India is close to approving a weekly insulin jab made by Danish pharmaceutical company Novo Nordisk, the maker of the blockbuster Ozempic weight-loss drug, potentially offering relief to diabetics who require daily injections to maintain their sugar levels.
The Subject Expert Committee (SEC) under the drug controller has recommended permitting the import and sale of Insulin Icodec, The Economic Times has said.
Insulin Icodec, the first weekly insulin from Novo Nordisk, is expected to be a significant advancement in diabetes treatment and could solidify the company's position in the insulin market.
Moneycontrol couldn’t verify the report independently.
The drug has been approved by the European Medicines Agency (EMA) and Novo Nordisk has sought a similar approval in India for its various formulations: 700 U/ml, 1050 U/1.5 ml, and 2,100 U/3 ml.
In its recent meeting, the SEC recommended granting permission for the import and marketing of Insulin Icodec for the treatment of diabetes mellitus in adults. However, the committee has stipulated that Novo Nordisk must conduct an active Post Marketing Surveillance (PMS) study, the report said.
The drug is to be prescribed exclusively by registered endocrinologists or physicians with a post-graduate qualification in medicine.
The SEC has instructed Novo Nordisk to submit the PMS study protocol within three months of receiving marketing authorisation and to revise the product's package insert for approval by the Central Drugs Standard Control Organization (CDSCO), ET said.
Medical professionals have expressed optimism about the potential benefits of a weekly insulin regimen, noting improved patient compliance compared to daily injections. However, concerns about hypoglycemia risks and the practicality in emergency situations remain.
Dr Anoop Misra, Chairman of Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, stressed on the need for assessing insulin's cost and emergency management suitability in the Indian context, the report said.
Novo Nordisk had received approval from India's Drug Controller General (DCGI) in 2023 to conduct studies on the new weekly insulin aimed at managing blood sugar levels in individuals with type-2 diabetes.
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