The Department of Pharmaceuticals (DoP) has rejected the Sun Pharmaceutical Industries' review petition against fixing of ceiling price for the formulation 'Ondansetron 8mg tablet.
Earlier, the National Pharmaceutical Pricing Authority (NPPA) had fixed the ceiling price of ondansetron 8 mg tablet vide its notification S.O. No. 2193(E)[corrected SO No.2195(E)] dated 23.06.2016 issued under Drugs (Prices Control) Order, 2013 (DPCO, 2013). Aggrieved by the notification, the Sun Pharmaceutical Industries filed a review petition against the NPPA notification.
In the review petition, the petitioner stated that he price calculation shown in working sheet captures our 3 formulations – 2 plain tablets (zofer 8 mg tablet 4, zofer 8 mg tablet 10) and 1 mouth dissolving (MD) tablet (zofer md 8 mg tablet MD 10). As mouth dissolving tablets have added benefits over plain tablets like rapid onset of action, improved bioavailability, lesser side effects, these should not have been clubbed with plain formulation of ondansetron tablets while calculating the revised ceiling price. Hereby, we submit that we are aggrieved with this notification and, we therefore seek a review of the same under paragraph 31 of DPCO 2013.
It further contended that the working sheet showing calculation of ceiling price displayed on the website of NPPA on 28.06.2016 incorrectly captures mouth dissolving tablets, and sustained release tablets. As per calculation shown in working sheet, it is apparent that total 12 packs, having 1% market share or above were considered in calculating ceiling price. On careful observation, it was found that 4 packs out of 12 are either SR (sustained release) formulation, or MD formulation (mouth dissolving)- including one of Sun Pharma, and hence should not have been considered in ceiling price calculation, as per explanation (2) of Department of Pharmaceuticals’ notification S.O. 701 (E) dated 10.03.2016. Thus the ceiling price notified as Rs. 9.06 per tablet should not be applicable to Zofer MD 8 mg tablet (ondansetron 8 mg tablet).
In reply, the NPPA stated that there is no provision of separate pricing for ondansetron 8mg tablet (Conventional & Mouth Releasing/Sustained Releasing tablet) in NLEM, 2015. Therefore, the request of company to review the ceiling price for the subject formulation is not tenable.
During examination, the reviewing authority DoP noted that in the instant case, the only contention of the company is that NPPA has considered the data of 4 packs out of 12, which are either SR (Sustained Release) formulation, or MD formulation (Mouth Dissolving) - including one of Sun Pharma, while fixing the ceiling price of the formulation Ondansetron Tablet, which is a plain tablet. According to the petitioner company, the PTR of SR formulation or MD formulation should not have been considered, while fixing the ceiling price of plain tablet.
The description of formulations in NLEM 2015 do not provide any differential treatment about pricing of formulations having different delivery system or with extra added features. Through the amendment in the DPCO vide SO No.701(E), dated 10th June, 2016, an explanation (2) as footnote is provided, whereby “formulations developed through incremental innovation or noval drug delivery systems like lipid/liposomal formulations, sustained release/controlled release etc. should be considered as included only if specified in the list against any medicine. Such different formulations should be considered differently for purposes such as procurement policy, pricing etc.”
This explanation, however, do not categorically state that such different dosage forms are to be treated as non-scheduled for the purposes of price fixation. Furthermore, the DPCO has no separate methodology that may be adopted to arrive at a separate ceiling price of such formulations. As such, until requisite methodology is notified for the purpose to decide about the incremental innovation involved or the formula for deciding the ceiling prices, such request may not be feasible to be entertained.
In view of the above, hearing authority is of the opinion that the request of company to review the ceiling price for the subject formulation is not tenable, and the review petition may be rejected.
After hearing both the parties, the DoP ordered, “The point raised by the petitioner company in their review petition, dated 21.7.2016 against fixing of ceiling price for the formulation “Ondansetron 8mg tablet” has got no merit and stands rejected.”