New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has notified revised ceiling prices of four scheduled drugs, with an upward revision, following review orders passed by the Department of Pharmaceuticals (DoP).
The ceiling price of antiviral drug valganciclovir 450 mg has been revised from Rs. 400.73 per tablet to Rs. 408.27 per tablet, while the price of blood pressure drug metoprolol 25 mg has been revised to Rs. 4.25 per tablet compared to Rs. 4.20 per tablet.
Similarly, ceiling price of antiretroviral medicine lamivudine 100 mg has been revised to Rs. 11.07 per tablet as compared to Rs. 10.40 per tablet. Price of anti-asthma drug montelukast 4 mg has been revised to Rs. 10.23 per tablet as compared to Rs. 10.03 per tablet, fixed earlier. The prices have been revised following DoP’s favourable orders in review applications filed by RPG Life Sciences and Cipla Ltd.
The prices have been calculated after giving effect of Wholesale Price Index (WPI) increase of 12.1218 per cent with effect from April 1, 2023 and WPI increase of 0.00551 per cent with effect from April 1, 2024.
The Authority released the draft calculation sheets with revised ceiling prices on its website and invited stakeholders to comment. No representations were received for the revised draft prices of valganciclovir and metoprolol, for which the review application was filed by RPG Life Sciences earlier.
In case of metoprolol 25 mg, Cipla Ltd filed a representation stating that the price of the non-scheduled formulation metoprolol ER 25 mg tablets has been considered in the working sheet. The Authority noted that in revised Schedule I with National List of Essential Medicines (NLEM) 2022, metoprolol is listed as metoprolol tablet 25 mg and its modified release, extended release and sustained release variants are not mentioned separately.
It said that accordingly, the ceiling price is calculated based on methodology approved in this respect of its meeting held on November 23, 2022, by considering all variants. It also noted that the methodology is in line with practice as followed by NPPA under NLEM 2015 and 2022.
RPG Life Sciences filed review application with the DoP 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.
The company 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. Both the drugs were included in the Schedule I of the Drugs Prices Control Order (DPCO) with effect from November 11, 2022, with the amendment of the Schedule in line with the National List of Essential Medicines (NLEM), 2022.
It added that as per the 105th Authority Committee meeting on December 15, 2022, the NPPA need to upload the corrected worksheet in the website for 10 working days for comments, if any and in case of non-receipt of any comments or after addressing any issues received on the revised working sheets, the same shall be placed before the Authority for decision. In those cases where the data has been verified and confirmed by Pharmatrac, the data agency, prices will be re-computed based on revised data.
This was not adhered to by the NPPA and therefore, the ceiling price fixation of Cmvee 450 mg tab 2’s on December 19, 2022 and Cardibeta XR tab 25 mg 10’s on January 6, 2023 should not have been notified without providing manufacturers another opportunity to review the revision in draft calculation of ceiling prices, it argued.
The review authority accepted the contention regarding inaccurate fixation of price of the two formulations raised by the company and referred the cases back to the NPPA for recalculation of the prices as per the extant provisions of DPCO, 2013.
DoP has also referred the matters related to price fixation of montelukast and lamivudine in petitions filed by Cipla Ltd, observing that the Authority did not consider the Form V submitted by Cipla in March and May, 2022, before finalising the ceiling prices.
Cipla field a review application 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.
The company alleged that the NPPA did not consider the revised Price to Retailer (PTR) of these drugs, even though the company presented documents including representation letter, Form-V, invoice and pack shot within the prescribed timelines of 10 working days against the draft working sheet of the ceiling price issued on November 25, 2022.
Examining the arguments, the review authority observed that during the hearing, NPPA acknowledged that inadvertently, Form V of the Applicant was not considered while taking the PTR of eligible brands for fixing the ceiling price for the formulations and therefore the ceiling price for these formulation require recalculation based on revised PTR.
