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DoP rejects review application filed by FDC against price fixation of “Metformin (1000 mg), flunarizine, ramipril etc”
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Ramesh Shankar, Mumbai
February 10 , 2017
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The Department of Pharmaceuticals (DoP) has rejected the review
application filed by FDC Ltd against price fixation of “Metformin (1000
mg), flunarizine, ramipril etc.”
The NPPA had earlier fixed the
ceiling prices of “Metformin (1000 mg), flunarizine, ramipril etc” vide
its order No. S.O. 1253(E) dated 29.03.2016 and SO 1405(E) dated
12.4.2016 under Drugs (Prices Control) Order, 2013 (DPCO 2013).
Aggrieved by the NPPA notification, FDC Ltd filed a review application
against the price fixation.
In the review application, the
petitioner contended that separate notifications should be issued for
existing scheduled medicines & others for which prices are notified
for the first time. In para 4 of DPCO, 2013, there is no provision to
add or subtract ceiling price due to increase or decrease in WPI index.
As mostly ceiling prices have been fixed for the first time, WPI index
linked reduction is not applicable. In Notification No. 1253, certain
existing scheduled medicines have been included such as atorvastatin 10
mg, metoprolol 25 mg and metoprolol 50 mg. For such medicines, price
reduction linked to WPI index is proper. However, in rest of cases where
ceiling price is notified for the first time under para 4, reducing
ceiling price linked to WPI index is uncalled for and is in
contravention of DPCO provisions (particularly para 4 and para 16).
It
further contended that majority of 173 medicines (103+70) covered under
Notifications 1253(E) and 1405(E) dated 29/03/2016 and 12/04/2016
respectively are medicines which were hitherto non-scheduled and by
virtue of Notification no. S.O. 701 (E) dated 10/03/2016 (NLEM 2015)
have become DPCO Schedule I drugs. In all these cases, WPI linked price
reduction cannot be made.
In reply, NPPA commented that DPCO,
2013 came into existence w.e.f. 15/05/2013 & NPPA has fixed that
ceiling price for Betaxolol hydrochloride drops 0.5% vide S.O No.
1677(E) dated 14/06/2013. The benefit of WPI was admissible after the
expiry of one year. As regards points No.5 to 11 of the review
application dated 19.4.2016 of the company, NPPA submitted that Para 4,
10, 11, 14, 16, 17 & 18 of DPCO, 2013 to be referred. DPCO, 2013 has
been issued under Section 3 of Essential Commodities Act, 1955. NPPA is
mandated to fix fair, reasonable and affordable prices for all
scheduled medicines under DPCO, 2013. Therefore, company’s requests
cannot be considered, as they do not seem to have merit.
During
examination, the reviewing authority DoP stated that the grievance of
the company is examined under the provisions of DPCO, 2013, and it is
seen that para 13(3) provides that in case of decline in wholesale price
index, a corresponding reduction in the prices shall be made as per the
provisions of sub-paragraph (4) of paragraph 16. Since the subject
formulations of the petitioner company became scheduled formulation by
virtue of Notification No.SO 701(E), dated 10.3.2016 (NLEM 2015), the
NPPA has rightly applied the WPI impact in respect of products of FDC to
pass on the benefits to the consumers. As regards, SO 1405(E), dated
12.4.2016, while notifying the said SO, NPPA has not taken into account
the WPI impact. In view of the above, NPPA has fixed the ceiling prices
strictly as per the provisions of DPCO, 2013, and the grievances raised
by petitioner company has no merit and the review application may be
rejected.
“NPPA has fixed the ceiling prices strictly as per the
provisions of DPCO, 2013, and the grievances raised by petitioner
company have no merit and the review application stands rejected,” the
DoP ordered.
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