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DoP rejects review application of Sun Pharmaceuticals on ceiling prices of ciprofloxacin HCl tablet 250 mg
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Ramesh Shankar, Mumbai
December 07 , 2016
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The Department of Pharmaceuticals (DoP) has rejected the review
application of pharma major Sun Pharmaceuticals Industries filed against
the fixation of ceiling price of “Ciprofloxacin HCl tablet 250 mg” by
the National Pharmaceutical Pricing Authority (NPPA). The NPPA had
earlier fixed the ceiling price of “Ciprofloxacin HCl tablet 250 mg”
through its notification S.O. No. 1882(E) dated 13/7/2015 issued under
DPCO, 2013.
The main grievance of the company was that the data
considered by NPPA was pertaining to September, 2013 while the
notification was issued by them in September, 2014, which is one year
later while the period is six months as per DPCO, 2013. Further, the
company stated that they did not avail any WPI. However, WPI was due to
for the year 2012 as well as 2013. Company representative further
referred the Bombay High Court Order dated 14.1.2005 in WP No.6135/03
vacated the interim orders, if any. The company further referred to the
Bombay High Court Order dated 15.3.2005 vide which the ad interim order
dated 20.3.2003 stood revived.
The company referred to the
Bombay High Court Order dated 22.6.2006 by which the petition of the
company was dismissed. Civil application of the company was also
disposed off. The company mentioned that there is no order stating that
interim orders of 20.10.2003 stand vacated. The company also referred to
the Order dated 27.6.2006 vide which civil application of the company
was restored and there is no order to the vacation of interim order. The
company mentioned that as per Order dated 20.10.2003 granting an
interim stay to the company, the company is not required to follow the
ceiling price notified by NPPA.
In reply, the NPPA clarified that
at the outset price fixation of essential medicines of ciprofloxacin
250 mg has been carried out by NPPA in accordance with the provisions of
DPCO, 2013. There is no bar neither in 2013 nor it was in DPCO 1995 to
carry out price fixation of ciprofloxacin. NPPA denied the contention of
the review applicant as NPPA has carried out price fixation in 1995 in
accordance with the provisions of DPCO, 1995 which were continuing till
the promulgation of DPCO, 2013. In accordance with the provisions of
para 10 of DPCO, 2013, NPPA has carried out the price fixation of
ciprofloxacin as per policy listed in 1995.
Ceiling prices fixed
by the company for ciprofloxacin were carried out in 2013 as per para
10 of DPCO 2013. As regards the contention of petitioner company about
continuing the stay in respect of Writ Petition 6135 of 2003 in Bombay
High Court, NPPA stated that no stay was continuing as per available
information, and requested the company to give the copies of that, which
was not given to them. However, petitioner company forwarded certain
copies of the judgements, which were not relevant and cannot be extended
in this case.
During examination of the matter, the DoP noted
that the points raised by the company regarding the data, it is
mentioned that as per provisions of para 10(1) of DPCO 2013, the price
of common formulations under DPCO, 1995 and 2013 fixed and notified upto
31st May, 2012 have to remain effective for one year i.e. upto 31st
May, 2013 and the manufacturers may revise the prices of such
formulations as per WPI for the previous calendar year i.e. January 1,
2012 to 31.12.2012. In this paragraph, the WPI increase has been left to
the manufacturers and if for commercial reasons, some companies choose
not to avail WPI increase, it cannot be provided while fixing the
prices. After taking the data of September, 2013, the prices are
required to be fixed as per para 4(1). In the instant case, company did
not avail WPI. Therefore, they have no merit in claiming WPI increase
for 2012.
As regards the petitioner company’s point of WPI for
2013, the DoP noted that it may be seen from calculation sheet that NPPA
has already provided WPI for 2013 in 2014. Hence, the point raised by
the company has no merit.
Another point raised by the company
that prices under para 10 read with para 4 of DPCO 2013 have to be fixed
by taking PTR of all formulations having market share of 1% is not
maintainable as the price notified by NPPA under DPCO 1995 have not been
quashed by the Court. Only a direction to NPPA has been given against
any coercive action that too against a bank guarantee of difference in
the notification and selling prices. Therefore, any price which is
subject to review by the Court cannot be considered for price fixation
until it reaches finality.
Further, the three options suggested by the petitioner during the personal hearing given on 7.6.2016 have no merit.
After
hearing, the DoP ordered, “In view of the examination above, the review
application of the company has no merit and is dismissed”.
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