The National Pharmaceutical Pricing Authority (NPPA) has directed Bayer Zydus Pharma, a part of German multinational pharma firm Bayer, to continue production and sales of various strengths and quantities of diagnostic agent Urografin for one more year as against the company’s application to discontinue the scheduled formulation.
The drug price regulator, in the recent Authority meeting, considered the request of the company to discontinue four scheduled formulations - Urografin 76% -20 ml, 50 ml, and 100 ml and Urografin 60%-20 ml containing meglumine diatrizoate, under Form IV as per the Drugs (Prices Control) Order (DPCO), 2013.
The Authority said that it has decided to re-invoke the directions issued under Paragraph 3 of the DPCO, to direct the company to continue production and sales of these formulations for a period of one year, that is up to February 28, 2027. Last year, the Authority had extended the restriction against discontinuation of the drug for one year, till the end of February, 2026.
The Authority, extending the order to continue production in 2024, had asked the company to ensure that the production is not reduced by more than 25 per cent of the production level at the time of discontinuation application. On January 11, 2023 directed the company to continue import or production and sale of these formulations till February 29, 2024.
The company approached the NPPA with its request for discontinuation of these formulations in August, 2021, due to economic unfeasibility and a clinical shift from High-Osmolar Contrast Media (HOCM) to Low-Osmolar Contrast Media (LOCM). The company also has Ultravist, a newer generation LOCM product, in its product portfolio.
The matter was examined in the Standing Committee meetings constituted to discuss discontinuation cases along with the public health experts and the inputs of the private diagnostic lab representatives were also sought.
"Based on the inputs from the stakeholders and recommendations of the Standing Committee, directions were issued by the Authority under Para 3 of the DPCO, 2013 from time to time and currently the same is in force till 28.2.2026," said the Authority in its meeting on February 27, 2026, while re-invoking the provisions.
NPPA also noted that the formulation is a hospital supply formulation, and as per the available market-based data, only a limited number of market players are present in the market.
The Authority also observed that the Central Drugs Standard Control Organisation (CDSCO) has informed it on February 6, that the application of the company for grant of registration certificate is pending at the company's end since August 26, 2025 for submission of response of query raised by the Drugs Controller General (India) with regard to its new drug permission.
During the latest meeting of the Authority, the CDSCO also clarified that the company should submit the earlier manufacturing permission or licence issued in respect of the formulation, for consideration by the CDSCO.
The Para 3 of DPCO, 2013 comprise directions to manufacturers of active pharmaceutical ingredients (API) or bulk drugs or formulations, under which the government may direct any manufacturer of any API or bulk drug or formulation to increase the production and to sell such ingredients to other manufacturers and to sell the formulations to institutions, hospitals or any other agency.
Bayer Zydus Pharma was a 50:50 joint venture between Bayer Pharmaceuticals Pvt Ltd and Zydus Lifesciences, established on January 28, 2011, for sale and marketing of pharmaceutical products in India. Bayer later acquired around 25% stake in the JV.
Bayer, on May 2, 2024, announced that it is acquiring the remaining 25% stake in the JV to secure full ownership. Bayer Zydus Pharma has been present in various therapeutic segments including cardiovascular diseases, diabetes, women’s health, ophthalmology and oncology.
Bayer's portfolio in India in the radiology segment include contrast media for computed tomography (CT), X-Ray, and magnetic resonance imaging (MRI), along with devices for precise contrast media administration. It currently has brands including Ultravist, Gadovist 1.0, and Magnevist in the contrast media segment.
According to Bayer, "Ultravist (iopromide) is an iodine-based low osmolar contrast medium indicated for a number of X-ray techniques such as computed tomography, angiography, and contrast-enhanced mammography.
Urografin is an older HOCM solution for injection is a contrast agent which contains iodine, used to clearly show the area of the body of the patient that the doctor requires to investigate, on x-rays. It is also used with CT Scanners and during angiograms in cardiac catheterisation procedures to assist the doctor. |