Biotechnology company Shreya Lifesciences has entered into an in-licensing agreement with US-based Generex Biotechnology Corp to market Oral-lyn, the country’s first needle-free insulin. Generex Biotechnology recently got the government’s approval to import and register the drug in India. Since insulin is a drug under government price control, the company, it is said would seek a price approval from the national pharmaceutical pricing authority (NPPA). Imported drugs are given upto 35% margin to cover post manufacturing expenses, while locally made ones get 100%. Shreya Lifesciences is expected to launch the drug in a couple of months after meeting regulatory requirements. The price of the drug is expected to be much higher compared to the injectable version. India, predicted to become the diabetes capital of the world, is home to around 40 million diabetic patients and the number is growing significantly every year. The market size of insulin in the country, now available in the form of injectables and cartridges, is around Rs 300 crore. Novo Nordisk, Eli Lilly, Wockhardt, Biocon and Shreya Lifesciences dominate the market. The new version of the drug, Oral-lyn, is delivered into the mouth using Generex’s proprietary device branded RapidMist. Unlike other inhaled insulin products, Oral-lyn does not reach the lungs, a company source said. It has been emphasised that Oral-lyn is not a new drug, but only a new delivery form. However, the company will have to collect data about the new version’s performance after it is made available in retail shops. This is part of a regulatory requirement for all new approved drugs called the post marketing surveillance or phase four clinical trials. Shreya’s in-licensed product enters the Indian market ahead of other Indian and multinational products’ versions. While Eli Lilly is learned to be developing an inhaled insulin, Pfizer Inc recently decided not to sell its groundbreaking inhaled insulin brand Exubera in the US for worries about its acceptance. Indian drug makers Biocon’s version of orally delivered insulin is expected to enter phase two clinical trials next year.