The Pharmaceuticals Department has confirmed the decision of the nation’s drug price regulator to set a maximum price for the antiviral medication acyclovir 800 mg per tablet, dismissing an appeal from Cipla Ltd.
Cipla, whose portfolio includes the Acivir 800 mg tablet DT 5’s, contested the National Pharmaceutical Pricing Authority’s (NPPA) January 11, 2023 directive that established a price cap for the drug.
The company contended that its brand was incorporated into the amended Schedule I of the Drugs Prices Control Order (DPCO) of 2013, which was announced on November 11, 2022, and the preliminary price ceiling calculations were based on this update.
Despite submitting documentation in opposition to the proposed price ceiling—demonstrating adherence to a 10% retail price revision in line with the DPCO—the NPPA used previous Price to Retailer (PTR) data for setting the price ceiling.
Cipla argued that the ceiling price calculation for acyclovir 800 mg should have involved the updated PTR of Rs. 175.88 instead of Rs. 159.89 for the Acivir 800 mg tablet DT 5’s. The company asserted that manufacturers are entitled to increase the maximum retail price of non-scheduled formulations by 10% annually, thus post-July 2022 PTR increases should have factored into the pricing of the scheduled formulation.
They emphasized that the market-based data’s lack of PTR visibility should not imply non-compliance with the revised MRP when documented proof, such as sales invoices and pack shots with the updated MRP, was available.
Additionally, Cipla highlighted the NPPA’s 105th authority meeting on December 15, 2022, where it was suggested that draft revision calculations be publicly available for 10 working days for feedback. If no comments were received or issues were addressed, the decisions were to be presented to the Authority. In verified cases, prices would be recalculated using adjusted data, but the NPPA allegedly failed to publish the revised data or make subsequent corrections.
The NPPA contended that, initially intending to use April 2022 prices, they switched to July 2022 data, acknowledging a data lag reflecting price shifts due to Wholesale Price Index adjustments.
As the formulation was non-scheduled prior to NLEM 2022, the form II submission was deemed irrelevant. Cipla submitted Form V to NPPA indicating a revised PTR of Rs. 175.88 in August 2022, but Pharmarack’s database showed July 2022’s Rs. 159.89 PTR, based on a March 3, 2022 Form V submission.
The NPPA clarified that the 10-day exposure of revised calculations applied only to Suo Moto corrections in notified prices.
The review authority supported NPPA’s decision-making logic and their utilization of July 2022 data given past deliberations, noting that the 105th meeting directive concerned only Suo Moto changes.
Awadhesh Kumar Choudhary, senior economic adviser at DoP, decreed, “The NPPA’s action of setting ceiling prices for the specified formulation is upheld, leading to the rejection of the review application.”
It should be noted that the review authority has turned down several review petitions from companies concerning ceiling price decisions on different scheduled formulations, approving a few applications in October and November of this year.