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6/5/2018 From Herbal Folklore to Modern Medicine

From Herbal Folklore to Modern Medicine


Date of publication: September 20, 2013

National Integrated Research Program on Medicinal Plants, Philippines


In 1974, the University of the Philippines Manila (UPM), several other universities and governmental research
agencies working under the Department of Science and Technology (DOST) of the Republic of the Philippines
(the Philippines) collaborated on the formation of the National Integrated Research Program on Medicinal Plants
(NIRPROMP), with a mandate to distribute inexpensive medicine to the poor, to propagate the use of herbal
preparations with proven medicinal efficacy and identify scientifically validated medicine that would improve the
Filipino pharmaceutical industry. NIRPROMP was established to address the rising costs of imported
pharmaceutical products, especially those used for frequent ailments such as the common cold, fever and
headaches. At the time, the Philippine pharmaceutical industry was not self-sustaining in these medicines, and
companies were spending approximately 150 million Philippine pesos (around US $22 million at the time)
annually to import medicine. These imported medicines were also prohibitively expensive and out of the reach
of many patients. With this in mind, NIRPROMP prioritized reducing the country’s dependence on imports and
offering people more affordable pharmaceutical products through locally developed herbal medicine.

Traditional knowledge found its way to the metropolis of Manila (Photo: Flickr/Benson Kua)

One such innovation came in 1995, when NIRPROMP isolated vitex negundo, a large, hardy, five-leaved
aromatic shrub with bluish-purple flowers, as a natural source for developing an effective herbal medicine.
Known in the Philippines as lagundi, the plant thrives in both humid and arid regions throughout Africa and Asia
and has been used by local populations for hundreds of years to effectively treat wounds, headaches, ulcers,
skin diseases, diarrhea, and the common cold, among many others. After successfully scientifically identifying
the medicinal properties of each part of the plant, NIRPROMP developed a lagundi-derived formula for a
clinically proven cough and asthma medicine in tablet and syrup form.

Traditional knowledge

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Lagundi has been used for centuries by local populations in the Philippines for its medicinal properties, but
these were not described in detail until a book by Spanish Jesuit Father Colin that was published in 1900. In his
book, Father Colin wrote that lagundi was used regularly by Filipinos to treat wounds and as a pain medication.
In addition, he also found that they had vast traditional knowledge on the different medicinal properties of each
part of the plant. For example, while leaves are commonly used to ease headaches and cleanse ulcers, seeds
are used to treat skin diseases. The plant’s flowers are used to treat numerous diseases such as diarrhea and
cholera, and its black fruit is dried and eaten to alleviate and regulate intestinal discomfort. Finally, Father Colin
discovered that the plant’s roots are used to treat rheumatism and dysentery. This traditional medicinal
knowledge surrounding lagundi is commonly disseminated through herbolaryos – traditional healers who use
their traditional knowledge to prepare and administer herbal medicine. Herbolaryos have served as authority
figures on medicine in many local Filipino communities for generations, and have enjoyed a great deal of
respect and trust among many communities in the country.

Research and development


The development of modern lagundi-based medicine was the result of the herbal medicine research and
development (R&D) that has been continuously undertaken by NIRPROMP. Headed by researchers primarily
from UPM including Dr. Nelia Maramba and Dr. Conrado Dayrit, R&D focused on clinically validating traditional
medicine such as lagundi for use in the development of symptomatic drugs (treatment that focuses on the
symptoms of an ailment, not the cause). This is done through isolating the active ingredient and then developing
the associated drug. When research started, lagundi was not at the top of the list of potential candidates. In fact,
after an initial review of various research projects focusing on traditional medicine in the Philippines alone, the
R&D team discovered over 500 projects related to isolating active ingredients in plants, none of which had been
successfully commercialized.

