Parliament Question: Insulin Awiqi of Novo Nordisk

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 2168 TOBE ANSWERED ON 31ST JULY,2026 INSULIN AWIQI OFNOVONORDISK 2168.SHRISUBBARAYANK: COM. SELVARAJ V: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) whether it is a fact that Danish drug producer Novo Nordisk has launched a weekly basal insulin Awiqi for adults with Type1andType 2diabeticsina dozencountries includingIndia replacingthe daily insulin, if so, the detailsthereof; and (b) the opinion of the doctors about this new medicine and the response of the patients to the newinsulin? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT. ANUPRIYAPATEL) (a)& (b): Central Drugs Standard Control Organisation (CDSCO) has granted approval to M/s. Novo Nordisk India Private Limited for import and marketing, in India, for Insulin Icodec Solution for Injection (Awiqli®) 700 U/1 mL, 1050 U/1.5 mL & 2100 U/3 mL in pre- filled pen (r-DNAorigin) in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules thereunder, for the treatment of diabetes mellitus in adults. As per the approved Package Insert, the drug is to be administered once weekly through the subcutaneous route and is to be prescribed only by a registered endocrinologist or physician havingpost graduate qualification inmedicinebased onthe patient's clinicalcondition. The aforesaid drug has been approved by CDSCO for import and marketing in India based on the recommendations of the Subject Expert Committee (Endocrinology & Metabolism) in its meeting held on 19.06.2024 and after examination of its chemical, manufacturing and control (CMC) data, including clinical efficacy and safety data generated from global clinical trials, including Indian patients. The firm has also been directed to conduct a post-marketing surveillance study in the country under real-world clinical practice settings inIndia asperthe provisions of New Drugs andClinical TrialRules, 2019. The Subject Expert Committee consists of eminent experts drawn from different organizations such as Research Institutes, Regulatory Bodies, Medical Colleges & Hospitals andothereminentinstitutions/organizations. *******