Nandita Vijay, Bangalore
Friday, August
11, 2006

Sami Labs receives DCGI approval for Ocufors drug for Glaucoma care


Sami Labs, the herbal nutraceutical major, has received the permission from the Drugs Controller General of India to manufacture and market the new drug for Glaucoma developed from Forskolin that is a one percent ophthalmic solution. The drug will be sold under the brand name Ocufors. In India, the market for Glaucoma drugs is estimated to be around Rs 100 crore and Sami is gearing up to grab a 10 per cent market share. The company is also in the process of seeking international registrations in Europe, US and Australia.

There are only two innovative drugs that have come out of Indian pharma stables. While the first is Centchroman, a novel non-steroidal synthetic chemical agent marketed under brands Saheli by Hindustan Latex and Centron by Torrent Pharmaceuticals. Sami Labs is the second company to use the innovative Forskolin molecule that is recognized as a maiden global effort in the herbal sector. The ophthalmic solution for Glaucoma, which is the second leading cause of blindness in the world and the third leading cause of blindness in India comes in as a big relief for patients across the world, Dr Muhammed Majeed, chairman and managing director, Sami Labs told Pharmabiz.

Ocufors showed positive results during its clinical studies conducted at the six locations in India. This was in continuation of the research undertake by the pharma major Hoechst in the 80s where they had identified the efficacy of Forskolin in the treatment of Glaucoma but could not make an effective formulation and subsequently dropped the studies midway. Sami Labs took up the research and succeeded in making Forskolin a water-soluble substance, which is covered by a US patent, and went ahead with the phase III clinical trial on human beings, informed Dr. Majeed.

More than the market share, what is important is that an Indian herbal major has made a research breakthrough using natural sources and developed a formulation for Glaucoma, a degenerative disease of the optic nerve, usually caused by an increased pressure inside the eye, he added.

The company is in the process of identifying contract manufacturers in India and the production is expected to commence before 2006 end. For marketing, Sami is in a dialogue for partnerships.

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. In some areas people grow it and use it to make pickle. Sami Labs has got a US patent for the preparation of Forskolin from Coleus Forskohlii

The company has domesticated and popularized this plant which now being cultivated on over 10,000 acres in Tamil Nadu, Andhra Pradesh and Maharashtra.

The novel drug is 30 per cent more effective than the most popular drug for glaucoma in the world market today and has little or no side effects, thanks to its being a natural product. Its curative properties and safety aspects have been well accepted by prominent ophthalmologists who have undertaken the clinical studies, informed Dr Majeed.

In India, there are around 12 million Glaucoma cases 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 obvious symptoms to detect it at earlier stages.
Sami Labs is now working on a drug for Psoriasis that is entering phase III clinical trial in India. Drugs for asthma and cancer are also in the pipeline.