Eli Lilly gets CDSCO Committee nod for marketing authorization for Insulin Lispro
New Delhi: In a major rejoice to Eli Lilly and Company (India) Pvt. Ltd., the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has recommended for grant of the marketing authorization of Insulin Lispro for controlling high blood sugar in diabetics.
However, the SEC approval came with conditions, wherein, the expert panel issued specific directions related to the name of the drug and Phase IV clinical trial in Indian patients.
This came in wake of the proposal presented by Eli Lilly for the grant of the marketing authorization of Insulin Lispro along with clinical data generated in the country.
Insulin Lispro is a type of insulin that is immensely effective in the treatment of type 1 and type 2 Diabetes. The drug is sold under the brand name of Humalog and is typically injected into the body using an injection under the skin or within an insulin pump.
The proposal was minutely scrutinized by the SEC Committee. Thereafter, the expert panel made some recommendations regarding the same in its 72nd meeting held on 16.12.2020 at CDSCO headquarter in New Delhi.
After detailed deliberation, the committee recommended for grant of the marketing authorization. However, the panel directed the firm to observe the following conditions;
"The name of the drug should be appropriate to distinguish it from the existing formulation of Insulin Lispro and it should also clearly claim that it is for use in adults only."
It further directed that;
"Firm should conduct a structured Phase IV clinical trial in Indian patients. Accordingly, the firm should submit the Phase IV protocol to CDSCO within three months from the date of approval for marketing of the drug."
To mention, the phase IV clinical trial provides a summary of all the non-clinical safety data already submitted while obtaining the permissions for Phase I, II, and III trials, with appropriate references. In case an application is made for initiating the Phase IV trial, complete details of the non-clinical safety data needed for obtaining the permissions for Phase I, II, and III trials must be submitted.
Also known as Lilly India, Eli Lilly and Company (India) Pvt. Ltd. is a wholly-owned subsidiary company of Eli Lilly and Company, a global biopharmaceutical company with its headquarters in Indianapolis, USA. Lilly India started its journey in 1993 as a joint venture with Ranbaxy Laboratories' Limited.