NPPA Fixes Ceiling Price Of 31 Scheduled Formulations Under Revised Schedule I

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling price of 31 formulations under the revised Schedule I of the Drugs (Prices Control) Order, 2013. It has also deferred the ceiling price fixation of four scheduled formulations for multiple reasons.

The formulations for which the ceiling prices were fixed in its recent meeting includes anti-HIV combination medicines darunavir 600mg + ritonavir 100 mg and tenofovir disproxil fumarate 300mg + lamivudine 300 mg + dolutegravir 50 mg, nicotine 2 mg and 4 mg oral dosage forms for nicotine replacement therapy, oral contraceptive pill levonorgestrel 1.5 mg tablet, dietary supplement cholecalciferol solid oral dosage form 1000 IU sachet or granules or powder, all new formulations under the revised Schedule I of the DPCO, 2013, which has the drugs under the National List of Essential Medicines (NLEM), 2022.

The other formulations for which the ceiling prices were fixed include zidovudine 300 mg tablets, folic acid 5 mg capsule, fentanyl 50 mcg/ml injection, benzathine benxylpenicillin powder for injection, hyoscine butylbromide injection 20 mg/ml, omeprazole 40 mg capsules, desferrioxamine powder for injection, snake venom anti-serum, melphalan 2 mg, and 5 mg tablets, budesonide inhalation (MDI) 100 mcg/dose, 200 mcg/dose, and budesonide inhalation (DPI) 200 mcg/dose, among others.

It has deferred the ceiling price fixation of cancer drug imatinib capsule 400 mg and antimicrobial drug rifampicin 300 mg tablet since the single company appearing in the worksheet represented that the formulation is tablet in the case of imatinib and the formulation is capsule in the case of rifampicin. Hence, there was no item left to be considered for price fixation, it added.

The price of imatinib capsule was proposed to be Rs. 91.46 as against Rs. 317.99 while for rifampicin, the price was proposed at Rs. 3.64 as against Rs. 3.66, pointed out the Authority.

For budesonide 200 mcg and formoterol inhalation (MDI) 6 mcg and budesonide 400 mcg and formoterol 6 mcg, the prices proposed at Rs. 2.87, and Rs. 3.80, respectively. The drug price regulator said that it has received representations related to these combinations and investigation is on.

The Authority has uploaded the draft ceiling prices of 35 formulations based on the approved methodology on February 5, 2024 based on the database of October, 2023, for 10 working days to invite comments from the stakeholders.

The Authority has fixed the ceiling price of 700 formulations under the NLEM 2022 based on the methodology for fixation of ceiling price of scheduled formulations under the revised Scheduled formulations in the previous meetings held in November 2022, March, 2023 and May 1, 2023. The Authority, in January 2024, decided to use the October 2023 database and the month of October, 2023.

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