R&D model: The Philippine medicinal plants’ development

(Second of two parts)

The research and development process

The standard research process has been established by the NIRPROMP Team based at UP Manila. It is composed of three major components:

u u u— for the supply of raw materials:

• Identification of plant/plant parts and disease indication;

• Collection/authentication of plants/establishment of gene bank;

• Propagation;

• Harvesting techniques, handling procedures, facilities, storage, labeling;

• Postharvest techniques (proper sanitation and clean facilities).

2. The medical component — for the validation of formulations on human subjects:

• Pharmacologic — effect/mechanism of action/safety of preparations;

• Toxicologic — toxic/adverse effects of a given dose over a period of time (one day, 21, 90, 270 days);

• Bioassay — dosage of drugs that exhibits effectivity/potency;

• Mutagenecity — genetic effects of the formulations;

• Heavy metals analysis — metal content and tolerable limits of the preparation;

• Dosage formulation — tablets, syrups, lotion ointment, etc.

• Clinical trials:

° Phase I — trials on 15 to 30 human subjects to determine the range of relatively safe dosage;

° Phase II — evaluation of the efficacy and determination of the most effective dose, including the disposition of the drug among 30 to 60 subjects;

° Phase III — confirmation and refinement of the formulation’s efficacy, safety and toxicity based on trials involving at least 200 subjects. Community participation is encouraged;

° Phase IV — though not strictly required by the Bureau of Food and Drugs (BFAD) on medicinal plants, the NIRPROMP still confirmed the drug efficacy on a broader range of subjects through the multi-center approach involving hospitals and medical centers for drug monitoring.

3. The pharmaceutical component — for the determination of the appropriate formulations for each plant/plant parts and the shelf-life qualities.

The technology transfer and utilization process

1. Technology transfer

To date, 102 plants have been scientifically validated for safety and efficacy. Ten of these plants have undergone or are still under different stages of development under Mission I. These are yerba buena, tsaang gubat, niyog-niyogan, bayabas, ulasimang bato, bawang, lagundi, sambong, akapulko and ampalaya. Studies on these plants have been completed — lagundi, sambong and akapulko.

The technology of the production of lagundi tablets (300 mg), sambong (250 mg), akapulko lotion and lagundi pediatric syrup was adopted by the Department of Health through its four regional herbal manufacturing plants in Davao, Cotabato, Tuguegarao and Tacloban.

Private sector transferees were Pascual Laboratories, Gruppo Medica and Lloyd Laboratories through a license agreement per product. Altermed, the subsidiary of Pascual Laboratories, is actively manufacturing and commercializing lagundi tablets (Ascof) and sambong tablets (Releaf) which bested 100 other products and inventions and winning silver medals at the 25th International Exhibition of Inventions, New Techniques and Products in Geneva, Switzerland in April 1997. Altermed is now earning millions of pesos from the sale of these products.

2. Technology utilization

Results of the NIRPROMP studies were documented in the following publications distributed to different communities, schools/colleges/universities, barangays, NGOs, medical centers, DOH, etc.

• Guidebook in the Proper Use of Medicinal Plants

• National Trainors’ Manual on the Use of Philippine Medicinal Plants

• Philippine Materia Medica

• Philippine National Formulary

• Brochures on the Use of Medicinal Plants

• Selection and Scientific Validation of Medicinal Plants for Primary Health Care

• Manual on Bioassay Procedures

• Monograph on Vitex Negundo (Lagundi)

• Agricultural Manual

The NIRPROMP Team conducted six months of technical manpower training programs and seminar/workshops to raise awareness of the country’s health and drug situation on the validated safety and efficacy of medicinal plants as alternate/complementary medicines.

Through NIRPROMP, the DepEd has encouraged the adaptation of the herbal medicine gardens in schools.

The NIRPROMP research results have been adopted in the development of the ASEAN Program on Herbal Medicine.

Above all, Executive Order 302 signed by President Arroyo on March 29, 2004 adopted the Philippine Pharmacopeia I as the official book of standards and reference for pharmaceutical products, which include crude plant drugs in the Philippines.

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Sources: Philippine Council for Health Research and Development (PCHRD), Department of Science and Technology UP Colleges of Medicine, Pharmacy and Agriculture, Institute of Chemistry Philippine Institute of Traditional and Alternative Health Care (PITAHC), Department of Health

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Pacita L. Zara, M.D., is a former executive director of the Philippine Council for Health Research and Development, Department of Science and Technology. E-mail her c/o [email protected].