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NPPA ordered to refix ceiling price of Sun Pharma’s ciprofloxacin 250mg, 500mg tablets
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Arun Sreenivasan, New Delhi
March 06 , 2018
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The Department of Pharmaceuticals (DoP) has directed the National
Pharmaceutical Pricing Authority (NPPA) to revise the ceiling price of
Sun Pharmaceuticals’ ciprofloxacin 250mg and ciprofloxacin 500mg tablets
after examining data and documentary proof submitted by the drug maker.
Sun
Pharma, in its review petition, contended that the regulator’s working
sheet captured incorrect price to retailer (PTR) in the case of
ciprofloxacin 250 mg tablets. “In the working sheet, PTR of Cifran 250
mg tablet 10 was captured as Rs.16.76 per
pack of 10 tablets. However the correct PTR applicable in the month of
August 2015 was Rs.18.63 per pack of 10 tablets,” the drug maker claimed
in its plea.
The company further added that though it had
submitted the required details, the correct PTR of Cifran 250 mg tablet
10 applicable in the month of August 2015 was not considered by the
regulator in ceiling price calculation.
Regarding ciprofloxacin
500 mg tablet pricing, the company said the NPPA should have considered
market shares of only brands or generic versions of the medicine and not
company wise moving annual turnover (MAT) percentage. However, Ciplox
OD 500 mg tablet 5 of Cipla Ltd having less than 1 per cent market share
was captured in the ceiling price calculation. Moreover, Cifran OD 500
mg tablet 5 is an incrementally innovated formulation. It should not
have been included in ceiling price calculation as per DoP notification.
The dose frequency of Cifran conventional formulation is twice a
day, while that of Cifran OD is once a day in effecting the same level
of treatment. Patient would need lesser doses of OD formulation compared
to conventional formulation to complete the therapy. Therefore the
pricing of OD formulation should be exclusive and excluded from
conventional formulation, the company added.
Countering Sun
Pharma’s argument, the NPPA stated: “In respect of the product Ciplox OD
500 of Cipla, the brand Ciplox has more than 1 per cent market share
and hence considered in the calculation of ceiling price. Ciplox OD 500
mg and Cifran OD 500mg are included in the price calculation sheet as
per the decision of 27th Authority Meeting which states that all
variants of the product is to be taken while calculating the price
fixation of the formulation unless different variants of the
formulations are specially mentioned against any formulation in NLEM,
2015.”
During examination of the plea regarding ciprofloxacin 250
mg tablets, the DoP observed that the company had submitted necessary
documents in support of the actual PTR of its product and should not be
deprived of their claim by not considering the actual PTR.
While
reviewing the pricing of ciprofloxacin 500mg, the department pointed
out that DPCO, 2013 does not allow averaging of all brands of a company
but provides for averaging only of brands with more than 1 per cent
market share. “Therefore, the PTR of Ciplox OD 500 mg tablet 5 of Cipla
having MAT value of less than 1 per cent market share should not be
considered while fixing the ceiling price of the subject formulation,”
it said.
Finding merit in the drug manufacturer’s petition, the
DoP asked the price regulator to examine the MAT and PTR data of Cifran
250mg tablets along with sample packs and invoices to retailer and
revise the ceiling price of ciprofloxacin 250mg. The NPPA was also
directed to revise the ceiling price of ciprofloxacin 500mg tablets,
considering only the brands and generic versions of the medicine having
market share of more than or equal to 1 per cent of the total market
turnover on the basis of MAT of that drug.
The regulator was also
ordered to seek the help of the expert committee to see whether
separate ceiling prices can be considered for Cifran OD 500mg tablet and
Cifran conventional formulation. On the basis of the recommendation of
the panel, the NPPA can take a decision about refixation of separate
ceiling prices, the DoP order stated.
Ciprofloxacin 500 mg tablet
is used to treat a variety of bacterial infections such as bronchitis,
pneumonia, gonococcal infection and certain types of infectious
diarrhea. The medicine can also be used to treat urinary tract
infections and anthrax.
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