The lagundi plant (Photo: Flickr/Ahmad Fuad Morad)

Dr. Dayrit suspected that one of the main reasons why these active ingredients were never commercialized into
a product was because consumers were generally unaware of the plants from which they originated and how
the ingredients were prepared into an herbal drug. Dr. Dayrit felt that this lack of knowledge bred distrust among
consumers of companies trying to develop new drugs based on relatively unknown plants, and that R&D should
be focused only on traditional medicine based on plants that are well known and trusted among the population.
After conducting a survey of consumers, the research team learned that although people generally do not trust

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medicine based on a plant they were unaware of and manufactured by an unknown company, many do trust
herbolaryos. The R&D focus therefore shifted from journal articles of various research programs to herbolaryos,
and NIRPROMP started collecting folkloric data and conducting scientific tests to validate the herbolaryos’
claims.

With the help of the National Science and Technology Authority of the University of the Philippines Los Baños,
from 1977 to 1982 NIRPROMP conducted a detailed survey of herbolaryos to identify those herbal preparations
that have promising medicinal properties. The survey included interviews with 1,000 herbolaryos and had
detailed accounts of the herbs they used and any side effects caused. Out of the 1,500 plants identified,
NIRPROMP scientifically validated that 480 of them contained beneficial medicinal properties.

Another R&D project was carried out in tandem and based on the information provided by the herbolaryos.
Members of this project poured over the records of the Department of Health to find out the leading cause of
morbidity at the time. The gathered data was used to prioritize the symptoms and/or diseases that herbal
medicine would have the best potential to treat. Researchers discovered that respiratory problems were among
the most common symptoms that held the potential to be treatable with traditional medicine.

Armed with this cache of data, the researchers developed five criteria with which to test plants against: safety,
efficacy, quality, availability of raw material, and propagation studies of the raw herbs. The first three criteria
were necessary to ensure that the medicine would be safe and effective, while the last two would ensure the
sustainability of the supplies for R&D, clinical trials and eventual commercialization. Long and detailed testing of
each of the 480 plants ensued, and NIRPROMP identified ten plants that were scientifically validated as safe,
effective and sustainable.

Lagundi was one of these ten plants, and because respiratory problems were a primary concern among the
population, it was chosen to be the basis for a medicine to alleviate cough and asthma symptoms. The
beneficial properties of lagundi were first recognized during the survey of the herbolaryos, in which 70% of them
vouched for the plant’s efficacy in treating cough. The lack of any reports of adverse side effects bolstered their
claims, and the abundance of the plant throughout the Philippines made lagundi R&D even more attractive.

Through scientific and clinical tests, the research team identified four active ingredients of lagundi and found the
effect of each: (1) as a relaxant of the air passages in the lungs; (2) as an anti-histamine; (3) as an anti-
inflammatory; and (4) as an anti-asthmatic. While each ingredient acted weakly when administered on its own,
they produced a powerful cough suppression effect when used together, and without any adverse side effects.
With these promising results in hand, NIRPROMP developed a lagundi-based cough medicine in tablet form
and launched clinical trials in the late 1980s, with 119 patients suffering from mild to moderate cough
participating. Each patient was given either a placebo or the lagundi medicine, and those who received the
lagundi medicine exhibited substantial positive medical responses without any adverse reactions or side effects.
By 1993, researchers had successfully developed a lagundi-based cough medicine in tablet form. In October
1995, the Philippine Department of Health released a list of officially endorsed plants that exhibit effective
natural medicinal properties with proven therapeutic value. Lagundi was among the plants listed, along with the
nine other plants NIRPROMP isolated through its earlier R&D.

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Lagundi was one of ten plants chosen for further research due to its properties at alleviating cough and asthma symptoms (Photo:
Flickr/Kristy Faith)

Invention
Following the successful development of lagundi cough tablets, NIRPROMP researchers worked to also
develop the medicine in a syrup form. Children and the elderly make up a significant portion of the demand for
cough medicine, but tablets can be difficult for them to take. In 1999, NIRPROMP successfully altered the
formulation for lagundi cough tablets into a lagundi cough syrup, which retains all the medicinal properties of the
tablets, but is in a form that is easier to administer.

