Cipla gets CDSCO nod to launch inhalation insulin

MUMBAI: Cipla on Wednesday said it has received the nod from Central Drugs Standard Control Organisation (CDSCO) for the exclusive distribution and marketing of Afrezza - inhalation human insulin in India.

Afrezza is a rapid-acting insulin delivered through an inhaler as compared to current insulins which are given as injections. Taken at the beginning of a meal, Afrezza dissolves rapidly upon oral inhalation into the lungs and delivers insulin quickly to the bloodstream.

Cipla said Afrezza starts working in as early as 12 minutes and helps in reducing the rapid increase seen in sugar levels with meals. The effect of Afrezza lasts for about 2-3 hours and it closely resembles the body’s own response to insulin.


Afrezza, is developed and manufactured by MannKind Corporation (MannKind) USA, is used to improve glycemic control in adult patients with diabetes mellitus.

Cipla said it will make this drug accessible to all and empower millions to take control of their health with greater ease.

This is the first and only noninjectable insulin to be developed for patients of both type 1 and type 2 diabetes mellitus.

“Having pioneered inhalation therapy in India, we are proud to extend our innovation portfolio to diabetes management by partnering with MannKind for distribution of Afrezza.," said Umang Vohra, managing director and global CEO, Cipla.

Cipla has conducted a phase 3 clinical trial conducted in 216 patients in India showed a significant reduction in HbA1c levels with Afrezza when added to oral antidiabetes medications.

Afrezza has been evaluated in over 70 clinical studies involving more than 3,000 patients overall. Afrezza has been approved in the US for more than 10 years and has been prescribed for tens of thousands of patients. MannKind will supply Afrezza to Cipla, who will be then responsible for sales and marketing activities in India.