In 2006 I wrote about the news that Ocufors, a plant-based pharmaceutical product for glaucoma, had received regulatory approval from India's equivalent of the US FDA (the Drugs Controller General of India - DCGI).
Ocufors is a natural, plant-derived product that has been found to be 30% more effective at reducing intraocular pressure than existing glaucoma drugs, according to its manufacturer.
I have been following the story of the herb behind Ocufors for a few years. And I have been hoping to see a product like Ocufors come to market. Unfortunately, it is now 2008 and Ocufors is still not available in the US. At this moment we aren't even sure if it is available anywhere!
As a quick aside, I want to comment on the product name. It may be obvious, but Ocufors is a combination of "Ocu" for ocular and "fors" for forskolin, which is the active ingredient extracted from the herb.
As reported by Red Herring, there are two companies involved. The US patent is held by Sami Labs of Bangalore, India. According to Red Herring, Sabina , a US-based company, owns Sami Labs.
A more complete story, however, is that both companies were founded by the same individual. Sabinsa Corporation was founded in 1988 by Muhammed Majeed, Ph.D., who had traveled to the US from India in 1975. In 1991 Sami Labs was set up at Singasandra in Bangalore ( India ) as a research and development facility.
My speculation yesterday about an Ayurvedic connection proves correct. In fact, more so than I initially recognized. The following is a quote from a Sami Labs press release:
It was Dr Muhammed Majeed who introduced to the Americans that Ayurveda from India can act as a complete curative to their various ailments. The persistent efforts made by Dr Majeed in the early nineties in the field of Ayurveda did reap benefits among the Americans.
However, Sami Labs and Dr Muhammed Majeed are not applying some of the most important Ayurvedic principles when it comes to the products they sell.
The company's products are typically nutraceuticals. The company's own press releases refer to it as "the herbal nutraceutical major." Nutraceuticals are products that lie between pharmaceutical drugs and traditional herbal compounds. Nutraceuticals lack many of the safety factors built into traditional herbal compounds. See this article for a quick overview.
On a related point, we all need to be aware that standardized herbs are not the most desirable nor the safest form of herbs. Standardized herbs are more properly classified as nutraceuticals.
In fact, nutraceuticals should be viewed in a similar way to pharmaceuticals. In the second paragraph above, I described Ocufors as a "natural, plant-derived product." That is a partially correct statement. It would be far more accurate to just drop the word "natural" from the product's description.
Ocufors is a forskolin 1% Ophthalmic Solution which has been developed from the herb Coleus Forskohlii (also known as Makandi). The standardization process is not the only alteration of the natural herb.
What has not been disclosed yet in the press releases is how Sami Labs altered the chemical structure in order to achieve an ophthalmic solution. We do know it was not a trivial process.
In the 80s, pharma major Hoechst had done research on the use of Forkolin in treating glaucoma, but dropped the studies midway. We took it up and successfully made a solution out of the molecule, said Dr. Majeed.
The next interesting issue related to Ocufors is how long the drug's effect persists. Sami Labs is looking for ways to "package" the drug so that a single dose (drop) once every 24 hours is sufficient. That packaging represents yet another departure from the truly natural herb.
Ocufors represents an isolated herb that has been altered by standardization and then further altered in some unknown way to create an ophthalmic solution.
In Ayurveda, isolated herbs are generally not used. Neither are standardized herbs. It is known that wild-grown herbs are more potent than cultivated herbs. (Some claim they are 100 times more potent.) The way authentic Ayurvedic herbs are "standardized" is by gathering the wild herbs at the right time and under the right conditions.
Ayurveda holds that the right combination of herbs greatly increases their healing power while also reducing side effects. Clearly, Ocufors is not a true Ayurvedic medicine.
Unfortunately, I have not yet found a true Ayurvedic medicine that effectively lowers my IOP. Therefore, I remain enthusiastic about Ocufors.
However, that doesn't mean I think it is the ultimate treatment for glaucoma. If Ocufors is shown to be safe in follow up research, I will consider using it myself. I certainly want to get more detailed information on the six Indian clinical trials that led to Ocufors's approval. It will be interesting to compare them with the earlier research.
However, I would ultimately hope that I find some way to control my glaucoma without any pharmaceutical drugs, including Ocufors. I believe the traditional approaches of Ayurveda and/or Traditional Chinese Medicine, among others, hold promise.
I find it interesting that we are seeing a trend where pharmaceutical agents based on traditional herbs are being pursued by well-established companies and are gaining approval by drug regulatory agencies. However, that represents a continuation of the pharmaceutical mind-set with some influence from herbal sciences. It does not represent the authentic Ayurvedic approach.
In this article, I wanted to clarify where Ocufors stands in relation to Ayurveda.
As a postscript, I am including the full text of the company's recent press release.
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.