New Delhi : The National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of 111 scheduled formulations and fixed the ceiling price of 17 new ones in its latest Authority meeting as part of fixing the prices of the formulations listed in the National List of Essential Medicines (NLEM), 2022, which has been amended as the new Schedule I of the Drugs (Prices Control) Order, 2013 recently.
The Authority meeting, held on January 11, considered the 134 formulations for which the draft calculation sheet of ceiling prices were uploaded in the NPPA website from December 13 to 23, 2022. The drug price regulator has invited comments from the stakeholders within 10 working days on the draft calculation sheets and the period for representations on the formulations uploaded on December 23 ended on January 6, 2023.
Ceiling price on three of the formulations uploaded on December 13, was fixed in the previous meeting held on December 30, 2022. Fixing of another three formulations were deferred as the calculation sheets needed re-upload. The Authority has fixed the price of 128 formulations, including fixing the ceiling price of 17 new formulations and revising the prices of 111 formulations that were existing in the previous Schedule I.
The NPPA received 693 representations from the companies till January 6, 2023, within the prescribed time lines of 10 days. The companies have submitted copies of invoices showing the revised Price to Retailer (PTR) and snapshots of sample packs showing revised Maximum Retail Price (MRP).
The Authority meeting observed that the representations were broadly related to the issues in data in worksheets and those related to methodology, which was deliberated and finalised in the previous meeting of the Authority.
Based on the representations on the data, the Authority revised the prices of 71 formulations compared to the ceiling prices reflected in the draft uploaded working sheets, before approving the ceiling prices of all the 128 formulations.
The ceiling prices fixed in the latest meeting include certains dosage and strengths of Levothyroxine, Ondansteron, Clindamycin, Prednisolone, Zoledronic acid, Adenosine,Ciprofloxacin, Isoflurane, Cytosinearabinoside, Metronidazole, Amiodarone, Tenecteplase, Bendamustinehydrochloride, combination of Lopinavir and Ritonavir, combination of Artemether and Lumefantrine, among others.
It may be noted that in two previous meetings the Authority has fixed or revised the ceiling prices of 119 and 97 scheduled formulations, respectively, after providing time for the stakeholders to submit their representations and revising ceiling prices of some of the formulations based on those representations.
The Authority meeting held on January 11, 2023 has also fixed the retail price of 12 formulations under the DPCO, 2013, including revision of the retail price of Pantoprazole 20 mg tablets manufactured by Pure and Cure Healthcare and marketed by Torrent Pharmaceuticals Ltd based on the company representation. The Authority has earlier fixed the retail price of the tablet as 0.75 per tablet based on Torrent’s claim in its application for a retail price of Rs 7.50 per 10 tablets excluding taxes.
However, the company informed the price regulator that due to typo error, it has erroneosly mentioned retail price excluding taxes claimed for approval or Rs 7.50 per 10 tablets, in the price of Rs 7.50 per one tablet excluding taxes. The Authority deliberated on the matter and noted that the PTR of other company brands with more than one per cent market share are in the range of Rs 2.84 per tablet to Rs 8.27 per tablet and the average PTR is Rs 5.76 per tablet. Based on this, the Authority approved the retail price of Rs 6.68 per tablet excluding taxes.