DoP junks Skymap Pharma review plea against NPPA for Fluconazole Tablets
New Delhi: In a major setback to Skymap Pharmaceuticals Limited, the Department of Pharmaceuticals (DoP) has rejected the review application filed by the drugmaker against a notification issued by the National Pharmaceutical Pricing Authority (NPPA) for fixing the retail price of Fluconazole Tablets 300mg.
In 2019, the firm had filed an application for the retail price approval of Fluconazole. NPPA notified the retail price approval as Rs.16.16. The drugmaker contended that earlier NPPA's authority fixed the ceiling price of Fluconazole 200 mg tablet at Rs. 18.38/ tab and Fluconazole 400 mg tablet at Rs. 30.57/ tab based on the WPI increased 4.2662%.
For the computation of Retail price for Fluconazole 300 mg tablet, NPPA used the PTR of the product of M/s Systopic Laboratories Ltd. as per Pharma Trac data and the draft working sheet was uploaded on NPPA website in 2019. NPPA used the Pharma Trac data of a 'Without Price Approval (WPA)' case to approve the Retail Price.
In view of the above, the company asked DoP to review its form- I application by considering ceiling price of Fluconazole 200 mg & 400 mg tablet which are approved by NPPA, because how the retail price of Fluconazole 300 mg tablet can be less than Fluconazole 200 mg tablet.
Responding to the contentions, NPPA stated that NPPA's authority fixed the Retail Price of Fluconazole 300 mg at Rs. 16.16 per tablet excluding GST in accordance with Para 5 of DPCO, 2013. The company's contention that the NPPA used the Pharmatrac data of a "Without Price Approval (WPA)" to approve the Retail Price of their Form-I application, has no merit. On examination of the Pharmatrac data, it was found that Systopic Laboratory Ltd launched AF 300 mg in Jan 2003 when DPCO, 2013 was not in force. Therefore, AF 300 mg tablet doesn't come under the purview of the WPA clause.
The authority further mentioned that the contention raised by the company that the retail price of Fluconazole 300 mg tablet cannot be less than Fluconazole 200 mg tablet, it may be stated that similar aberration has also been noted while fixing prices of some other formulations i.e. higher strength of a formulation has a lower price than its lower strength. However, as per the existing mandate, NPPA fixes the retail price based on market-based methodology as per para 5 of DPCO, 2013 and NPPA has strictly followed the provisions of the DPCO, 2013. In view of the above, the contention of the company has no merit.
"The company did not make any representation against uploading of the worksheet prior to its notification," NPPA said.
Examining the case, DoP observed that before notifying the retail price of Fluconazole Tablets 300mg, the NPPA displayed the draft calculation sheet on its website on 18.10.2019, giving ample opportunity to the company to file its objection, if any. However, the company did not make any representation against the draft worksheet uploaded on the website by the NPPA.
As per existing provisions in para 5 of DPCO, the retail price of a new drug is fixed by considering the PTR of the similar formulation available in the domestic market. The NPPA fixed the retail price of Fluconazole Tablet 300mg by considering the PTR of formulation with the brand name 'AF' of 300mg strength being manufactured by Systopic Laboratories Ltd. as per the provisions of DPCO. Therefore, the objection raised by the company that the price fixed for 300mg is less than the retail price of 200mg has got no merit, as the retail price is fixed strictly as per provisions in the DPCO.
As regards the contention of the company that the NPPA has used the Pharmatrac data of a "Without Price Approval (WPA)" case to fix the retail price of its product, the NPPA clarified that the product AF 300mg, (the PTR of which was considered while fixing the retail price) was launched by M/s Systopic Laboratory Ltd. in January 2003 when DPCO 2013 was not in force. Hence, the AF 300 mg tablet is not a WPA case and, therefore, the contention of the applicant does not have merit.
Subsequently, DoP rejected the review application while noting;
"The retail price of Fluconazole Tablets 300mg was fixed vide SO 4103(E), dated 14.11.2019 by strictly following the provisions in para 5 of DPCO. Hence, the present review application is not sustainable and stands rejected."
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