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.