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DoP raps NPPA for its decision in fixing ceiling price on methyldopa-500mg
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Ramesh Shankar, Mumbai
November 02 , 2017
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The Department of Pharmaceuticals (DoP) has taken exception to the
arbitrary decision took by the national drug price regulator National
Pharmaceutical Pricing Authority (NPPA) in fixing the ceiling price of
methyldopa 500mg tablets not adhering to the direction issued by the DoP
on 5.1 2017.
“It is seen that NPPA's Authority has taken an
arbitrary decision in its meeting held on 9.3.201 7, by not adhering to
the direction issued by DoP on 5.1.2017. Therefore, NPPA may once again
be directed to implement the Review Order No.31015/5/2016-PI.I, dated
5.1.2017 in its true spirit and fix the retail price of the formulation
methyldopa tablet 500mg as per para 4(1) and para 6 of DPCO, 2013, and
submit the compliance report”, the DoP recently directed the NPPA after
examining a review application filed by Mumbai-based pharma major
Wockhardt Ltd.
In the review application, Wockhardt contended
that the ceiling price fixed by NPPA in its meeting on 29 March 2017 is
without application of mind, and is totally contrary to the rules and
procedure stipulated under the DPCO 2013, specifically, Paragraphs 4 (1)
and Paragraph 6. The final ceiling price fixed by the NPPA
arbitrarily reduces the price of the formulation to Rs. 4.33/ tablet from the proposed ceiling price of Rs.
13.90/ tablet initially proposed by virtue of O.M. No.
8(34)/2016/DP/NPPA/Div.ll dated 21.02.2017. The final ceiling price
fixed by the NPPA reduced the price of the formulation by Rs. 9.57. The NPPA provided no reason or explanation for deviating from its own proposed price of Rs. 13.90/ tablet on the basis of its calculations.
By
disregarding the proposed price, and establishing an arbitrary price
without justification vitiates the due process of law as laid down in
DPCO 2013, and violates our rights, the petitioner further contended.
During
examination of the case, the DoP noted that the price of Methyldopa
500mg was earlier fixed by NPPA vide SO No.1254(E), dated 29.3.2016,
against which the company filed a review petition. DoP issued Review
Order on 5.1.2017 directing NPPA to re-fix/revise the ceiling price of
methyldopa 500mg as per para 4(1) and para 6 of DPCO, 2013. Based on
DoP's direction, NPPA, while revising the ceiling price of the subject
formulation placed draft working sheet on its website on 21.02.2017
proposing the ceiling price as Rs.
13.90/tablet. The company did not make any representation against the
proposed ceiling price in draft working, as the company was fully
satisfied with the proposed revision. However, before notifying the CP,
the NPPA placed the matter before the Authority Meeting on 9.3.2017. In
the Authority Meeting, a decision was taken to fix the ceiling price of
the subject formulation as Rs. 4.33/tablet, after giving negative WPI impact on the price of Rs. 4.46/tablet, fixed earlier vide SO 1254(E), dated 29.3.2016.
Based
on the decision taken in the Authority Meeting, NPPA notified the price
vide SO 787(E), dated 10.3.2017. In that way, NPPA has given no
cognizance to the Review Order, dated 5.1.2017, issued by DoP. However,
in the implementation report, NPPA stated that the Review Order stands
implemented. Wockhardt is the only company, which is manufacturing
methyldopa tablet 500mg and there is no other competitor. It may be
worth mentioning here that the company has now already served a notice
period of 6 months by submitting an application on 6.4.2016 as per Form
IV for discontinuation of this product under para 22 of DPCO,2013.
Keeping
in view the facts mentioned above, it is seen that NPPA's Authority has
taken an arbitrary decision in its meeting held on 9.3.201 7, by not
adhering to the direction issued by DoP on 5.1.2017. "NPPA is directed
to strictly implement the Review Order No.31015/5/2016-PI.I, dated
5.1.2017 and fix the retail price of the formulation methyldopa tablet
500mg as per para 4(1) and para 6 of DPCO, 2013, and submit the
compliance report," the DoP in its order said.
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