NPPA panel fixes MRP of Ajanta Pharma Metoprolol Tartrate, lvabradine Hydrochloride FDC
New Delhi: The National Pharmaceutical Pricing Authority (NPPA) panel has fixed the price of the Fixed Dose Combination (FDC) of each film coated tablet containing Metoprolol Tartrate IP 25 mg plus lvabradine Hydrochloride eq. to lvabradine 5 mg manufactured and marketed by Ajanta Pharma.
The retail price of each film coated tablet containing Metoprolol Tartrate and lvabradine Hydrochloride eq. to lvabradine has been fixed at two different strengths of Metoprolol Tartrate, which include,
• The retail price of each film-coated tablet containing Metoprolol Tartrate IP 25 mg plus lvabradine Hydrochloride equivalent to lvabradine 5 mg is Rs. 15.46 (excluding GST).
• The retail price of each film-coated tablet containing Metoprolol Tartrate IP 50 mg plus lvabradine Hydrochloride equivalent to lvabradine 5 mg is Rs. 17.74, excluding GST.
This recommendation came during the 36th meeting of the Multidisciplinary Committee of Experts held on 11.10.2021 where the issue of retail price fixation of each film coated tablet containing Metoprolol Tartrate and lvabradine Hydrochloride eq. to lvabradine for Ajanta Pharma (manufacturer and marketer) under Para 5 of the DPCO, 2013 was deliberated.
The above mentioned combination drug containing Metoprolol Tartrate and Ivabradine Hydrochloride is used in the treatment of Angina (heart-related chest pain). The combination acts by lowering the heart rate and increasing the efficiency with which the heart pumps blood throughout the body.
Metoprolol is a beta-blocker used in the treatment of hypertension and angina, and used to reduce mortality due to myocardial infarction.
Ivabradine is a novel heart rate lowering medicine for the symptomatic management of stable angina pectoralis and symptomatic chronic heart failure. It is a Hyperpolarization-Activated Cyclic Nucleotide (HCN) channel blocker used to reduce the risk of hospitalisation for worsening heart failure in adult patients
At a recent Multidisciplinary Committee of Experts meeting, the panel noted that Ajanta Pharma Ltd had manufactured and marketed both the above mentioned formulations containing Metoprolol Tartrate plus lvabradine Hydrochloride without obtaining prior price approval, which is in contravention of the provisions of DPCO 2013.
The Committee further noted from the Pharmatrac Database that M/s Ajanta Pharma Ltd had launched both formulations since November 2017.
In light of the foregoing, after detailed deliberation, the Committee deliberated upon the matter in detail and recommended the retail price for both the above mentioned formulations based on the data available for the month of April 2017, i.e., six months prior to the launch of the formulation by Ajanta Pharma.
Accordingly, the Committee recommended the retail price of each film coated tablet containing Metoprolol Tartrate IP 25 mg plus lvabradine Hydrochloride eq. to lvabradine 5 mg for Ajanta Pharma (manufacturer and marketer) at Rs. 15.46 per tablet excluding GST as detailed below:
| Computation of Retail Price per Tablet | Source/Method | Amount (Rs.) |
| Composition - Each film coated tablet containing Metoprolol Tartrate IP 25 mg + lvabradine Hydrochloride eq. to lvabradine 5 mg |
|
|
| a. Metoprolol Tartra te IP 25 mg | Ceiling Price (as per notification no .1039(E) dated 01st April, 2017) | 2.94 |
| b. lvabradine Hydrochloride eq. lvabradine5 mg | Retail price (as per April, 2017 data) | 14.18 |
| Worked out Retail Price |
| 17.12 |
| c. Less 20% of the lowest of (a) and (b) as recommended in the Pronab Sen Committee report |
| 0.59 |
| Net Retail Price (a+b-c) |
| 16.53 |
| Company Claimed Price |
| 15.46 |
| Recommended price |
| 15.46 |
Similarly, the Committee recommended the retail price of each film coated tablet containing Metoprolol Tartrate IP 50 mg plus lvabradine Hydrochloride eq. to lvabradine 5 mg for Ajanta Pharma (manufacturer and marketer) at Rs. 17.74 per tablet excluding GST as detailed below:
| Computation of Retail Price per Tablet | Source/Method | Amount (Rs.) |
| Composition - Each film coated tablet containing Metoprolol Tartrate IP 50 mg + lvabradine Hydrochloride eq. to lvabradine 5 mg |
|
|
| a. Metoprolol Tartra te IP 50 mg | Ceiling Price (as per notification no .1039(E) dated 01st April, 2017) | 4,45 |
| b. lvabradine Hydrochloride eq. lvabradine5 mg | Retail price (as per April, 2017 data) | 14.18 |
| Worked out Retail Price |
| 18.63 |
| c. Less 20% of the lowest of (a) and (b) as recommended in the Pronab Sen Committee report |
| 0.89 |
| Net Retail Price (a+b-c) |
| 17.74 |
| Company Claimed Price |
| 17.81 |
| Recommended price |
| 17.74 |
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