Conduct Active Surveillance Study: CDSCO Panel tells Cipla on Idiopathic Pulmonary Fibrosis Drug Pirfenidone tablet
New Delhi: Denying the pharma major Cipla's request for waiver of an active surveillance study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has suggested the firm conduct an active surveillance study for Pirfenidone 200 mg tablets, which is a novel antifibrotic oral agent used for the treatment of idiopathic pulmonary fibrosis.
This came after the firm presented their proposal for a request for waiver of an active surveillance study before the committee.
Pirfenidone is an agent used for the treatment of idiopathic pulmonary fibrosis (IPF). It is an antifibrotic agent with anti-inflammatory and antioxidant properties that is used to treat idiopathic pulmonary fibrosis (IPF), which is a chronic, progressive form of interstitial pneumonia.
IPF is a rare and progressive respiratory disorder marked by the thickness and stiffening of lung tissue as well as the production of scar tissue. It's a form of chronic scarring lung disease that causes a steady reduction in lung function that's irreversible. Shortness of breath and a dry cough are two of the most common symptoms. Other symptoms include fatigue and unusually large, dome-shaped fingers and toenails. Pulmonary hypertension, heart failure, pneumonia, and pulmonary embolism are all possible complications.
Pirfenidone's exact mode of action and specific molecular targets are still unknown. The chemical, on the other hand, possesses anti-fibrotic, anti-inflammatory, and antioxidant properties. Suppression of TGF-1 (transforming growth factor-1), a major cytokine involved in fibrogenesis and extracellular matrix synthesis, is one key anti-fibrotic approach.
Pirfenidone 200 mg is available in India under the brands Pirfemac 200mg Tablet 10s from Macleods, Pirfenex 200 Mg Tablet 15s from Cipla, and Fibrodone 200mg Tablet 10s from Lupin.
Earlier, the Medical Dialogues Team had reported that Cipla had gotten approval from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct the single-dose and multiple-dose bioequivalence study (BE study) of Pirfenidone Extended Release Tablets 1200 mg.
In continuation, at the most recent SEC meeting for pulmonary, held on September 29, 2022, the committee thoroughly examined the drug-maker Cipla's proposal for a waiver of the active surveillance study of Pirfenidone 200 mg tablets.
After detailed deliberation, the committee reiterated its earlier recommendation and suggested that the firm needs to conduct an active surveillance study.
In accordance with the above, the committee directed the firm to submit a protocol for further review.
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