STANDARDIZATION OF HERBAL DRUGS/PRODUCTS: BOON TO INDIAN PHARMA MARKET

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The basic requirements for gaining entry into developed countries market include: (i) Well-documented Ethno-botanical information, (ii) Medicinal plants free from pesticides, heavy metals, etc., (iii) Standardization, based on chemical and activity profile, and (iv) Safety and stability data. However, mode of action studies in animals and efficacy in human will also be supportive. Such scientifically generated data will project herbal medicine in a proper perspective and help in sustained global market.

The major traditional sector pharmas, namely Himalaya, Zandu, Dabur, Hamdard, Maharishi, etc. and modern sector pharmas, namely Ranbaxy, Lupin, Allembic, etc. are standardizing their herbal formulations by chromatography techniques like TLC/HPLC finger printing, etc. There are about 7000 firms in the small-scale sector manufacturing traditional medicines with or without standardization. However, in recent years very few of the pharmaceutical companies is standardizing the herbal medicines using active compounds as markers linked with confirmation of bioactivity of herbal drugs in experimental animal models [8].

The global trade of medicinal and related plant materials was estimated to be of the approximate value 62 billion US$ in 2001. China has been successful in acquiring the single largest share in this export market because of its well-designed national policy on the traditional Chinese medicine. Indian share of the world herbal trade is less than 1%. Even here, the export of herbal products is largely in the form of raw herbs with 2/3rd of the export basket comprising raw herbs. China’s share in world herbal market is US$ 6 billion while India’s share is only US$1 billion. India followed by China is the largest producer of medicinal plants, having more than 40% of global diversity so ideally it should have the second largest share, but the country lags far behind China owing to its unorganised trade system, lack of standardization of formulations and inadequate policy.

But still India’s export of formulations has reached 16,647.36 Crores till March 2008 and can increase manifold in the coming years if proper standardization techniques are followed [9].

The Indian market is growing at 15-20% per annum (Rs 7,000 million or $150 million) with world demand growing at 1% annually ($ 610 million), the size of export market for medicinal plants appears bigger than the Indian domestic market [10].

For Indian herbal industry, there is a huge export opportunity.

As the global market is big and expanding, the Indian herbal industry is focusing on exports. From a global perspective, critical challenges for herbal industry are:

· Regulatory concerns
o    Quality
o    Efficacy
o    Safety
o    Standardization

· Consumer perceptions

· Competition

Need of standardization:-
Traditional medicine implies knowledge and practice of herbal healing for the prevention, diagnosis, and elimination of physical, mental, or social imbalance [11]. The costs for health care are rising at an alarming rate throughout the world. At the same time, the world market for phyto-pharmaceuticals is growing steadily. Herbs, used as medicine, are also regulated under different categories throughout the world.

It is a common observation that people diagnosed with incurable chronic disease states such as diabetes, arthritis, and AIDS turned to herbal therapies for a sense of control and mental comfort from taking action [12]. Herbal product studies cannot be considered scientifically valid if the product tested has not been authenticated and characterized in order to ensure reproducibility in the manufacturing of the product. Several studies have indicated quantitative variations in marker constituents in herbal preparations. Moreover, many dangerous and lethal side effects have recently been reported, including direct toxic effects, allergic reactions, effects from contaminants, and interactions with drugs and other herbs. [13]

Recent surveys reported in the American news media indicated that a large percentage of the public would like to see products supported by clinical research. This means consumers are increasingly demanding products of known quality [14]. There is a strong demand and need to accelerate the research in phytomedicine. Standardized herbal products of consistent quality and containing well-defined constituents are required for reliable clinical trials and also to provide consistent beneficial therapeutic effects. Pharmacological properties of an herbal formulation depend on phytochemical constituents present therein. Development of authentic analytical methods which can reliably profile the phytochemical composition, including quantitative analyses of marker/bioactive compounds and other major constituents, is a major challenge to scientists. Without consistent quality of a phytochemical mixture, a consistent pharmacological effect is not expected. Standardization is the first step for the establishment of a consistent biological activity, a consistent chemical profile, or simply a quality assurance program for production and manufacturing [15].

Therefore, the European Union has defined three categories of herbal products:

  • Those containing constituents (single compounds or families of compounds) with known and experienced therapeutic activity that are deemed solely responsible for clinical efficacy.
  • Those containing chemically defined constituents possessing relevant pharmacological properties those are likely to contribute to the clinical efficacy.
  • Those in which no constituents have been identified as being responsible for the therapeutic activity [16].

