Sun Pharma gets CDSCO panel nod to study COPD drug combination

Written by Dr. Divya Colin Published On 2023-04-06T18:00:11+05:30 | Updated On 7 Oct 2023 3:45 PM IST

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New Delhi: Pharmaceutical major, Sun Pharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the active Post-marketing Surveillance (PMS) Study of the fixed-dose combination drug Fluticasone Furoate 200mcg plus Vilanterol 25mcg powder for inhalation.

However, this approval is subject to conditions that the follow-up of the study should be up to 06 months.

Furthermore, the expert panel suggested, "The details of the last visit including the test parameters should be mentioned at 06 months and telephonic follow-up should be done in the 4th and 5th months to assess the symptom analysis so as to rule out any worsening or exacerbation."

This came after the drug major Sun Pharma presented the active post-marketing surveillance (PMS) study protocol before the committee as per the condition mentioned in Form CT-23 dated 31.10.2022.

The fixed-dose combination drug Fluticasone Furoate 200mcg plus Vilanterol 25mcg powder for inhalation is used in the treatment of Chronic obstructive pulmonary disease (COPD) and Asthma.

Fluticasone furoate works by blocking the production of certain chemicals in the body which causes inflammation (redness and swelling) and allergies. Vilanterol works by relaxing air passages in the lungs, making breathing easier.

At the recent SEC meeting for Pulmonary held on the 21st of March 2023, the expert panel reviewed the active PMS study protocol of the FDC drug Fluticasone Furoate 200mcg plus Vilanterol 25mcg powder for inhalation.

After detailed deliberation, the committee recommended for conducting the active PMS study with the following conditions:

1. The follow-up of the study should be up to 06 months.

2. The details of the last visit including the test parameters should be mentioned at 06 months accordingly.

3. Telephonic follow-up should be done in the 4th and 5th months to assess the symptom analysis so as to rule out any worsening or exacerbation.

In addition, the expert panel suggested that the result of the study should be presented before the committee for review.

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Dr. Divya Colin

Doctor of Pharmacy

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.