NPPA panel fixes retail price of Sun Pharma Cyclosporine, Details

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) panel has fixed the retail price of each mL of solution containing Cyclosporine IP 0.9 mg, manufactured and marketed by Sun Pharmaceutical Industries.

The retail price of each ml solution containing Cyclosporine IP 0.9 mg per ml in a 0.25 ml pack for Sun Pharmaceutical Industries. (manufacturer and marketer) has been set at Rs. 51.29 per 0.25 ml pack, excluding GST .

This recommendation came during the 37th meeting of the Multidisciplinary Committee of Experts held on November 25, 2021, where the issue of retail price fixation of each ml solution containing Cyclosporine IP 0.9 mg for Sun Pharmaceutical Industries (manufacturer and marketer) under Para 5 of the DPCO, 2013 was deliberated.

Cyclosporine is a steroid-sparing immunosuppressant used in organ and bone marrow transplants as well as for inflammatory conditions such as ulcerative colitis, rheumatoid arthritis, and atopic dermatitis.

At a recent Multidisciplinary Committee of Experts meeting, the panel noted that the new drug for which an application for retail price has been filed by Sun Pharmaceutical Industries is a single use pack, whereas, while recommending the price earlier in its 36th meeting dated 11.10.2021, the data for both single-use and multi-use products was considered.

Further, the Committee deliberated upon the matter in detail and is of the view that single-use vials are used only once and do not contain preservatives. 

After detailed deliberation, the Committee decided to calculate the retail by considering only the data of a single-use pack. 

Accordingly, the Committee recommended the retail price of each ml solution containing Cyclosporine IP 0.9 mg per ml in a 0.25 ml pack for Mls Sun Pharmaceutical Industries Ltd. (manufacturer and marketer) at Rs. 51.29 per 0.25 ml pack excluding GST as detailed below:

a. Calculation of retail Price of Cyclosporine IP 0.05% w/v drops based on Pharmatrac data for the month of February 2021 (by considering only single use pack) = Rs. 131.52 per ml

b. Derived Retail price for Cyclosporine IP 0.9 mg/ ml based on the recommendation of Pronab Sen Committee Report with respect to calculated retail price of Cyclosporine IP 0.05% w/v drops

P(s) = P*.[1+a.{(s-s*)/s")]

Where : P(s) = Price ceiling of the strength s

P* = price ceiling for reference strength s" s = strength in terms of API content

• s* = reference strength

= 131.52[1+0.70(0.9-0.5)/0.5}] = Rs. 205.17 per ml

c. Therefore, the retail price of Cyclosporine solution.'4.9 mg/ml in 0.25 ml pack= Rs.205.17x0.25= Rs.51.29 (excluding GST)

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