Dr Harish Iyer, CEO, Shantha Biotechnics
Sanofi's Shantha's human insulin, Insuman, is used in treating patients with type 1 & 2 diabetes, which demands insulin. The company has licensed the product in about 90 countries ever since its first introduction 17 years ago.
The manufacturing site is said to be spread across 13,400 square meters. The site is expected to have the capability of manufacturing up to 60 million cartridges per year.
According to the company, the unit will start its commercial manufacturing by 2019, and supplying to the regulated markets by 2020.
Tech-transfer
The company has a similar manufacturing facility located in Frankfurt, Germany. Insuman is a 'tech-transfer' project from Sanofi Frankfurt, using state-of-the-art Isolator technology.
"We are happy with the initial kick-start of the ground breaking ceremony which was recently graced by the presence of Hon'ble Chief Minister of Telangana State. The product has huge demand and its production is in its nascent stage, the first lot of Insuman is expected to roll out in 2020," revealed Dr Harish Iyer, CEO, Shantha Biotechnics.
Indian diabetes market
In India, it is estimated that approximately 65 million people have diabetes as per IDF (International Diabetes Federation) Atlas data.
Of these, it is further estimated that 42 lakh patients are on Insulin, of which 33 lakh patients are on regular human Insulin, and 9 lakh patients on analog Insulin.
"The Indian market is dominated by regular premix insulin, therefore, the need for Insuman in regular human Insulin category is high," added Dr Iyer while commenting on the market demand for Insuman in India.
Initially the company intends to produce Insuman for the Indian market primarily. Later it seeks to expand to other markets like the European Union (EU), if required.
Growth driver
"We are starting to invest in R&D projects for biotech in India but this is in early stages. It is too early to comment on the revenue that will be generated by Insuman... Diabetes is definitely a strong growth driver for us, both locally and worldwide," he pointed.
Shantha started its journey in Hyderabad in 1993. When asked about the manufacturing unit's strategic location, Dr Iyer expressed, "We wanted to incorporate the existing support of the local government and tap the availability of skilled labor for our facility."
Asia's biopharmaceutical giant Biocon too, is in the process of erecting its Malaysian plant in Johor with an investment of US $160 million, which is said to be Asia's largest integrated Insulin production plant.
The unit is expected to be functional in 2016 or 2017, according to Dr Kiran Mazumdar, CMD, Biocon.
While premix insulin tends to dominate the Indian market, there are many physicians who prefer to prescribe regular human Insulin given its advantages in terms of ease of use, availability and affordability.
Make in India
The industry has pinned its hopes to Narendra Modi's 'Make in India' campaign, hoping to see an increase in the number of investments in life sciences and bringing multinationals back on stage in the country.
Adding to it, Dr Iyer highlighted, "The "Make in India" also requires other elements that promise investment into infrastructure such as water, power, and supply chain among others, and good regulatory policies to really help to increase investments."
