NPPA panel suggests retail price of Ondansetron, Rabeprazole FDC marketed by Alkem
New Delhi: The National Pharmaceutical Pricing Authority (NPPA) Committee has suggested the retail price of each enteric coated tablet containing Rabeprazole Sodium IP 20 mg and Ondansetron Hydrochloride IP eq. to Ondansetron 4 mg, manufactured by Dallas Drugs and marketed by Alkem Laboratories, at Rs. 10.00 per tablet excluding GST.
The Ondansetron and Rabeprazole combination drug is used to treat nausea, vomiting, gastroesophageal reflux disease (Acid reflux) and peptic ulcer disease.
The recommendation has been made by the Multidisciplinary Committee of Experts at its 34th meeting of the "Multidisciplinary Committee of Experts", held on 26.07.2021 under the convenorship of Sh. N.I. Chowdhury, Adviser (Cost), NPPA.
The issue of the retail price fixation of each enteric coated tablet containing Rabeprazole Sodium IP 20 mg and Ondansetron Hydrochloride IP eq. to Ondansetron 4 mg for M/s Dallas Drugs Pvt. Ltd. (manufacturer) and Mis Alkem Laboratories Ltd. (marketer) was addressed during the meeting.
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Ondansetron is a carbazole derivative with antiemetic activity. It is a selective serotonin receptor antagonist that acts by competitively blocking the action of serotonin at 5HT3 receptors, resulting in suppression of chemotherapy-and radiotherapy-induced nausea and vomiting. On the other hand, Rebeprazole is a proton pump inhibitor (PPI) and a potent inhibitor of gastric acidity. It is used in the therapy of gastroesophageal reflux and peptic ulcer disease.
Regarding the fixed dose combination of Ondansetron and Rabeprazole, in the latest Multidisciplinary Committee meeting, the committee noted that the Fixed Dose Combination (FDC) of enteric coated tablet containing Rabeprazole Sodium IP 20 mg and Ondansetron Hydrochloride IP eq. to Ondansetron 4 mg is within the list of the formulations as per Central Drugs Standard Control Organisation (COSCO) letter dated 08.01.2020 regarding the 'Procedure to be followed for subsequent applicant in respect of FDCs declared as rational by Prof. Kokate Committee and approval by DCG(I).'
After detailed deliberation, the committee recommended the retail price of each enteric coated tablet containing Rabeprazole Sodium IP 20 mg and Ondansetron Hydrochloride IP eq. to Ondansetron 4 mg for Dallas Drugs Pvt. Ltd. (manufacturer) and Alkem Laboratories Ltd. (marketer) at Rs. 10.00 per tablet excluding GST as detailed below: -
Computation of Retail Price per Tablet | Source/Method | Amount (Rs.) |
Composition - Each enteric coated tab containing Rabeprazole Sodium IP 20 m! Ondansetron Hydrochloride IP eq. Ondansetron 4 mg | ||
a. Rabeprazole Sodium IP 20 mg | Retail price (as per November 2020 data) | 6.66 |
b. Ondansetron 4 mg | Ceiling Price (as per notification no.1330(E) dated 25.03.2021 | 4.72 |
Worked out Retail Price | 11.38 | |
c. Less 20% of the lowest of (a) and (b) as recommended in the Pronab Sen Committee report | 0.94 | |
Net Retail Price (a+b-c) | 10.44 | |
Company Claimed Price | 10.00 | |
Recommended price | Rs. 10.00 |
