Mar 08,2024
The National Pharmaceutical Pricing Authority (NPPA) has directed Bayer Zydus Pharma, a joint venture between Bayer and Zydus Cadila, to continue production and sales of various strengths and sizes of diagnostic agent Urografin for one more year as against the company’s application to discontinue the scheduled formulations.
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 under Form IV as per the Drugs (Prices Control) Order, 2013.
The Authority directed the company to continue production of these formulations till February 28, 2025, extending the order it has issued in January, last year.
In the latest decision, the Authority 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.
The Authority, in January 11, 2023 directed the company to continue import or production and sale of these formulations till February 29, 2024.
It may be noted that the 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 re-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 and (iv) Urografin 60%-20 ml for a period of one year i.e. up to February 28, 2025 and to ensure the production is not reduced by more than 25 per cent of the production level at the time of discontinuation application,” said the Authority in its latest meeting.
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.
Source: Pharmabiz