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DoP upholds NPPA's ceiling price fixation for heart disease drug formulation Dobustat
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Our Bureau, New Delhi
October 30 , 2024
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The Department of Pharmaceuticals (DoP) has upheld the ceiling price fixation of National Pharmaceutical Pricing Authority (NPPA) for cardiovascular medicine Dobustat 250 mg injection 5 ml containing dobutamine injection 50 mg/ml, rejecting a review application filed by Mumbai-based Samarth Life Sciences.
The company approached the DoP with a review application in April, 2023, after the NPPA issued an order fixing the price of dobutamine injection 50 mg/ml in March, 2023. Samarth is engaged in manufacturing and marketing of the brand Dobustat 250 mg injection 5 ml containing the scheduled formulation.
It argued that the ceiling price calculation of this formulation must be on the basis of each ml and not each pack.
Earlier NPPA had issued a decision relating to the ceiling price fixation of the scheduled formulation, stating that 'each pack' should be read as '1 ml'. The company disputed that its formulation is not sold in a pack of 50 mg, but rather in a pack of 5 ml.
It argued that in the draft working sheet, it is mentioned that the formulation should have the strength of 50mg/ml and pricing a liquid injection on the basis of 'each pack' is arbitrary and against the provision under the DPCO, 2013.
The Para 11(1) of DPCO states that the average price to retailer calculated as per the provisions in the paragraphs shall be on the dosage basis, (per tablet, per capsule or injection in volume listed in first Schedule) and the ceiling price or retail price of a pack shall be reached by multiplying the same with the number or quantity in the pack as the case may be.
Besides, it argued that as per the sections of National List of Essential Medicines (NLEM) 2022, dobutamine injection 50mg/ml is specified and not a powder for injection which disregards the level of dilution. The company demanded that in the light of these arguments, the ceiling price calculation of dobutamine injection 50 mg/ml must be on the basis of 'each ml' and not 'each pack'.
NPPA submitted that the review is not tenable, pointing out that while it has earlier mentioned that in the ceiling price fixation, 'each pack' should be read as '1ml', as per the Wholesale Price Index (WPI) notification in February 2015, the prices were revised by WPI and notified again for each pack.
The Authority said that it considered Samarth Life Sciences' product Dobustat 250 mg injection 5 ml as a pack of 5 ml making the effective strength of formulation as 50 mg/ml as mentioned in the schedule.
Besides, the Authority said that it has considered the issues raised in the review petition earlier after the company filed a representation, and approved the ceiling price of the formulation at Rs. 8.05 per ml, after that.
The review authority observed that the price was fixed on a per ml basis under NLEM, 2022, after the price regulator considered representations from the companies. It also observed that according to DPCO, the ceiling price of the scheduled medicines is to be fixed by calculating simple average of market prices of all brands of the drug which has market share of one per cent or more and the average Price to Retailer (PTR) shall be on a dosage basis.
"NPPA has adhered to both these provisions of DPCO. It has taken prices of the available brands fulfilling the criteria as laid down by DPCO and also notified unit price on per ml basis for the aforesaid scheduled drug," said DoP.
With this observation, the review authority upheld the action of NPPA fixing the ceiling price as per the notification in March, 2023, and rejected the review application.
Dobustat 250 mg injection is a medicine used to treat patients with low cardiac output, decompensated heart failure and myocardial infarction, among others, according to online pharmacy stores.
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