Refix ceiling price of Sun Pharma's ciprofloxacin 250mg, 500mg tablets: DoP tells NPPA

The Department of Pharmaceuticals (DoP) has given its decision in favour of Sun Pharma against the price fixing of ciprofloxacin 250mg and ciprofloxacin 500mg tablets and has directed the National Pharmaceutical Pricing Authority (NPPA) to revise the ceiling price of both the drugs.

Sun Pharma had filed two petitions under paragraph 31 of the Drugs (Prices Control) Order, 2013 against notification S.O. No.2401(E), dated 28.07.2017 issued by the National Pharmaceutical Pricing Authority (NPPA) fixing the ceiling price of Ciprofloxacin 250mg and Ciprofloxacin 500mg tablets.

It is reported that NPPA had revised the price of Ciprofloxacin 250mg tablets to Rs. 1.89 per tablet and Ciprofloxacin 500mg tablets to Rs 3.31 per tablet. This was challenged by Sun Pharma contending that the NPPA's working sheet captured incorrect price to retailer (PTR) in the case of ciprofloxacin 250 mg tablets.

The petitioner had stated that 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. The company had submitted the required details.

Sun Pharma further contended in case of ciprofloxacin 500mg tablets 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 percent 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 petitioner has further claimed that the product CIFRAN OD 500 MG TABLET 5 is an incrementally innovated formulation, thus should not have been captured in ceiling price calculation as per explanation (2) of Department of Pharmaceuticals' notification S.O. 701 (E) dated 10.03.2016. Generally, 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. A patient would need lesser doses of OD formulation compared to conventional formulation in completing the therapy. Thereby, pricing of OD formulation should be exclusive and excluded from conventional formulation.

However, during the proceedings, NPPA stated that in respect of the product Ciplox OD 500 of Cipla, the brand Ciplox has more than 1 percent 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.

At the time of examination, DoP noted that in case of ciprofloxacin 250 mg tablets, 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 in case 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 percent market share and said the PTR of Ciplox OD 500 mg tablet 5 of Cipla having MAT value of less than 1 percent market share should not be considered while fixing the ceiling price of the subject formulation.

Giving the decision, DoP stated,

"NPPA is hereby directed to examine the information/documentary proof, i.e. MAT and PTR data of CIFRAN 250mg tablets 10's pack along with sample packs, invoices to retailer and summary of all invoices issued for the month of August 2015, submitted by the petitioner company, and after verification, refix/revise the ceiling price of Ciprofloxacin 250mg, on merit."

"NPPA is further directed to revise the ceiling price of Ciprofloxacin 500mg tablets, considering only the brands and generic versions of the medicine having market share more than or equal to 1% of the total market turnover on the basis of MAT of that medicine."

"NPPA is also directed to refer the matter to the Expert Committee to examine and recommend whether separate ceiling price can be considered for Cifran OD 500mg tablet, based on lesser doses of OD formulation compared to conventional formulation in completing the therapy. Thereafter, the recommendation of the Expert Committee may be examined by NPPA to take a decision about refixation of separate ceiling price of Cifran OD 500 MG tablet, containing Ciprofloxacin 500mg, on merit."

"The above directions be implemented within a period of thirty days from the date of issue of this order and compliance report be submitted."

Below is the attachment for the same.