Weekly-once insulin jab may soon come to India

In what could be a respite for people who need insulin jabs every day, a new weekly insulin dosage by Danish drug maker Novo Nordisk has got closer to approval in India.

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.

The proposed weekly insulin shot could prove to be a game changer as at present patients need to take insulin daily, according to doctors.

"It is wonderful to finally have insulin which is effective on a weekly basis. However, this comes with a caution, that of hypoglycemia, more than other basal insulins. Cost of this insulin and perceived problems in emergencies need to be ascertained in India," Dr Anoop Misra, chairman, Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, told ET

The company had got a go ahead from the Drug Controller General of India (DCGI) to conduct studies for the new weekly insulin which is meant to control blood sugar levels in people with type-2 diabetes, last year.

Over the last few years, the company has launched several drugs targeting diabetes, such as glucagon-like peptide-1 receptor, Ozempic (semaglutide) and its oral form, Rybelsus, gaining significant market share.