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NPPA refuses to change ceiling price of VHB Life Sciences' rheumatoid arthritis drug
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Gireesh Babu, New Delhi
August 14 , 2024
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The National Pharmaceutical Pricing Authority (NPPA) has decided not to change its ceiling price calculation for rheumatoid arthritis drug Artamin 250 mg capsule 10's containing penicillamine 250 mg from Maharashtra-based VHB Life Sciences Ltd even though the company received a favourable order from the Department of Pharmaceuticals (DoP) in its review application earlier.
The Authority observed that the company failed to submit the details of the revised prices for the scheduled formulation from 2018 to 2021 on time and were filed together on March 8, 2022, in violation of the time limit prescribed under the Drugs Prices Control Order (DPCO), 2013.
NPPA fixed the ceiling price of the drug at Rs. 13.96 per capsule on January 11, 2023, after publishing the working sheet on December 13, 2022 inviting comments from the industry in 10 days from the date of publication of the working sheet.
VHB Life Sciences approached the DoP with review petition requesting for consideration of correct price-to-retailer (PTR) of their brand after implementation of wholesale price index (WPI) in the month of April, 2022 and submitted its Form II and Form V filing on April 16, 2022 as per the requirements.
The DoP, accepting the company's argument that the price was fixed without considering the revised PTR, even though a representation was not filed by the company in the 10-day timeframe, referred the matter back to the Authority for recalculation of the prices of the formulation.
However, the Authority found that although the Form II with the details of the revised prices for the scheduled formulation was submitted for the year 2022, the same for four previous years from 2018 to 2021 were filed on March 8, 2022, which is not within the time limit prescribed under the DPCO, 2013.
It noted that as per the Para 16 (2) and (3) of the DPCO, 2013, the manufacturers can increase the MRP of the scheduled formulations once in a year on the basis of WPI of the previous year with prior approval of the government, and the price revision shall be forwarded to the government in Form II within a period of 15 days of such revision.
"...non-submission of information under this sub-paragraph shall be construed as non revision of maximum retail price (MRP) and the concerned manufacturer shall be liable to deposit the amount charged over and above the pre-revised maximum retail price (MRP), along with interest thereon from the date of overcharging," says Para 16(3) of DPCO.
The Authority, in its latest meeting, observed that DoP has directed to recalculate the prices of the formulation as per the provisions of the DPCO, 2013, but the company has contravened the Para 16(3) in filing Form II during 2018-21 and hence, the PTR revision in these years are invalid.
"Consequently, the PTR revision in April, 2022 is also invalid and cannot be considered for ceiling price fixation, although Form II has been filed within the prescribed timelines. Thus, keeping in view the DPCO, 2013 provisions, the Authority decided that the PTR as appearing in the July, 2022 market database should be considered for fixing the ceiling price," said the NPPA.
Subsequent to this, the Authority noted that the recalculated ceiling price based on PTR of July, 2022 would be the same as the earlier notified price.
"Since, no change in recalculated ceiling price is observed, hence no fresh notification is needed," it concluded.
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