A system to ensure that every packet of medicine that is being sold has the correct substances in the correct amount and will induce its therapeutic effect this is known as standardization. It is very important that a system of standardization is established for every plant medicine in the market because the scope for variation in different batches of medicine is enormous. Plant material may vary in its phytochemical content and therefore in its therapeutic effect according to different places of collection, with different times in a year for collection, with collection at the same time and places but in different years and with different environmental factors surrounding the cultivation of a particular medicinal plant. Adding to this variability is the fact that in herbal medicine several plants are used together in the same preparation. This means that there should be a quality control test for the entire preparation to ensure quality of the product.

World Health Organization (WHO) encourages, recommends and promotes traditional herbal remedies in national health care programmes because these drugs are easily available at low cost, safe and people have faith in them.

Alternative medicine is the need of the day, but improper authentication of herbs, adulterations by microorganism, pesticide residue has made standardization of herbal drug of primary importance. At present no official standard are available for the herbal preparation. Manufactures those who are doing some testing of their formulation, have fixed their own parameter, most of them are only preliminary in nature. It is very difficult to identify the presence of all the ingredients as claimed in a formulation. Hence, the first important task is to evolve such parameter by which the presence of the entire ingredient can be got identified various Chromatographic and Spectrophotometric methods and evaluation of physicochemical properties can be tried to evolve pattern for identifying the presence of different ingredient.

Herbal formulations are difficult to standardize as the plant is a biosynthetic laboratory for chemical compounds like glycosides, alkaloids etc. These exert physiological and therapeutic effect. So it will be very difficult if we want to estimate each and every ingredient in term of their chemical constituent. But if few major constituents having particular therapeutic action indicated in the labelled can be pinpointed then these constituents should be estimated quantitatively along with the other parameters through which presence of all ingredients can be confirmed. Combined, well coordinated efforts from scientific workers of different disciplines are required for this purpose.

It is the cardinal responsibility of the regulatory authorities to ensure that the consumers get the medication, which guarantee purity, safety, potency and efficacy and this duty can be discharged by rigidity following various standards of quality prescribed for raw materials and finished products in pharmacopoeias controlling manufacturing formulate through the use of formularies and manufacturing operation through statutory imposed “Good manufacturing practices”. All these procedure logically would be apply to all type of medication whether included in modern system of medicine or one of the traditional system such as Ayurvedic system of medicine.

Unfortunately the Ayurvedic pharmacopoeias and the formulary have been exempted from the standard attained by present day Modern medicine, which is continuously undergoing metabolic changes and improvements in the standard of purity, safety and efficacy. Thus maintaining the quality of Ayurvedic medication becomes the sole responsibility of the manufacture. The quality control of crude drugs and herbal formulations is of paramount importance in justifying their acceptability in modern system of medicine.

Furthermore, the constituents responsible for the claimed therapeutic effects are frequently unknown or only partly explained. These complex positions of quality aspects of herbal drugs are further complicated by the use of combination of herbal ingredients. It is not uncommon to have as many as five different herbal ingredients in one product. Thus batch to batch variation starts from the collection of raw material itself in the absence of any reference standard for identification. These variations multiply during storage and further processing.

The task of lying down standards for quality control of herbal crude and their formulation involves biological evaluation for a particular disease area, chemical profiling of the material and lying down specification for the finished product. Therefore, in case of herbal drugs and product, the word “Standardization” should encompass entire field of study from cultivation of medicinal plant to its clinical application.

Plant material and herbal remedies derived from them represent substantial portion of global market and in this respect internationally recognized guidelines for their quality assessment and quality control are necessary. In order to overcome certain inevitable shortcoming of the Pharmacopoeial monograph other quality control measures must be explored.

Key Parameters for Herbal drugs/products:-

  • Standardization
  • Quality evaluation

Standardization: -

  • Adjusting the herbal drug preparation to a defined content of a constituent or a group of substances with known therapeutic activity respectively by adding excipients or by mixing herbal drug extracts.
  • Also used to describe all measures which are taken during the manufacturing process and Quality Control leading to a reproducible quality [17]

Quality evaluation: - A systematic examination of the extent to which an entity (part or product) is capable of meeting specified requirements. The result of quality evaluation may be used for qualification, approval and registration or accreditation purposes. It is absolutely required for authenticity, purity, safety. It comprises of Quality Control and Quality Assurance [17]


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