The new syrup formulation uses decoction to extract the organic compounds from lagundi leaves. Decoction
involves drying the lagundi leaves and grinding them through a mesh until a fine powder is formed. Distilled
water is then added to moisten this powder, and it is then boiled for approximately fifteen minutes with
occasional stirring in a low to medium heat (which prevents possible degradation of the active ingredient). The
resulting lagundi decoction is set aside to cool and then filtered or strained. Sucrose is then dissolved in the
prepared decoction using a turbine mixer, after which the compound is aged for about three days. A small
amount of methyl and propylparaben (a preservative) is ground into a fine powder, and propylene gylco (an
organic compound used as a solvent) is added until the propylparaben is completely dissolved. This is
introduced into the aged sucrose and lagundi decoction compound. After mixing well, a small amount of citric
acid and orange oil is added. Lastly, a sufficient amount of distilled water is mixed in to obtain the required
volume. This is thoroughly mixed together until a syrup solution is formed in the appropriate consistency.

Utility model
Because NIRPROMP’s research was funded by DOST and was a collaboration between UPM and PCHRD, a
sectoral council of DOST, all intellectual property (IP) is managed and owned by DOST. In order to protect the IP
behind lagundi cough syrup formula and promote commercialization, in 1999 DOST therefore applied for a utility
model with the Intellectual Property Office of the Philippines (IP Philippines) for an herbal pharmaceutical
composition that is based on lagundi. The utility model was approved and issued in February 2001.

Licensing and commercialization

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Although NIRPROMP was responsible for the R&D and clinical trials of
the lagundi cough medicine in tablet form, PCHRD was responsible for
coordinating and facilitating commercialization. When the lagundi cough
tablet formulation was ready for commercialization, PCHRD organized
informational forums to gauge interest from local pharmaceutical
companies. Many of them expressed interest and as such in 1993
PCHRD developed and announced a non-exclusive licensing agreement
system. Under this agreement, the licensee pays an upfront fee for the
technology and royalties based on gross revenues less value added tax
and the typical volume discount given to large drug store chains. As the
funding entity of PCHRD and NIRPROMP, all royalties and fees are paid
to DSOT. Each licensee is responsible for registering their derived
products with the Philippine Food and Drug Administration (then known
as the Bureau of Food and Drugs). An important part of the license is the
provision of the results of the clinical studies which verify the safety and
effectiveness of the drug. Without these, the drug cannot be sold as a
legal medicine in the Philippines.
Dr. Neila Maramba, a founding member
of NIRPROMP (Photo:NIRPROMP)
The first licensee for the lagundi tablet technology was Herbafarm, a
Filipino pharmaceutical company which used lagundi grown from its own
farms and at an in-house manufacturing facility at a DOST compound.
Herbafarm launched its lagundi products in 1994. Other licensees soon followed, one of which was Pascual
Laboratories (Pascual), a large Filipino pharmaceutical company that would go on to become the most
successful licensee of lagundi technology. Pascual’s product based on the PCHRD lagundi formula was
approved by the Bureau of Food and Drugs in 1996 and continues to be on sale in the Filipino pharmaceutical
market.

Despite the successful commercialization of the lagundi cough medicine formulation, it faced numerous
difficulties penetrating the market early on. At the time, medical professionals and some in the public did not
consider herbal medicine to be an effective form of medical therapy. To counter this problem, Pascual launched
a marketing campaign to improve the image of herbal treatments and lagundi cough medicine. The company’s
first strategy was to promote the drug to medical practitioners directly, especially those at Rural Health Units
(RHUs). RHUs are small government funded clinics in rural areas, and as such they were very open to using
lagundi cough medicine because it was developed through a government funded program. To further verify the
effectiveness of the drug, in 1997 Pascual submitted it to the International Exhibition of New Products,
Inventions and Techniques in Geneva, Switzerland, where it was awarded the silver certificate for R&D. The
company took this award back home and used it extensively in advertising and developing awareness, and it
helped change the opinions of medical professionals and skeptical consumers.

Pascual and other pharmaceutical companies marketing lagundi cough medicine picked up the pace of their
advertising campaigns in the late 1990s and 2000s. By 2006, Pascual was running television commercials
during popular morning shows and advertising on the radio and billboards. Other companies followed suit, and
their successes increased interest in licensing the technology. In 2009, Herbs and Nature Corporation entered
into a licensing agreement and launched its own lagundi cough medicine, and in 2010 New Market Link
Pharmaceutical Corporation, Herbcare and Pharmacare all did the same and introduced lagundi cough
medicine products to the market.

