NPPA Committee Caps Price of Akums' Cetirizine Eye Drops at Rs 14.42 per ml
New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of Cetirizine Hydrochloride IP eq. to Cetirizine 0.24 % w/v plus Benzalkonium Chloride Solution IP 0.02 % v/v (as preservative) ophthalmic eye drops at Rs 14.42 per ml for a 5 ml pack for products manufactured by Akums Drugs & Pharmaceuticals and marketed by Dr. Reddy's Laboratories and Mankind Pharma, following recommendations of its Multidisciplinary Committee of Experts (MDC).
The matter was deliberated during the 73rd meeting of the Multidisciplinary Committee of Experts (MDC) held on 25 November 2025, wherein the Committee examined retail price fixation of each ml Contains: Cetirizine Hydrochloride IP eq. to Cetirizine 0.24 % w/v + Benzalkonium Chloride Solution IP 0.02 % v/v (as preservative) for: (i) Akums Drugs & Pharmaceuticals Ltd. (Manufacturer) and Dr. Reddy’s Laboratories Ltd. (Marketer) (F.No. 4864); and (ii) M/s Akums Drugs & Pharmaceuticals Ltd. (Manufacturer) & M/s Mankind Pharma Ltd. (Marketer) (F. No. 4938)
The applicants have filed the application for retail price fixation of each ml containing Cetirizine Hydrochloride IP Eq. to Cetirizine 0.24% w/v Benzalkonium Chloride Solution IP 0.02% v/v (As preservative) Eye Drops (Pack size-5ml). The data for the subject formulation was not available in the Pharmarack database.
Therefore, the matter was placed for the deliberations of the Multidisciplinary Committee of Experts (MDC) in its 73rd meeting held on 25.11.2025, wherein the Committee directed to explore details of other antihistamine eye drops.
In view of the deliberations, in the 73rd meeting of the MDC, the market-based data as available with NPPA was examined. It was observed that eye drops containing formulations of Azelastine, Epinastine and Olopatadine, which are also second-generation antihistamine like Cetirizine, are available in the market. (Source: WAO Journal, September 2008).
The Committee noted that tablet forms of Cetirizine as well as of the above formulations are available in the market. However, there is substantial price difference among the prices of these tablets.
Therefore, the Committee opined that these Ophthalmic eye drops are not comparable with the eye drop of Cetirizine.
The Committee observed that the process for manufacturing eye drops is different than the manufacturing process of tablets and additional steps are involved in converting API to Ophthalmic formulations with respect to sterility, stability, irritability, etc., which makes Ophthalmic formulations more expensive than the Tablet formulation.
In order to understand the trend of the price differential, the Committee examined the data in respect of 3 scheduled and 2 non-scheduled formulations which are available both in tablet as well as eye drop form.
Based on the analysis of the said data, the Committee observed that the average ratio of Eye drops to Tablets of same strength of Moxifloxacin, Ciprofloxacin, Prednisolone, Chloramphenicol and Ketorolac works out to 32.47.
In view of the above analysis, the Committee decided to apply said average ratio to the price of Cetirizine tablet to arrive at the price of Cetirizine eye drops. Accordingly, the retail price is worked out as below:
Calculation | |
Applied formulation: Each ml containing Cetirizine Hydrochloride IP Eq. to Cetirizine 0.24% or 240 mg in 100ml; Pack size is 5 ml containing 12mg | |
A. Derived price of Cetirizine Tablet 12mg (Note 1) | Rs.2.22 |
B. Ratio of eye drops to Tablets of same strength of other formulation | 32.47 times |
C. Worked out price of Cetirizine 0.24% w/v eye drop (pack of 5 ml containing 12mg of Cetirizine) (AXB) | Rs.72.08/pack of 5 ml i.e. Rs.14.42/ml |
D. Claimed Price per pack of 5 ml (i) M/s Akums Drugs & Pharmaceuticals Ltd. (Manufacturer) & M/s Dr. Reddy’s Laboratories Ltd. (Marketer); | (i) Rs.30 per ML |
(ii) M/s Akums Drugs & Pharmaceuticals Ltd. (Manufacturer) & M/s Mankind Pharma Ltd. (Marketer) | (ii) Rs.55 per ML |
E. Recommended retail price (Lower of worked out and claimed price | Rs.14.42 per ML for both applications |
Note-1:
(i) The retail price of Cetirizine Tablet 12mg based on formula recommended in the Pronab Sen
Committee report is as below:
Ceiling price of Cetirizine Tablet 10mg is Rs. 1.91 per tablet.
Derived retail price as per recommendation of Pronab Sen Committee:
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
A= 0.8 for tablet / capsule and 0.7 for injectables.
=1.91 [1+0.8{(12-10)/10}]
=Rs. 2.22 per tablet (excluding GST)
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