Sami Labs, the herbal major is now gearing up seek the US FDA approval for its drug for glaucoma developed from Forskolin with a brand name Ocufors. Although the product is ready to be marketed in India, the company is keen to go for a global launch and is seeking approval from the US regulatory authorities and therefore has stalled its domestic market launch.
The product, which has undergone extensive clinical trials in India showed positive results during its clinical studies conducted at the six locations in India. The drug has been approved by the Drugs Control General of India and also has a US patent. In India, the market for Glaucoma drugs is estimated to be around Rs 100 crore.
Going by the innovative features of the drug, Sami Labs wants to position it as an international product for Glaucoma, since the eye disorder is the second leading cause of blindness in the world and the third leading cause of blindness in India. The company is confident that the drug will come in as a major relief for patients across the world.
In India, there over 12 million cases affected with glaucoma accounting for 12.8 per cent of the blindness in the country. In the developing countries, this silent killer of vision affects around 67 million and there are no noticeable symptoms to detect it at earlier stages.
Forskolin is an extract prepared from the herb Coleus Forskohlii, a member of the mint family of plants grown in the wild in some parts of India. Sami Labs has got a US patent for the preparation of Forskolin from Coleus Forskohlii. The company is also developing a drug for a skin disease which is under clinical trials.
Based on these innovative product developments, Sami Labs is in the process of slating an expansion plan. It has been allocated the Karnataka Industrial Area Development Board land at the Special Economic Zone in Hassan in Karnataka. The plan is to set up a herbal active ingredient facility here. The investment details are being worked out and currently we are in process of taking a decision about the kind of unit to be set-up here, according K B Siva Prakash, chief operating officer, Sami Labs.
"There are two plans on the cards. One is to set up a facility on similar lines of our units at Hyderabad Kunigal, and Neelamangala in Karnataka. The other is to open up a dedicated unit for herbal actives," informed the Sami Labs COO.