Lack of Strong Evidence: CDSCO panel rejects Glenmark proposal of using Nitric Oxide Nasal Spray for COVID-19 prevention

Published On 2023-02-15 12:30 GMT | Update On 2023-02-17 08:52 GMT

New Delhi: Citing lack of strong evidence on the use of Nitric Oxide Nasal Spray for prevention of COVID-19 infection, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected the drug major Glenmark's proposal for the additional indication of Nitric Oxide Nasal Spray.

This came after the drug major Glenmark presented their proposal before the committee regarding the use of Nitric Oxide Nasal Spray for prevention of COVID-19 infection

Glenmark's Nitric Oxide Nasal Spray is available in the market under brand name Fabispray. This Nitric Oxide nasal spray, available in the form of a simple nasal spray, is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. It is based on nitric oxide (NO), a natural nanomolecule with proven anti-microbial properties, and which has a direct effect on SARS-CoV-2, the virus causing COVID-19.

Nitric oxide (NO) is released in the nasal airways in humans. During inspiration through the nose, this NO will follow the airstream to the lower airways and the lungs. Nasally derived NO has been shown to increase arterial oxygen tension and reduce pulmonary vascular resistance, thereby acting as an airborne messenger.
Earlier, the Medical Dialogues Team had reported that the Central Drugs Standard Control Organization (CDSCO) panel, had given its green signal to pharmaceutical major, Glenmark Pharmaceuticals, to conduct a phase 3 clinical trial of Nitric Oxide nasal spray for Covid-19 treatment with following conditions:

1. RTPCR negativity at 2,4 and 8 days should be one of the primary end points.

2. People vaccinated with the COVID-19 vaccine should be excluded from study.

3. At screening, only a chest X-ray should be done (Not the CT).

4. Dosing interval & schedule of administration of the product should be clearly mentioned in the protocol.

Also Read:COVID Treatment: Glenmark Gets CDSCO Panel Okay For Phase 3 Trial Of Nitric Oxide Nasal Spray

Now in continuation, at the recent SEC meeting for COVID-19 held on 20th January 2023, the expert panel reviewed the proposal presented by the drug major Glenmark for the additional indication of Nitric Oxide Nasal Spray.

After detailed deliberation, the committee opined that the firm did not present strong evidence on the use of applied drug products for the prevention of COVID-19 infection.

In view above, the committee did not recommend approval of the proposal for the additional indication of Nitric Oxide Nasal Spray due to a lack of strong evidence for the proposed indication.

Also Read:Cadila Pharma gets CDSCO panel nod for Phase III CT Of Recombinant Rabies G Protein Vaccine

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Gilead Sciences gets USFDA nod for new Biktarvy indication for people with HIV who are treatment experienced, restarting antiretroviral treatment

2025-08-02 07:00 GMT

Lack of Strong Evidence: CDSCO panel rejects Glenmark proposal of using Nitric Oxide Nasal Spray for COVID-19 prevention

Similar News

Health Ministry Notifies Cosmetics Rules 2025, Empowers States To Suspend Licences

Biodeal Told To Justify Novel Delivery Claim In NPPA Exemption Plea For Midazolam Nasal Spray

CDSCO Panel Accepts Phase I Trial Data for Intas' Denosumab Biosimilar

Torrent Pharma: USFDA concludes inspection at Vizag facility with zero observations

Gilead Sciences gets USFDA nod for new Biktarvy indication for people with HIV who are treatment experienced, restarting antiretroviral treatment

USFDA issues 4 observations for Jubilant Generics Roorkee facility

Granules India arm gets 1 USFDA observation for Hyderabad facility

CDSCO Panel Clears PURE & CURE's Sickle Cell Trial With Conditions On Sample Size, Sites