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
  • NPPA exempts Torrent...

NPPA exempts Torrent Pharma Tapentadol Nasal Spray from price cap for 5 years

Medical Dialogues TeamWritten by Medical Dialogues Team Published On 2021-07-05T13:05:05+05:30  |  Updated On 5 July 2021 1:05 PM IST
NPPA exempts Torrent Pharma Tapentadol Nasal Spray from price cap for 5 years
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has granted a rare exemption from price cap to Torrent Pharmaceuticals' Tapentadol Nasal Spray for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country.

This comes in response to the application filed by Torrent Pharma for exemption under para 32 (i) of DPCO 2013 for the formulation "Tapentadol Nasal Spray 225mg/ml" in which each spray (0.1ml) contains Tapentadol Hydrochloride 22.5mg and Benzalkonium Chloride (50%) 0.02%w/v.

The issue was raised at the 89th meeting of the Authority under DPCO 2013, which was held on June 28, 2021, and was presided over by Shubhra Singh, Chairman, NPPA.

Also Read: NPPA alleges overcharging for cancer drug Tagrisso: AstraZeneca moves Delhi HC against Rs 157 crore demand notice

The authorities noted at the meeting that the document submitted by Torrent Pharmaceuticals included:

"a. Patent No. 355890 granted on 15.01.2021 to Torrent Pharma for an invention entitled "Pharmaceutical invention of Tapentadol" for the term of 20 years from 19th July, 2012, issued by the Patent Office, Government of India.

New drug approval was granted to the drugmaker on 02.09.2020 from the Central Drugs Standard Control Organisation (CDSCO), in form CT-23, to manufacture the new drug 'Tapentadol Hydrochloride Nasal Spray 225 mg/ml Nasal Spray' in which "Each spray (0.1ml) contains Tapentadol Hyd ro chlo ri de 22.5mg + Benzalkonium Chloride (50%) 0.02%w/v (as a preservative)".

Tapentadol is a centrally acting analgesic having both m-opioid receptor agonist and noradrenalin (norepinephrine) reuptake inhibition activity with minimal serotonin reuptake inhibition. This dual mode of action makes tapentadol particularly useful in the treatment of both nociceptive pain and neuropathic pain.

Proceeding further, the Authority also noted that CDSCO, in its email dated 26.05.20 21, stated that "... the new drug approval granted to Torrent Pharma for Tapentadol Nasal spray is covered under the Patent granted by the Patent Office vide Patent No. 355890."

After detailed deliberation, the authority observed that Torrent Pharmaceuticals fulfills the conditions as per para 32(i) of DPCO 2013 with respect to the formulation "Tapentadol Nasal Spray 225mg/ml" in which each spray (0.1ml) contains Tapentadol Hydrochloride 22.5mg + Benzalkonium Chloride (50%) 0.02%w/ v (As preservative).

As per para 32(i) of DPCO 2013, The provisions of Drug Prices Control Order shall not apply to, - (i) a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970) (product patent) and not produced elsewhere, if developed through indigenous Research and Development, for a period of five years from the date of commencement of its commercial production in the country. Accordingly, the Authority decided that,

An exemption should be granted to Torrent Pharmaceuticals Ltd under Para 32 (i) of DPCO 2013 for the said formulation for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country, subject to it being co-terminus with the duration of the Indian Patent. The authority also directed Torrent Pharmaceuticals to seek retail price approval, if applicable, three months before the expiry of the exemption granted under Para 32 (i) of DPCO 2013.

In view of the foregoing reasons, a gazette was rolled out saying,

" In exercise of the powers delegated under para 32 of the Drugs (Prices Control) Order, 2013 vide S.O. 1394 (E) dated 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, M/s Torrent Pharmaceuticals Limited is exempted from the provisions of DPCO, 2013 under para 32 (i) of the said order in respect of the formulation "Tapentadol Nasal Spray 225mg/ml" in which each spray (0.1ml) contains Tapentadol Hydrochloride 22.5mg + Benzalkonium Chloride (50%) 0.02%w/v (as a preservative) for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country. Further, the period of five years is co-terminus with the duration of the Indian Patent. "

The Gazette further added,

Torrent Pharmaceutical Ltd shall inform NPPA, the date of commercial marketing of the formulation "Tapentadol Nasal Spray 225mg/ml" in which each spray (0.1ml) contains Tapentadol Hydrochloride 22.5mg + Benzalkonium Chloride (50%) 0.02%w/v (As preservative) in the country and the Price to Retailer (PTR) and Maximum Retail Price fixed by the company in respect of the above said formulation by issuing a price list in Form V under DPCO, 2013."

However, Torrent Pharma has been directed to seek retail price approval for the formulation "Tapentadol Nasal Spray 225mg/ml" in which each spray (0.1ml) contains Tapentadol Hydrochloride 22.5mg + Benzalkonium Chloride (50%) 0.02%w/v (As preservative), if applicable, three months before the expiry of the exemption granted under Para 32 (i) of DPCO 2013.



tepentadol nasal spraynppaTorrent Pharmaceuticalsnasal sprayTorrent Pharmanational pharmaceutical pricing authoritydrug price control
Medical Dialogues Team
Medical Dialogues Team
    Show Full Article
    Next Story

    Editorial

    Real-World Case study: Darbepoetin Alfa for Chemotherapy-Induced Anemia in Metastatic Breast Cancer - Dr Aditya Murali

    Real-World Case study: Darbepoetin Alfa for Chemotherapy-Induced Anemia in Metastatic Breast Cancer...

    Aspirin in Primary Prevention- When to Consider?

    Aspirin in Primary Prevention- When to Consider?

    Featured image representing medico legal

    What's the Role of Expert Opinion in Medical Negligence?

    7- Point Discharge Protocol for AECOPD: Time to Inculcate in Practice

    7- Point Discharge Protocol for AECOPD: Time to Inculcate in Practice

    Aspirin Use in Women Aged 40-50 with Diabetes and Hypertension: Identifying the Ideal Candidates

    Aspirin Use in Women Aged 40-50 with Diabetes and Hypertension: Identifying the Ideal Candidates

    View All

    Journal Club Today

    Real-World Case study: Darbepoetin Alfa for Chemotherapy-Induced Anemia in Metastatic Breast Cancer - Dr Aditya Murali

    Real-World Case study: Darbepoetin Alfa for Chemotherapy-Induced Anemia in Metastatic Breast Cancer...

    View All

    Health News Today

    Health Bulletin 09/ May/ 2025

    Health Bulletin 09/ 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