New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of malaria drug chloroquine phosphate 150 mg, following a direction from the Department of Pharmaceuticals (DoP) to recalculate the price observing that the pricing authority has erred in calculation. The DoP’s review order on May 28 was in favour of an application filed by IPCA Laboratories.
The revised calculation fixes the ceiling price of the drug at Rs. 1.33 per tablet, as compared to Rs. 1.04 per tablet notified by the Authority through a notification on January 11, 2023. The revised calculation sheet has considered the price of IPCA’s drug Lariago, at Rs. 1.05 as the maximum price for calculation of the ceiling price.
The review order was issued on May 28, 2024, following an application filed by IPCA Laboratories in February, 2023 following ceiling price fixation announced for the company’s Lariago tablet containing chloroquine phosphate 150 mg.
The company in its review application said that the NPPA has erred in determining ceiling price of the drug and hence the DoP may direct the authority to reverse the same on certain grounds.
It argued that the company has already in October, 2022 informed NPPA that the Price to Retailer (PTR) reflected in market data provider Pharmatrac’s data for the drug are grossly incorrect for Resochin tablets, marketed by Bayer Zydus Pharma. It also informed the price regulator that Bayer Zydus Pharma has discontinued the drug and its price should not be considered in calculating the average PTR.
The company alleged that despite providing proof regarding revised prices and the PTR, NPPA in a draft worksheet uploaded on January 12, 2023, considered the old PTR of Resochin tablet as Rs. 0.65 per tablet.
The company claimed that they are sole manufacturers of chloroquine phosphate 150 mg tablets in India after discontinuation of resochin tablets, and incorrect ceiling price fixed on January 11, 2023 will leave the company to apply Form IV for discontinuation of the product Lariago tablets from the market.
NPPA agreed that there were mistakes in its calculation. It said that the Pharmatrac database showed price of resochin tablets priced at Rs. 6.46 per 10 tablets, which is without Wholesale Price Index (WPI) increase, while the last Form II was filed by Byer Zydus Pharma in April 20, 2021 with PTR of Rs. 9.99 for a pack of 10 tablets.
It also stated that in case of IPCA Laboratories, the correct PTR is Rs. 10.54 per 10 tablets, which is Rs. 1.05 per tablet on the basis of Form II submitted by the company on April 12, 2022. However, the Authority has inadvertently considered the price of Rs. 13.83 per 10 tablets for the company and this also needs to be rectified so as to reflect the correct PTR of Rs. 10.54 per 10 tablets.
The review authority observed that during the hearing, NPPA acknowledged that inadvertently, the last Form II filed by Bayer Zydus Pharma before discontinuation of the product was not considered by the price regulator during the ceiling price fixation. Similarly, the PTR of IPCA Laboratories was also not considered correctly.
“Therefore, the ceiling price for the formulation chloroquine phosphate 150 mg required recalculation based on revised PTR. NPPA may once again look out for all such possible errors in calculation of ceiling price,” said Awadhesh Kumar Choudhary, senior economic adviser to the Department of Pharmaceuticals in the review order.
“In the backdrop of above facts, the case is being referred back to NPPA for recalculation of ceiling price of chloroquine phosphate 150 mg tablet as per the extant provisions of DPCO, 2013,” added the order.
