The National Pharmaceutical Pricing Authority (NPPA) has sought manufacturers and marketing companies of iohexol injection 300 mg iodine per ML, a diagnostic agent, to submit price and market data on the product for fixation of its ceiling price. The move follows a review order from the Department of Pharmaceuticals (DoP) directing the price regulator to fix the ceiling price of the formulation as a special case.
All the concerned manufacturers and marketing companies of iohexol injection 300 mg iodine per ML are requested to furnish the Price to Retailer (PTR) and Moving Annual Turnover (MAT) in value terms for the month of July, 2022 in a format provided by the Authority, along with Form II or V filed to NPPA.
"The information may be furnished positively within 7 days from the issue of this OM (office memorandum) for taking appropriate action for fixation of ceiling prices pursuant to the issue of Revised Schedule-I of DPCO, 2013," it added.
The information may be furnished within the stipulated period so that the ceiling prices are fixed in a transparent manner, it averred.
The DoP has referred the matter of fixation of ceiling price for diagnostic agent formulations containing iohexol injection 300 mg iodine/ml back to the Authority, in an order in favour of a review application filed by Mumbai-based JB Chemicals and Pharmaceuticals, and Unijules Life Sciences Ltd.
JB Chemicals approached the review authority under the Department in April, 2023, against price fixation order of NPPA, issued in March 31, 2023 fixing the ceiling price of Contrapaque 300 mg infusion 100 ml and Contrapaque 30 mg injection 20 ml containing iohexol injection 300 mg iodine/ml, alleging that the authority has erred in determining the ceiling price.
The formulations were included in the Schedule I of the Drugs Prices Control Order (DPCO), 2013, revised on November 11, 2022.
Iohexol, a radiographic contrast agent, is not used as a medicine, but rather as a contrast media in clinics and diagnostic centres for procedures like angiograms.
The company said that as such, its supply chain differs from the retail sale channels typically used for pharmaceuticals. While Pharmatrac, the agency which provides data to the NPPA related to pricing, is designed to capture secondary sales data for the retail sale of pharmaceuticals, it is not equipped to track secondary sales of medical devices or contrast media.
It alleged that the authority has fixed the ceiling price for the product based on only one company - Contrapaque brand f JB Chemicals - as appearing in the Pharmatrac database, while there are products from Ocean Pharmaceuticals, Arco Lifesciences, Genetek Life Sciences, GE Healthcare and Unijules Life Sciences, which are not considered by NPPA for price fixation.
Unijules, which manufactures Nioscan 300 and Nioscan 350 brands, approached the review authority alleging that six companies are manufacturing the formulation in several brands and the reduction as per the monopoly conditions is beyond the scope of the DPCO, 2013.
In response to JB Chemicals' argument, NPPA informed the review authority that iohexol injection was covered under National List of Essential Medicine (NLEM), 2015 too as iohexol Injection 140 to 350 mg iodine per ml and ceiling price was fixed at Rs. 15.08 per ml for the formulation iohexol injection 300 mg iodine/ml on the basis of Pharmatrac database, based on one manufacturer. This was further revised annually as per wholesale Price Index (WPI) and the latest ceiling prices under the NLEM, 2015, effective from April 1, 2022 was Rs. 18.46 per ml. The ceiling price for no other strength of the drug was fixed under NLEM, 2015.
The iohexol injection 140 to 350 mg iodine per ml continued under NLEM, 2022 and based on market data from Pharmatrac, iohexol injection is available in two strengths, in 300 mg iodine/ml and 350 mg iodine/ml. The draft worksheets for these formulations were uploaded in February, 2023 for 10 working days to invite comments. However, no company filed representation against the draft worksheet, it said.
The ceiling price was fixed following this, on March 31, 2023, the price was notified at Rs. 15.07 for 300 mg iodine/ml and Rs. 12.70 for 350 mg iodine/ml. These prices were further revised to Rs. 16.89 for 300 mg and Rs. 14.23 for 350 mg, respectively, as per the WPI increase effective from April 1, 2023.
The review authority, examining arguments from both the sides, noted that the company gave evidence to the effect that the sales value captured by Pharmatrac was significantly lower than their total sales volume and that multiple companies in the market are selling brands containing these diagnostic agents.
"The claim of the applicant cannot be denied. Therefore, as a special case of drug being mainly sold to diagnostic centres and hospital, NPPA may utilise the powers given to it under paras 9(1) and 9(7) of DPCO, 2013 to explore other database to capture the representative market for ceiling price fixation in the present case," said Awadhesh Kumar Choudhary, senior economic adviser to the Government of India.
In this backdrop, the authority referred back the case of ceiling price fixation to NPPA for examination as per the extant provisions of DPCO, 2013.
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