Globally, herbal medicines have been considered an important alternative to modern allopathic medicine. Herbal medicines have been used by the humanity since time immemorial for various healthcare needs. Around 80% of the population of developing countries uses herbal medicines for treatment of various diseases. India is one of the largest producers of medicinal herbs and is called as botanical garden of the world. There is unmet medical needs for the discovery and development of phytopharmaceutical drugs.Although the herbal medicines are very popular in the society, only few medicinal herbs have been scientifically evaluated for their potential in medical treatment. In most countries, the herbal drugs are poorly regulated and are often neither registered nor controlled by the health authorities. The regulatory requirements for phytopharmaceuticals were notified by the Ministry of Health and Family Welfare, Government of India, which include the scientific data on quality, safety, and efficacy of an herbal drug on similar lines to synthetic, chemical moieties. Phytopharmaceutical drug is defined as purified and standardized fraction with defined minimum four bio-active or phytochemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation, or prevention of any disease or disorder but does not include administration by parenteral route. For phytopharmaceutical drug, there is a lot of stress on identification, authentication, and source of the plant used for extraction, fractionation, stability etc.
Mission and Goals:
Monograph Development: With the ever-increasing use of herbal medicines and the global expansion of the herbal medicines market, quality and safety has become a major concern for the health of the people. The quality of herbal medicines has a direct impact on their safety and efficacy. Thus, to regulate the quality standards, various identification and quantification procedures are mentioned in herbal monographs of Indian Pharmacopoeia.
The herbal drug monographs in IP include crude herbs, processed herbs, herbal materials, herbal preparations and finished herbal products that contain as active ingredients, the parts of plants, or plant materials, or combinations thereof. The specific monograph of IP of a herb details the Title and Synonym if any, Definition, Limits of active ingredient/Marker compounds, Description, Category, Identification, Chemical Tests, Assay of the marker constituents, Contaminants, Specific Tests, Storage conditions etc. Monographs are included in IP based on documented quality specifications and suggestions/feedback from the stakeholders. IPC received appreciation from different stakeholders in the field of herbal drugs till date, IPC has published 150 herbal monographs and 15 herbal monographs are in pipeline for the next edition of IP-2018. There will be nearly 10% rise in their number per year. These monographs included in IP have received wide acceptance globally and some of these monographs now appear in pharmacopoeias of other nations with or without further changes. In view of this IPC has also received an observer status in EDQM and in EP.
IPRS Development: The next important objective of Phytopharmaceutical wing is to develop novel BRS (Botanical reference substances) and PRS (phytochemical reference substances). The BRS and PRS demands are likely to be significantly augmented with respect to the expansion of herbal pharmaceuticals in upcoming years. Botanical Reference Substance is a standard whose botanical identity and genuineness has been well established to both genus and species level. Because BRS and PRS enable quality control personnel and scientists to confirm the authenticity of botanical samples through macroscopic, microscopic, HPTLC, or other laboratory methods of analyses, these materials are a necessity for laboratory testing of all botanical species.
Skill Development: Analytical training is another important key aspect of phytopharmaceutical division. In this regard different training was conducted to Government analyst, Pharmacy students, Research scholars, and foreign delegates on evaluation of physiochemical parameters and assay of Herbals Drugs by HPLC, HPTLC and GC. Industry specific diploma/certificate courses are proposed to targeting Under-graduates, Graduates, Post-graduates etc. in various domains. A short duration (3 months or 6 months) industry specific diploma/certificate course may be initiated in near future for the academic and industrial being.
Drug Testing: Analysis of New Drug Samples (NDS) and survey samples received from the stakeholder and regulatory authority, which involves the identification of specific marker, heavy metal, adulterant and other qualitative and quantitative parameters.
IP Awareness: Sensitization of the “Stakeholders” about the significance of herbal monographs in IP by means of conducting workshop/ seminar/ conferences as well as awareness programme about the Herbal Manual and BRS/PRS.
Advance level R&D lab: In near future, an advanced level natural products/phyto-pharmaceuticals laboratory may be established. The laboratory will involve the identification, characterization, and standardization, synthesis of PRS and pharmacological evaluation of herbal drug or samples. This laboratory was utilized as a platform for the discovery and development of PRS as well as discovery of novel herbal molecules, which can be exploiting for the herbal drug development. This state of art laboratory should be on international level and one of the India’s best natural product laboratory with preeminent human resources persons of this area.
DNA bar coding: Molecular identification of herbal drugs by means of DNA Bar-coding. DNA bar coding has become a vital new tool for taxonomists who are charged with the inventory and management of the Earth’s immense and changing biodiversity. Plant DNA barcodes will prove extremely useful for numerous applications such as ecological forensics, identification of traded materials, undertaking identifications where there is a shortage of taxonomic expertise available, and assisting species discovery in some plant groups.
Collaborated Project: Analytical, stability and pharmacological research projects with respect to novel herbal drug candidate can mutually be explored with herbal manufactures or research organization
Microscopic and Macroscopic identification of herbal drug
Chromatographic fingerprinting: HPLC, HPTLC, IR, GC, Mass etc.
Assay by UV, GC, HPLC and HPTLC
Estimation of Extractable matter
Estimation of Total Ash, Acid Insoluble Ash and water Soluble Ash Values
Estimation of Loss of Drying
Estimation of Swelling Index
Estimation of Refractive Index
Estimation of Flash Value
Estimation of Relative Density
Estimation of Optical Rotation
Estimation of Refractive Index
Estimation of Acid and Soap Value
Estimation of Bitterness Value
Estimation of Contaminates and Adulterants
Estimation of Foreign Organic Matter
Estimation of Heavy Metals
Microbial load testing
Other Monograph specific evaluations
Semi automatic HPTLC (ATS5, CAMAG)
HPLC gradient mode with auto sampler, PDA detector (Agilent)
Microbalance (up to 6 decimal digit)
Inverted Microscope with fluorescent filter (Nikon)
Rotavapor (Rotatory Evaporator)
Temp. controlled Water Bath with shaker
Distilled water Assembly
Gel electrophoresis system
Vertical deep refrigerator (-80º C )
PCR Thermal Cycler
Chemical Fume hood
Dr. Jai Prakash, Senior Principal Scientific Officer
Dr. Shashi Bhushan, Senior Scientific Officer
Ms Ritu Tiwari, Technical Associate