Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • Vaccine Hub
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
  • Fact Check
  • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Fact Check
      • Bone Health Fact Check
      • Brain Health Fact Check
      • Cancer Related Fact Check
      • Child Care Fact Check
      • Dental and oral health fact check
      • Diabetes and metabolic health fact check
      • Diet and Nutrition Fact Check
      • Eye and ENT Care Fact Check
      • Fitness fact check
      • Gut health fact check
      • Heart health fact check
      • Kidney health fact check
      • Medical education fact check
      • Men's health fact check
      • Respiratory fact check
      • Skin and hair care fact check
      • Vaccine and Immunization fact check
      • Women's health fact check
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Abroad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Fact Check
    • Bone Health Fact Check
    • Brain Health Fact Check
    • Cancer Related Fact Check
    • Child Care Fact Check
    • Dental and oral health fact check
    • Diabetes and metabolic health fact check
    • Diet and Nutrition Fact Check
    • Eye and ENT Care Fact Check
    • Fitness fact check
    • Gut health fact check
    • Heart health fact check
    • Kidney health fact check
    • Medical education fact check
    • Men's health fact check
    • Respiratory fact check
    • Skin and hair care fact check
    • Vaccine and Immunization fact check
    • Women's health fact check
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Abroad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • News
  • Industry
  • Pharma News
  • DoP junks Skymap...

DoP junks Skymap Pharma review plea against NPPA for Fluconazole Tablets

Farhat NasimWritten by Farhat Nasim Published On 2020-06-22T11:35:49+05:30  |  Updated On 7 Dec 2022 12:04 PM IST
DoP junks Skymap Pharma review plea against NPPA for Fluconazole Tablets
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

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."

for more details click on the link below-

https://medicaldialogues.in/pdf_upload/pdf_upload-130532.pdf

Also Read: DoP Directs NPPA To Verify Documentary Proof Submitted By Cipla For Budesonide

dopSkymap pharmanppaFluconazole
Farhat Nasim
Farhat Nasim

    Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Show Full Article
    Next Story

    Editorial

    National Consensus 2025 on Role of Bisoprolol Across CV Continuum in Women: Top 10 Takeaways

    National Consensus 2025 on Role of Bisoprolol Across CV Continuum in Women: Top 10 Takeaways

    Relevance of Pioglitazone in Indian T2DM Care Continuum

    Relevance of Pioglitazone in Indian T2DM Care Continuum

    Azmarda Outperforms Generic Sacubitril/Valsartan in HFrEF Management, says new study

    Azmarda Outperforms Generic Sacubitril/Valsartan in HFrEF Management, says new study

    First Indian Consensus on Managing Refractory Gastroesophageal Reflux Disease Recommends Vonoprazan

    First Indian Consensus on Managing Refractory Gastroesophageal Reflux Disease Recommends Vonoprazan

    Re-visiting the Role of Pneumococcal Vaccination in Patients with Cardiovascular Diseases

    Re-visiting the Role of Pneumococcal Vaccination in Patients with Cardiovascular Diseases

    View All

    Journal Club Today

    Study Reveals Why Your Immune System Works Better in Daylight

    Study Reveals Why Your Immune System Works Better in Daylight

    View All

    Health News Today

    Health Bulletin 29/May/2025

    Health Bulletin 29/May/2025

    View All
    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok