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NPPA directs Bayer Zydus Pharma to continue selling four scheduled formulations of Urografin

Gireesh Babu, New Delhi
Saturday, January 21, 2023, 08:00 Hrs  [IST]

The National Pharmaceutical Pricing Authority (NPPA) has directed Bayer Zydus Pharma, a joint venture between Bayer (South East Asia) and Cadila Healthcare, to continue production and sales of various strengths and sizes of diagnostic agent Urografin as against the company’s application to discontinue the scheduled formulations.

The drug price regulator, in the recent Authority meeting held in Delhi, 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 under Form IV as per the Schedule II of the Drugs (Prices Control) Order, 2013.

The Authority had already directed to continue import or production and sale of these formulations up to February 17, 2023, and to ensure the production is not reduced by more than 25 per cent of last year’s production in view of its majority market HS are for all the four formulations.

The 8th meeting of the Committee on Discontinuation under the Authority, held on December 6, 2022 also recommended to invoke Para 3 in the matter for further one year considering the substantial market share of the formulation and large public interest.

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.

“The Authority deliberated upon the matter in detail and decided to invoke Para 3 of DPCO, 2013 to direct Bayer Zydus Pharma to continue the production and sales of the subject scheduled formulations (i) Urografin 76%-20 ml (ii) Urografin 76%-50 ml (iii) Urografin 76%-100 ml (iv) Urografin 60%-20 ml up to February 29, 2024 and to ensure the production is not reduced by more than 25 percent of last year’s production,” averred the Authority.

According to Bayer, the drug Urografin 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, it says.

Bayer Zydus Pharma is focusing on prescription products especially for cardiology and women’s health care and on specialty therapeutics in oncology, haematology and ophthalmology. The synergy between the partners is that Bayer brings in novel products and international standards of administration and sales, while Zydus Cadila brings in its marketing and sales expertise as well as distribution network.


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