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NPPA revises calculation sheets for four scheduled formulations after review orders
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Gireesh Babu, New Delhi
June 27 , 2024
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The National Pharmaceutical Pricing Authority (NPPA) has released the revised calculation of ceiling prices for four formulations following review orders issued by the Department of Pharmaceuticals recently based on applications filed by pharma companies.
The revised ceiling price calculations has been published for antiretroviral drug lamivudine 100 mg tablets, anti-asthma drug montelukast 4 mg tablets, blood pressure lowering drug metoprolol 25 mg tablets, and antiviral drug valganciclovir 450 mg tablets, by taking the revised prices of brands manufactured and marketed by the companies into consideration.
The DoP has issued a favourable order recently in a review application filed by RPG Life Sciences for its formulation Cmvee 450 mg tablet 2's containing valganciclovir 450 mg tablets and Cardibeta XR tab 25mg 10's containing metoprolol 25 mg for which the ceiling prices were fixed through orders in December 19, 2022 and January 6, 2023, respectively.
Similarly, the DoP has come out with orders favourable to Cipla Ltd, on review applications against the ceiling price fixation order of Lamivir BV 100 mg 10 tablets containing lamivudine 100 mg and Montair 4mg 15 tablets containing montelukast 4 mg, issued on December 19, 2022.
According to the previous price calculation sheets, ceiling price of valganciclovir 450 mg tablets were fixed at Rs. 357.39 per tablet, which is now revised to Rs. 408.27 per tablet, by considering RPG's Cmvee 450 mg tablet's Price to Retailer (PTR)at Rs. 783.8. The formulation was added to the NLEM, 2022, which was incorporated into the Schedule I of the Drugs Prices Control Order (DPCO), 2013.
The price of metoprolol 25 mg was fixed at Rs. 3.75 per tablet in December, 2022. Following the review order, the ceiling price has now been calculated as Rs. 4.25 per tablet.
The ceiling price of lamivudine 100 mg tablet was notified as Rs. 9.28 per tablet in an order on December 19, 2022, and following the review order, the price has now been revised as Rs. 11.07 per tablet.
Similarly, montelukast 4 mg tablets, for which the ceiling rice was ordered at Rs. 8.95 per tablet in December, 2022, the price has been revised now at Rs. 10.23 per tablet.
In its review application, RPG Life Sciences informed the review authority that the NPPA has erred in determining the ceiling price of the drugs and requested the authority to direct the NPPA to revise the same.
The company said that it had implemented the Wholesale Price Index (WPI) change for both the formulations in April, 2022, but the prices of valganciclovir 450 mg and metoprolol 25 mg were calculated without taking the revised price of its formulations into account.
The calculation of valganciclovir 450 mg tablet must be rectified based on the PTR of Rs. 738.80 as submitted by the company in Form V and not the PTR of Rs. 679.50 taken in the calculation. Similarly, the ceiling price calculation of metoprolol 25 mg should have been fixed after considering the revised PTR for Cardibeta XR tablet 25 mg 10's at Rs. 37.54 and not Rs. 32.29, it argued.
These revised prices have now been considered in the ceiling price revision following the review order.
Similarly, Cipla alleged that the NPPA did not consider the revised PTR of its drugs, even though the company presented documents including representation letter, Form-V, invoice and pack shot within the prescribed time lines of 10 working days against the draft working sheet of the ceiling price issued on November 25, 2022.
Non-reflection of PTR in the market based data should not be construed as non-implementation of revised MRP, especially when invoices of sales and pack shots at revised MRP are provided as documentary evidence, argued Cipla, adding that the prices should not have been notified without providing manufacturers another opportunity to review the revision in draft calculation of ceiling prices.
While the price of Lamivir HBV 100 mg 10's had a revised PTR of Rs. 113.13, the PTR as per calculation made by the Authority was Rs. 102.85. Similarly, for Montair 4mg 15 tablets the revised PTR was Rs. 143.79, while the PTR as per the calculation made by the NPPA for price fixation was Rs. 130.71. The revised prices, as per the argument of the company, has been considered in the price revision post review order, now.
In its argument with the review authority earlier, NPPA submitted that both the drug formulations have been added in NLEM,2022 for the first time and consequently added into the Schedule I of the Drugs Prices Control Order (DPCO), 2013, Form V filed till July 31, 2022 have been considered. During the time of price fixation, the July, 2022 database was being used for ceiling price fixation, said the Authority.
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