Trademarks

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An integral part of the success of the efforts of Pascual and other companies was
the renewed brand image they helped create for lagundi, and this was facilitated
by the strong brand names the companies created for their respective products.
Recognizing the need to protect its popular brand names, in January 2011
Pascual applied for trademarks with IP Philippines for Ascof, Ascof Lagundi, and
a stylized logo that includes an image of a lagundi leaf. Pascual’s efforts paid off,
as by early 2011 the company’s lagundi cough medicines became the second
most popular cough medications in the Philippines. In February 2009, Trevenodd Pascual's trademark
application (IP Philippines
Corporation (Trevenodd), a newcomer to the industry, applied for a trademark Application No. 42011000094)
registration for its Plemex brand lagundi cough medicine, which was registered in
August of that same year.

Technology transfer
Until 2009, the technology for lagundi tablets and syrup was transferred through licensing agreements between
PCHRD, a government entity, and the private sector. However, according to Republic Act 10055, otherwise
known as the “Philippine Technology Transfer Act of 2009” (the Act), technology developed backed by
government funding must be completely transferred to entities such as universities or companies that can
translate this technology into useful products and services. The goal of the Act is to promote and facilitate the
transfer, dissemination, and effective use, management and commercialization of IP, technology and knowledge
resulting from R&D funded by the government for the benefit of the national economy and all Filipino people.

Based on this new policy, PCHRD formally transferred the lagundi cough medicine syrup formula to UPM, which
would then be tasked with further R&D, licensing and commercialization activities. In October 2010, Azarias
Pharmaceutical Laboratories, Inc. (Azarias) made an application to UPM to become the first licensee of lagundi
syrup under this new framework. Following the evaluation and recommendation of PCHRD, the agreement was
officially signed in January 2011. The licensing agreement was the first of its kind between a public R&D
organization (UPM) and a private corporation (Azarias) in the Philippines since the Act was ratified in 2010.

Business results
When lagundi cough medicine was first launched on the market in 1994, it faced an uphill battle of consumer
skepticism. However, through a consecutive series of lucrative licensing agreements and concerted efforts to
improve the image of herbal medicine and lagundi derived products, the drug has been a success for the many
companies that have commercialized it as well as NIRPROMP, PCHRD and DSOT. This is evident in the rapid
increase in royalties received by DSOT, which rose from PHP 160,000 (approximately US $4,000) in 1997 to
PHP 9,751,000 (approximately US $210,000) in 2009.

The successful commercialization of lagundi has also been beneficial for the many farmers that grow and sell
the shrub to manufacturers. One such example is the case of the lagundi farmers on the southwestern island of
Palawan. With the help of a non-governmental organization, the farmers were able to secure a distribution deal
with Pascual to produce lagundi. Under the terms of the deal, Pascual lent money to the farmers to install solar
powered dryers and mills so that they could produce the lagundi in powdered form. With the help of this new
equipment, the farmers were able to produce more lagundi than before and improve their processing ability.
Within two years the farmers not only paid Pascual back, but also became an important supplier of lagundi,
which significantly improved the livelihood for the farmers, their families and communities.

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Farmers in Palawan were able to benefit economically through a distribution agreeement with Pascual (Photo: Flickr/CédricBuffler)

Championing technology transfer and herbal medicine


Passed down for generations, the traditional knowledge of lagundi has been transformed into a safe,
scientifically validated herbal drug. With the help of the Philippine government and collaborations between
universities and pharmaceutical companies, the technology was transferred and smart use IP structures such as
utility models and trademarks ensured its success. Once only in the domain of herbolaryos, the lagundi plant
now uplifts the livelihood of local farmers and brings an affordable, safe and effective medicine for all.

Sources, references and related links


This case study is based on information from:

A Review on Vitex negundo L. – A Medicinally Important Plant


Filipino firm granted license to distribute lagundi syrup
Overview of devolution of health services in the Philippines
Philippine Council for Health Research and Development
TOFIL Awardee - Dr. Nelia Cortes-Maramba, M.D.
University of the Philippines - Manila
WIPO National Workshop on IP & Technology Management for Universities and R&D Institutions - Invention
Disclosure Process, University of the Philippines

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