CDSCO rejects Cipla’s application for marketing human insulin inhalation powder as SEC makes local trial compulsory

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An expert panel of the Central Drugs Standard Control Organisation (CDSCO) has insisted that a local clinical trial should be compulsorily conducted before marketing human insulin inhalation powder, a rapid-acting inhaled drug for glycemic control in adult diabetes patients, in the Indian market. A proposal by pharmaceutical major Cipla Limited to sell the drug on the basis of clinical data generated in the US has been denied by the regulator’s subject expert committee (SEC) for endocrinology and metabolism.

Last year, Cipla had entered into an exclusive distribution agreement with US-based MannKind Corporation for marketing the latter’s inhaled insulin, branded Afrezza, in India. The drug is the only US Food and Drug Administration-approved inhaled insulin available for patients suffering from diabetes. Under the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza in the domestic market, including clearance from the Drug Controller General of India (DCGI).

At its recent meeting, the SEC discussed the matter in detail and is learnt to have directed the company to submit the protocol for clinical trial for the committee’s review. “The firm has not presented specific justification from regulatory prospective for exemption of local clinical trial. Considering the route of administration and potential variability of performance of such product in Indian population due to various confounding factors, the committee recommended that the firm should conduct local clinical trial,” the panel observed, as per the minutes of the meeting. A copy of the minutes has been reviewed by Pharmabiz.

Available by prescription, insulin inhalation powder is a formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, the drug dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream in less than one minute. The company has claimed that this rapid absorption quality allows the drug to begin reducing blood sugar levels within 12 minutes of administration.

Globally, researchers are divided over the efficacy and cost-effectiveness of inhaled insulin. While its backers consider it as a paradigm shift in drug delivery, as it differs in route of administration and patient eligibility, critics cite reviews that concluded that it is not superior or cheaper to injected insulin.

The US FDA approved the first inhaled insulin, Pfizer’s Exubera, way back in 2006. But the drug maker later stopped manufacturing it as it was finding few takers. There were also concerns among clinicians that the drug might cause lung problems.

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