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The Department of Pharmaceuticals (DoP) has upheld the drug price regulator's action of fixing ceiling price of antiviral drug acyclovir 800 mg per tablet, rejecting a review application filed by Cipla Ltd.
The company, which has its brand Acivir 800 mg tablet DT 5's in its product basket, approached the review authority against National Pharmaceutical Pricing Authority's (NPPA) order on January 11, 2023 fixing the ceiling price of the drug.
The company argued that its brand was included in the revised Schedule I of the Drugs Prices Control Order (DPCO), 2013 notified on November 11, 2022 and the draft calculation of ceiling price was issued based on this.
In spite of representation filed against the draft ceiling price with all relevant documents proving that the company has duly implemented the 10 per cent revision in maximum retail price based on the DPCO, the NPPA considered the old Price to Retailer (PTR) for ceiling price fixation.
It argued that the ceiling price calculation of acyclovir 800 mg per tablet should have included the revised PTR for Acivir 800 mg tablet DT 5's at Rs. 175.88 and not Rs. 159.89. It maintained that the manufacturers reserve the right to increase the MRP of non-scheduled formulations by 10 per cent once in a year and thus, an increase in PTR post July, 2022 should also be considered in the calculation of ceiling prices of the scheduled formulation.
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, it added.
Besides, it pointed out that the 105th authority meeting of NPPA in December 15, 2022, that the price revision in draft calculation of ceiling prices should be uploaded by NPPA for 10 working days for comments and if no comments are received or the issues are addressed, the same shall be placed before the Authority for decision. In these cases, where the data has been verified and confirmed by Pharmarac, prices will be re-computed based on revised data. However, the NPPA did not upload the revised working sheet despite its representation, and the correction was not made later also, it added.
NPPA argued that the authority, while earlier decided to consider the prices in the month of April, 2022, later decided to take the data of July, 2022, considering the time lag with which price changes carried out due to revision of Wholesale Price Index is reflected by the data.
The formulation was non-scheduled before NLEM, 2022 and the form II submission is not applicable in this case. The company submitted Form V with NPPA in the revised PTR at Rs. 175.88 on August, 2022, but the PTR for July, 2022 at Rs. 159.89 was reflected in Pharmarack database, based on Form V filed on March 3, 2022.
Further, the decision for publishing the revised draft calculation sheet for 10 days, as per the 105th authority meeting, is applicable only in the case of Suo Moto corrections in the notified prices, it argued.
The review authority accepted the arguments and logics given by NPPA that the price data of July, 2022 was used for fixing the ceiling price based on its earlier decision and the decision in the 105th meeting was only in the context of Suo Moto corrections.
Based on this, the order issued by Awadhesh Kumar Choudhary, senior economic adviser, DoP, concluded, "The action of NPPA fixing the ceiling prices of subject formulation is upheld and the review application under consideration is accordingly rejected."
It may be noted that the review authority has rejected several review applications filed by companies for review of price orders on the ceiling prices of various scheduled formulations, while allowing a few of review applications in the month of October and November, this year.
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