NPPA panel fixes retail price of Sun Pharma Cyclosporine
New Delhi: The National Pharmaceutical Pricing Authority (NPPA) Committee has suggested 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 Ltd. (manufacturer and marketer) at Rs 35.57 per 0.25 ml pack, excluding GST .
This recommendation came during the 36th meeting of the Multidisciplinary Committee of Experts held on 11.10.2021 where the issue of the retail price fixation of each ml solution containing Cyclosporine IP 0.9 mg in 0.25 ml pack manufactured and marketed by Sun Pharmaceutical Industries 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 inflammatory conditions such as ulcerative colitis, rheumatoid arthritis, and atopic dermatitis.
Earlier, the Medical Dialogues Team had reported that drug major Sun Pharmaceutical Industries' one wholly-owned subsidiary had commercialised CEQUA (cyclosporine ophthalmic solution) 0.09% in the U.S., indicated for the treatment of dry eye disease.
Also Read: Sun Pharma To Develop, Commercialise Cyclosporine Eye Drops In Greater China
CEQUA, which offers the highest concentration of cyclosporine for ophthalmic use approved by the U.S. Food and Drug Administration (FDA), is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye), an inflammatory disease.
CEQUA (cyclosporine ophthalmic solution) 0.09% is a patented, novel, proprietary nanomicellar (NCELL) formulation of cyclosporine in a clear, preservative-free, aqueous solution.
CEQUA provides the highest FDA-approved concentration of cyclosporine for ophthalmic use and is the first and only approved cyclosporine treatment delivered with NCELL technology. The innovative NCELL formulation penetrates the aqueous layer of the tear film in the eye, then the nanomicelles break up to release cyclosporine to penetrate ocular tissues.
At a recent Multidisciplinary Committee of Experts meeting, after detailed deliberation, the committee recommended the retail price of each ml solution containing Cyclosporine IP 0.9 mg per ml in 0.25 ml pack for Sun Pharmaceutical Industries (manufacturer and marketer) at Rs. 35.57 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 = Rs. 91.20 per ml.
b. Derived retail price for Cyclosporine IP 0.9 mg/ml based on the Pronab Sen Committee Report recommendation in relation to the 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
= 91.20 [1+0.70{0.9-0.5)/0.5}] = Rs. 142.272 per ml
As a result, the retail price of Cyclosporine solution 0.9 mg/ml in a 0.25 ml pack equals Rs.142.272x0.25= Rs.35.57 (excluding GST).
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