Last Updated on October 9, 2024 by The Health Master
Malaria
The Department of Pharmaceuticals (DoP) has identified an error in the ceiling price set by the National Pharmaceutical Pricing Authority (NPPA) for chloroquine phosphate 150mg tablets, a vital medication for malaria treatment.
This news is significant for both pharmaceutical companies and patients seeking access to affordable antimalarial drugs.
IPCA Laboratories Challenges NPPA’s Pricing
In February 2023, IPCA Laboratories, a leading manufacturer of chloroquine phosphate tablets in India (after Bayer Zydus Pharma discontinued their product “Resochin”), filed a review application with the DoP.
The application contested the ceiling price set by NPPA for their “Lariago” tablets containing 150mg of chloroquine phosphate.
Grounds for the Challenge
IPCA argued that NPPA made several mistakes in calculating the ceiling price.
Here’s a breakdown of the key points:
Outdated Market Data:
IPCA claimed NPPA relied on inaccurate market data from Pharmatrac for “Resochin” tablets.
This data reportedly reflected a price much lower than the actual price Bayer Zydus Pharma charged before discontinuing the product.
Discontinued Product Shouldn’t Impact Pricing:
IPCA pointed out that “Resochin” was no longer available, and its historical price shouldn’t be factored into calculating the ceiling price for their “Lariago” tablets.
Incorrect PTR for IPCA:
IPCA asserted that NPPA used the wrong Price to Retailer (PTR) for their product. The company had submitted a revised PTR in April 2022, which wasn’t considered by NPPA.
Impact on Availability of Chloroquine Phosphate
IPCA expressed concern that the incorrectly set ceiling price would make it financially unviable to continue producing “Lariago” tablets.
This could lead to a shortage of this crucial antimalarial medication in India.
NPPA Acknowledges Errors
In response to IPCA’s challenge, NPPA admitted to making mistakes in their calculations.
Here’s a summary of their acknowledgment:
Outdated “Resochin” Data:
NPPA confirmed that they relied on outdated data from Pharmatrac for “Resochin” tablets. They recognized that the last accurate PTR submitted by Bayer Zydus Pharma should have been used.
Incorrect PTR for IPCA:
NPPA agreed they used the wrong PTR for IPCA’s “Lariago” tablets. The correct PTR, as submitted by IPCA in April 2022, should have been considered.
Recalculation Ordered
Based on the acknowledged errors, the DoP has directed NPPA to recalculate the ceiling price for chloroquine phosphate 150mg tablets.
This recalculation should be based on the most recent and accurate data available, considering:
- The last PTR submitted by Bayer Zydus Pharma before discontinuing “Resochin.”
- The correct PTR submitted by IPCA Laboratories for their “Lariago” tablets.
The DoP has also urged NPPA to be more vigilant in identifying and rectifying such errors during future ceiling price calculations for essential medications.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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