The Subject Expert committee (SEC) under India’s drug controller has advised the drug regulator to permit the import and sale of Novo Nordisk’s first weekly insulin-Insulin Icodec.
The launch of Insulin Icodec is touted to be another game changer that is expected to ensure the company’s lead in the insulin market.
The drug maker had approached the drug regulatory authority presenting the product approval from National Regulatory Authority (NRA) of country of origin i.e European Medicines Agency (EMA) for grant of permission to import and market Insulin Icodec 700 U/ml, 1050 U/1.5 ml, 2100 U/3ml.
The matter was deliberated in the SEC meeting last month, which recommended grant of permission for import and market of the Insulin Icodec 700 U/ml, 1050 U/1.5 ml, 2100 U/3ml for the indication of treatment of diabetes mellitus in adults.
However, the SEC has asked the company to conduct an active Post Marketing Surveillance (PMS) study. It also said that the drug should be prescribed only by the registered endocrinologist or physician having Post Graduate qualification in Medicine.Accordingly, it has asked the company to submit active PMS study protocol within three months of grant of marketing authorization permission and revised Package Insert (PI) of the product to CDSCO for approval.
Doctors are also hopeful that the new weekly insulin shot will help in patients’ compliance.
