DoP Declined Biocon’s Request To Review Ceiling Price Of Trastuzumab

The Department of Pharmaceuticals (DoP) has turned down a review filed by Biocon Limited against the ceiling price fixed by the National Pharmaceuticals Pricing Authority (NPPA) for its trastuzumab injection 400mg/50ml. The national drug price regulator had amended the price of the formulation based on the multiplication factor 0.95905 to Rs. 54,582.25.

The major pharma pleased that the use of multiplication factor 0.95905 was “incorrect and untenable” since the said product was exempted from excise duty.

It might be noticed that the controller fixed prices of specified pharma formulations after excluding the excise duty levied preceding GST regime by applying a factor of 0.95905 on prevailing prior prices wherever applicable.

To substantiate its claim, the company has quoted an NPPA office memorandum which expresses that “if there should begin a circumstance of scheduled formulations, no multiplication factor would be relevant. The existing ceiling price would be exclusive of GST rates as relevant.”

DoP Declined Biocon's Request To Review Ceiling Price Of Trastuzumab

“The organizations were coordinated to contribute a list of scheduled formulations with excise duty exemption applicable as on August 31, 2015. A perusal of the notice makes it evident that the date for the thought of the status of excise exemption was August 31, 2015, and for the formulations which were an obligation on the said date, no revision of their prices would be needed,” it said.

 

In its review petition, the drug maker has asked for the DoP to pass a speaking order exclusive of GST to change the ceiling price of trastuzumab injection 440 mg/50 ml to Rs. 56,912.8 by applying a multiplication factor of 1. During the procedures, the NPPA adhered to its guns saying the ceiling price of trastuzumab injection was notified according to DPCO, 2013. The DoP acknowledged the perspectives of the controller.

“The calculation was based on August 2015 data when the formulations were excise exempted when the ceiling price was suggested. In January 2017, excise duty was first made applicable on the previous formulations. During the implementation of GST in June 2017, the NPPA reduced the ceiling price to provide an effect for removal of excise duty without citing to any provision under DPCO 2013 which allowed for such a reduction in the ceiling price of scheduled formulations because of a reduction in excise duty,” it observed.

Comprehensively rejecting Biocon’s argument, the DoP observed.

“Exact of or exclusion from any duties doesn’t matter to fixation or revision of ceiling prices under the provisions of DPCO, 2013. The ceiling prices are fixed on market-based data and not with respect to cost-based data. Any request for revision or refixation of ceiling prices by virtue of any modification in the applicable duty rates isn’t legitimate under the provisions of DPCO, 2013.”

“Applying variable of 0.95905 by the NPPA while reexamining the ceiling price of the post-GST regime is all together. Subsequently, the request of the company can’t be considered and the review application stands rejected,” it expressed.

Trastuzumab injection is used to treat HER2-overexpressing new or metastatic breast cancer. It can be used alone or with other cancer drugs.

Biocon is an innovation conducted completely integrated biopharmaceutical company situated in Bangalore that has developed reasonable biosimilars, novel biologics, and complex APIs. It’s a pioneer in fermentation-based biopharmaceuticals.

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