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Cipla gets favourable ruling from DoP on its review petition on amlodipine, ciprofloxacin & azithromycin formulations
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Ramesh Shankar, Mumbai
June 01 , 2017
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The Indian pharmaceutical major Cipla Ltd has has received favourable
ruling from the Department of Pharmaceuticals (DoP) on its three
formulations as the DoP has directed the NPPA to refix the ceiling
prices of the formulations amlodipine 5 mg, ciprofloxacin 250 mg and 500
mg and azithromycin 250 mg & 500 mg.
Earlier, Cipla had
filed a review application against price fixation of “Amlodipine 5 mg,
ciprofloxacin 250 mg and 500 mg., azithromycin 250 mg & 500 mg.” by
NPPA vide its order No. S.O. 1686(E), dated 09.05.2016 issued under DPCO
2013.
During the examination of the review petition, the
reviewing authority DoP noted that the main contentions of the company
are that the ceiling prices of the aforesaid formulations should not be
revised as the formulations were in NLEM 2011 and continue to be
included under the revised NLEM 2015. Ceiling prices of the above
mentioned formulations were already in force prior to issuance of SO
No.1686(E) dated 09.05.2016. Further, only those brands having more
than 1% market share should be considered for the purpose of calculation
of the ceiling prices.
As regards the contention of the
petitioner company that ceiling prices for the medicines “added” in the
NLEM 2015 have to be fixed and not for the products which are already in
NLEM 2011, it is stated that Para 18(i) of DPCO 2013 clearly states
that the revision of ceiling prices on the basis of moving annual
turnover value shall be carried out “as and when the National List of
Essential Medicines is revised by the Ministry of Health and Family
Welfare or five years from the date of fixing the ceiling price under
this Order whichever is earlier.”
In view of this, NPPA has
revised the ceiling prices of the formulations, mentioned in amended
list of scheduled formulations, strictly as per the provision of DPCO
2013. Therefore, the petitioner company has no merit in this contention,
the DoP noted.
Regarding the contention of the petitioner
company about the criteria for fixing ceiling price of the subject
formulations, on examination, it is found that NPPA has erred in
calculating ceiling price as per para 4 of DPCO, 2013, which reads as
under :- “4. Calculation of ceiling price of a scheduled formulation (1)
The ceiling price of a scheduled formulation of specified strengths and
dosages as specified under the First Schedule shall be calculated as
under:- Step 1: First the Average price to Retailer of the scheduled
formulation i.e. P(s) shall be calculated as below:- Average Price to
Retail P(s) = (Sum of prices to retailer of all the brands and generic
versions of the medicine having market share more than or equal to one
percent of the total market turnover on the basis of moving annual
turnover of that medicine)/(Total number of such brands and generic
versions of the medicine having market share more than or equal to one
per cent of total market turnover on the basis of moving annual turnover
for that medicine).” It clearly mentions the medicines which are to be
taken for calculation.
In the instant case, the principles
applied by NPPA go beyond what is mentioned in DPCO. Hence, NPPA may be
directed to refix the ceiling price in accordance with the provisions of
DPCO. The DPCO does not recognise a company for average PTR but only
medicines/ formulations. Thus, only those formulations are to be
considered, which are having MAT value of more than 1% market share.
In
view of the above, the contention of the petitioner company, that
ceiling prices for the medicines “added” in the NLEM 2015 have to be
fixed and not for the products which are already in NLEM 2011, has got
no merit as NPPA has revised the ceiling prices in accordance with the
provisions of para 18(i) of DPCO, 2013. However, NPPA may be directed to
refix the ceiling prices of the formulations by considering only those
medicines/formulations having MAT value of more than 1% market share, as
DPCO does not recognise a company for average PTR but only
medicines/formulations.
After examining the case, the DoP
orderes, “NPPA is hereby directed to refix the ceiling prices of the
formulations amlodipine 5 mg, ciprofloxacin 250 mg and 500 mg.,
azithromycin 250 mg & 500 mg. by considering only those
medicines/formulations having MAT value of more than 1% market share, as
DPCO does not recognise a company for average PTR but only
medicines/formulations.”
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