By Shalini Bhardwaj

New Delhi [India], September 30 (ANI): The Central Drugs Standard Control Organisation (CDSCO) has approved Danish drugmaker Novo Nordisk's once-a-week injection for patients suffering from Type 2 diabetes.

In a statement provided to ANI, Novo Nordisk has stated that Ozempic is intended for individuals with Type 2 diabetes and will be available only upon a doctor's prescription.

'Ozempic is meant for people with type 2 diabetes and will be available upon a prescription from a doctor,' it said.

'There will be an approved Prescribing Information with the product. It has to be used as per the approved Prescribing Information,' said Senior Official.

'Semaglutide Injection (Ozempic@) is indicated for the treatment of Adults with Insufficiently Controlled Type 2 Diabetes Mellitus as an adjunct to Diet and Exercise,' CDSCO approval read.

'The Indian drug regulator, Central Drugs Standard Control Organisation (CDSCO), has approved Ozempic[?] (injectable semaglutide) for the Indian market. The global blockbuster medication has gained worldwide recognition for its demonstrated effectiveness in treating type 2 diabetes. Its robust clinical results and strong patient acceptance have made injectable semaglutide a preferred solution for millions and are setting new standards in diabetes care globally,' said Novo Nordisk India in the statement. According to the Managing Director, Novo Nordisk India, Vikrant Shrotriya, said, 'India is a key market for Novo Nordisk and we strive to introduce the best-in-class innovations for the people who need it the most. At the same time, we are dedicated to improving access and affordability, so that more patients can benefit from our therapies and achieve better health outcomes.' 'With the highly anticipated launch expected soon, Novo Nordisk will now complete its semaglutide portfolio in India, providing a range of treatments to address diverse patient needs-- oral semaglutide for diabetes, advanced obesity management through Inj Semaglutide 2.4 mg and soon Inj Semaglutide 0.25, 0.5 & 1.0 mg for type 2 diabetes,' said Novo Nordisk 'Injectable semaglutide, indicated for Type 2 diabetes, also lowers the risks of major adverse cardiovascular events (MACE) and chronic kidney disease, positioning it as a well-rounded therapy for patients,' it further said.

'Semaglutide is a very useful injection for treating type 2 diabetes. It belongs to a class of drugs called GLP-1 receptor analogues, and you have had different receptor analogues in the past, and others, but they have not been as powerful as semaglutide. So I'm glad that Ozempic has now been approved in India, previously known as Wegovy. Ozempic is the same as integral, same integrator type, which is specifically for the treatment of type two diabetes. This drug helps not only in controlling diabetes but also in reducing weight. It has also been approved for fatty liver,' said Dr V. Mohan, Chairman, Madras Diabetes Research Foundation.

On whether it can be misused, he said, 'This model can be misused by pharmacists or quacks or others who don't know much about the drug. First of all, I think the approval states that MDs, physicians, and endocrinologists should be the only ones to use it. That's what the original approval was for. And of course, any drug can be misused. So if there's an indication for using it, particularly for those who are overweight, and they have an indication because it costs a potentially expensive drug.'

'They're not cheap, and therefore they should be used where needed, so that those who need the drug will not otherwise go unattended in the US. They'll run out of the drug, and they will not give it to those who need it. So yes, it can be misused. It must be strictly under the purview of the doctors, and only under perception,' he further added. (ANI)