Dept of Pharma upholds NPPA Price Cap on Dobustat Injection

This ruling, formalized on October 24, 2024, comes after Samarth Life Sciences filed a review application on April 25, 2023, contesting the ceiling price of the said formulation established by NPPA.

The NPPA, in its initial order issued on March 31, 2023, set the ceiling price of Dobustat, an injection containing 50 mg/ml of the active ingredient Dobutamine, at Rs. 8.05 per ml. This price, which was later revised to Rs. 9.02 per ml following a wholesale price index adjustment, prompted Samarth to raise objections.

Samarth argued that the NPPA erred in pricing, as the drug is sold in 5 ml vials, and claimed that the ceiling price should be calculated per ml rather than per pack.

Samarth Life Sciences, the company behind Dobustat 250 mg injection, challenged the NPPA’s calculation methodology, arguing it violated the Drugs (Prices Control) Order (DPCO) of 2013. The company noted that under DPCO regulations, price ceilings should be determined on a dosage basis (per unit, such as ml or tablet) and not per pack. They cited paragraph 11(1) of DPCO, which instructs that the ceiling price should reflect the dosage volume.

Additionally, Samarth referred to a 2014 NPPA corrigendum, which clarified that for similar formulations, “each pack” should be interpreted as “1 ml.” Samarth contended that the NPPA’s new method misrepresented their product by treating it as a full pack of 50 mg, despite the formulation being sold in 5 ml vials with a concentration of 50 mg/ml. This, they argued, was inconsistent with DPCO’s intent to establish ceiling prices in accordance with actual product dosing volumes.

In response, the NPPA defended its decision, stating that the price was determined according to existing rules, aligning with the schedule of the DPCO and adhering to prior revisions. According to NPPA, the formulation of Dobutamine, which is listed in Schedule I of DPCO 2013, should be priced on a per ml basis for a 50 mg/ml concentration, making the price ceiling reasonable under current guidelines.

The NPPA further clarified that the decision had already been discussed in a prior representation on February 24, 2023, and was re-evaluated during its authority meeting on March 29, 2023, leading to the price ceiling of Rs. 8.05 per ml, later adjusted to Rs. 9.02.

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After reviewing the arguments from both Samarth Life Sciences and NPPA, the Department concluded that NPPA’s decision was consistent with DPCO guidelines, upholding the original price ceiling. It observed;

“The Applicant has maintained that its formulation "Dobustat 250mg injection 5ml" is not sold in a pack of 50mg but rather pack of 5ml. NPPA clarified that it has considered the Applicant's product "Dobustat 250mg injection 5ml" as pack of 5ml making the effective strength of the formulation as 50mg/ml as mentioned in ScheduleI of DPCO, 2013. Further, considering the representations received from the companies, NPPA has fixed the ceiling price of the subject formulation on per ml basis under NLEM, 2022.”

The Department found that NPPA had correctly adhered to both paragraph 4 (regarding market price averaging) and paragraph 11 (regarding dosage basis) of DPCO when determining the ceiling price for Dobutamine injections. It noted;

“Para 4 of DPCO provides that 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 1% or more. Further, under para 11(1), DPCO also provides that the average Price to Retailer (PTR) shall be on a dosage basis (i.e. per tablet, per capsule or injection in volume as listed in Schedule-I of DPCO).”

“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.”

The review application from Samarth was therefore dismissed, affirming the existing price cap for Dobustat.