NPPA to Re-Examine Iohexol Injection Price Challenged by JB Chemicals

This decision stems from a review application filed by JB Chemicals under Para 31 of the Drugs (Prices Control) Order, 2013, contesting the price fixation order issued by NPPA on 31.03.2023.

The NPPA’s original order set ceiling prices for "Contrapaque 300mg infusion 100ml" and "Contrapaque 300mg injection 20ml," both containing Iohexol Injection 300mg iodine/ml. JB Chemicals argued that the NPPA erred in determining the ceiling price and requested a revision, highlighting that the unique nature of Iohexol as a diagnostic agent was not adequately considered.

Iohexol, a diagnostic contrast medium used in medical procedures like angiograms, is not distributed through typical retail pharmaceutical channels. Its supply chain primarily caters to clinics and diagnostic centers, making it distinct from conventional medicines. JB Chemicals contended that Pharmatrac, the database used by NPPA to determine prices, is designed for tracking retail pharmaceutical sales and does not account for medical devices or diagnostic agents like Iohexol.

Furthermore, JB Chemicals pointed out that other companies manufacture and sell formulations containing "Iohexol Injection 300mg iodine/ml," but NPPA based its price fixation on data from only one manufacturer—the Contrapaque brand by JB Chemicals. The following brands and companies were excluded from the NPPA’s calculation:

Brand Name		Company Name
Hexoimage 300-50 ml		Ocean Pharmaceuticals
Parnmage 300 -50 ml		Arco Lifesciences (I) Pvt Ltd
	Optiscan 300 - 50 ml		Genetek Lifesciences Pvt Ltd
	Optiscan 350-90 ml		Genetek Lifesciences Pvt Ltd
	Optiscan 300-100 ml		Genetek Lifesciences Pvt Ltd
	Omnipaque 300 -100 ml		GE Healthcare
	ioscan 300- 20 ml		Uni •ules Life Sciences Ltd
	Nioscan 300- 50 ml		Unijules Life Sciences Ltd
	Nioscan 300- 100 ml		Unijules Life Sciences Ltd
	Nioscan 300- 500 ml		Unijules Life Sciences Ltd

Due to the presence of other market players, JB Chemicals asserted that the reduction in price, as calculated under Monopoly Conditions in Para 6(1) of the DPCO 2013, was unjustified. They urged NPPA to leverage its authority under Paras 9(1) and 9(7) of the DPCO 2013 to gather representative data beyond the Pharmatrac database for a more accurate price calculation.

In response, NPPA clarified that Iohexol Injection had been included under the National List of Essential Medicines (NLEM) since 2015. Ceiling prices were initially fixed in 2017 based on Pharmatrac data, with periodic revisions according to the Wholesale Price Index (WPI). Iohexol Injection remained on the NLEM 2022 list, with ceiling prices for two strengths—300mg iodine/ml and 350mg iodine/ml—calculated and approved in March 2023.

While defending its methodology, NPPA acknowledged that Pharmatrac data primarily captures retail pharmaceutical sales and may not reflect the true market dynamics of diagnostic agents like Iohexol. The Department of Pharmaceuticals noted this limitation and recognized the applicant's evidence that Pharmatrac data significantly understated the market size and sales volume for Iohexol formulations.

Examining the issue, DoP noted that NPPA followed the set procedure for ceiling price fixation as used for all other formulations and used the market based data as available in the Pharmatrac. The draft worksheet was also uploaded on website to invite comments. However, no company filed any representation against the draft worksheet uploaded.

The Department further observed that;

“JB Chemicals has claimed that Iohexol is not used as a medication, but as a contrast medium in medical procedures such as angiograms at clinics and diagnostic centers. As a result, its supply chain differs from the typical retail distribution channels for pharmaceuticals. While Pharmatrac is designed to capture secondary sales data for retail pharmaceuticals, it is not equipped to track secondary sales of medical devices or contrast media. In this context, the Applicant also gave evidence to the effect that the sales value captured by Pharmatrack was significantly lower than their total sales volume and that multiple companies in the market are selling brands containing "Iohexol Injection 300mg Iodine/ml".”

“The claim of the applicant cannot be denied. Therefore, as a special case of drug being mainly sold to diagnostic centres and hospitals, NPPA may utilize 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.”

In light of these findings, the DoP referred the matter back to NPPA for re-examination as per the extant provisions of the DPCO 2013. It noted;

“In the backdrop of above, the case of Ceiling Price of "Iohexol injection 300mg iodine/ml" is being referred back to NPPA for examination as per the extant provisions of DPCO, 2013.”