS data there is only Ovafar 50mg tablets 5’s pack.
During
examination, the reviewing authority DoP noted that the NPPA has taken
into account certain formulations having MAT value of less than 1%. NPPA
may be directed to consider only those medicines/formulations having
MAT value of more than 1% market share, as DPCO does not recognize a
company for average PTR but only medicines / formulations.
“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 clomiphene 100mg tablet and clomiphene 50mg
tablet, on merit.”
“NPPA is also directed to re-fix the ceiling
prices of subject formulations by considering only those medicines/
formulations having MAT value of more than 1% market share as DPCO does
not recognize a company for average PTR but only
medicines/formulations,” the DoP ordered after examination of the
matter.
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