|
NPPA notifies recalculated ceiling price of anti-malaria drug chloroquine phosphate 150 mg
|
|
Gireesh Babu, New Delhi
September 18 , 2024
|
|
|
The National Pharmaceutical Pricing Authority (NPPA) has notified the 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 company argued before the review authority that it 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.
Finalising the revised price, the NPPA in its recent Authority meeting observed that Bayer Zydus Pharma did not file the Form II for the year 2022-23 and the company was granted discontinuation permission by the Authority in March, 2020. The last Form II filed by Bayer Zydus Pharma was on April 20, 2021.
The Authority sought clarification from the company and received a response that the last batch of the drug was produced by Bayer Zydus Pharma in October, 2021 with expiry in September, 2024 and the PTR as per the Form II and Form V submitted on in April and August, 2021 was Rs. 9.99 for 10 tablets.
IPCA's Price to Retailer in Form II was wrongly considered at Rs. 13.83 instead of Rs. 10.54, it added.
The authority, in its latest meeting held on September 9, noted that the revised draft working sheet with ceiling price of Rs. 1.33 per tablet was uploaded on website on July 31, 2024 after giving effect of WPI increase of 12.1218 per cent with effect from April 1, 2023 and WPI increase of (+) 0.00551% with effect from April 1, 2024 and no representations were received on it.
"Accordingly, the Authority approved the revised ceiling price with WPI effect at Rs. 1.33 per tablet," it added. Following the meeting the order has been notified in the Gazette of India.
The company in its review application 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.
It 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 during the review process 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.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|