Cipla is set to introduce Afrezza, an inhaled insulin developed by U.S.-based MannKind Corporation, to the Indian market, marking a new milestone in diabetes management. Afrezza, a rapid-acting insulin delivered through an inhaler rather than injections, recently received approval from India’s Central Drugs Standard Control Organisation (CDSCO) for exclusive distribution and marketing. The drug had previously secured regulatory approval in the U.S. nearly a decade ago.
The innovative delivery system offers a needle-free alternative for diabetes patients, especially those on multiple daily insulin injections. However, experts caution against its use for individuals with asthma, COPD, or other lung conditions.
“Afrezza is a short-acting insulin designed to be taken before meals to control post-meal sugar spikes,” said Dr. Saptarshi Bhattacharya, Senior Consultant at Indraprastha Apollo Hospitals, New Delhi. He emphasized that the inhaled insulin is an add-on therapy for patients already on mixed regimens of long-acting and short-acting insulins. Dr. Abhijit Bhograj, endocrinologist at Manipal Hospital, Hebbal, added that the product “offers convenience” but must be avoided by those with severe lung ailments.
Afrezza’s re-entry into the global market is significant, as previous inhaled insulin products—such as Pfizer’s Exubera and Sanofi’s earlier version of Afrezza—were discontinued due to shifting business priorities rather than concerns over safety or efficacy. Diabetologists have stressed the importance of ongoing long-term studies to monitor the product’s performance.
Why Cipla Chose Afrezza
Dr. Jaideep Gogtay, Cipla’s Global Chief Medical Officer, explained that the decision to bring Afrezza to India was based on Cipla’s expertise in inhalation therapies and the drug’s unique profile. “Afrezza mimics the body’s natural insulin response, dissolving rapidly in the lungs and delivering insulin to the bloodstream within 12 minutes,” he said. The product helps counter sugar spikes that occur during meals, making it particularly effective for patients with Type 1 and Type 2 diabetes.
Clinical trials in India have shown promising results. A Phase 3 study involving 216 patients demonstrated a significant reduction in HbA1c levels when Afrezza was added to oral anti-diabetes medications, Cipla revealed.
As reported by Hindu Businessline, Cipla plans to launch the product by the end of the current financial year (March 2025). Pricing details are still being finalized. Industry experts believe the inhaled insulin could mark a turning point in diabetes care, offering greater convenience to patients and expanding treatment options in India.