MSN Labs Gets SEC Nod for Roflumilast as Starting Dose in COPD Therapy
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended the grant of permission to manufacture and market Roflumilast Tablets 250 mcg by MSN Laboratories Pvt. Ltd., indicated as a starting dose in the already approved indication for Chronic Obstructive Pulmonary Disease (COPD).
The submission, registered under file number SND/MA/23/000296, was reviewed during the SEC (Pulmonary) meeting held on September 10, 2025, at CDSCO (HQ), New Delhi.
During the meeting, MSN Laboratories presented their proposal seeking approval for the manufacturing and marketing of Roflumilast Tablets 250 mcg as an initial dose for the first four weeks of treatment. The firm clarified that this dose is not intended for therapeutic use but serves as a starting dose to help patients gradually adjust to therapy before escalating to the standard 500 mcg maintenance dose.
The committee noted that Roflumilast 250 mcg is already approved in the United States as a starting dose, administered during the first four weeks of treatment, after which the dose is increased to 500 mcg once daily for continued therapy. In India, the 500 mcg strength is already approved and available for therapeutic use in COPD management.
After detailed deliberation, the committee recommended the firm to manufacture and market Roflumilast Tablets 250 mcg for usage up to four weeks, followed by the 500 mcg dose in the already approved indication.
However, the approval is subject to the condition that the company must conduct an Active Post-Marketing Surveillance (PMS) study. The firm has been directed to submit the PMS protocol to CDSCO within three months for review by the committee.
Roflumilast, a selective phosphodiesterase-4 (PDE4) inhibitor, is used to reduce inflammation in the lungs and prevent COPD flare-ups.
