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

 

About Author:
Swati Manik
Department of Pharmacognosy,
I.S.F. College of Pharmacy, Moga, Punjab
swatimanik@yahoo.in

ABSTRACT:-
There is a great demand of the herbal drugs from both the developing as well as developed nations because of their efficacy, safety and lesser side effects as compared to synthetic molecules. These drugs also offer therapeutics for age-related disorders like memory loss, osteoporosis, immune disorders, etc. for which no modern medicine is available. It shows the promisingcontribution of herbal drugs in both economy and health concern, thus, it is ground enough to invest on their development.As the effectiveness and acceptability of the herbal products greatly depends upon its quality. The lack of standardization is the key factor due to that India despite of its rich traditional knowledge, heritage of herbal medicines and large biodiversity has a dismal share of the export to the world market. Therefore, the quality assurance of herbal drug/products is the need of an hour. Hence, standardization has become an essential component of the herbal drug/products that ensures the benefits of the herbal drugs.
Thus, by standardization of herbal drugs/products the Indian herbal market and even the export of herbal medicines will increase, making “India the Pharma Power House”.

REFERENCE ID: PHARMATUTOR-ART-1643

INTRODUCTION:-
“Health for all” is a dream and a goal which humanity at large shares and strives for, unfortunately, it has been proven without doubt that modern pharmaceuticals are and will remain out of reach for a large proportion of the human population for the near future. This has created an appreciation and a need for the use of other sources of human knowledge to provide common health benefits. Alternative and traditional medicines, largely herbal in nature, are now regarded as important but underutilized tools against disease.

Nature always stands as a golden mark to exemplify the outstanding phenomena of symbiosis. Natural products from plant, animal and minerals have been the basis of the treatment of human disease. The consumption of plant-based medicinesand other botanicals in the West has increased manifold in recent years. About two centuries ago, our medicinal practices were largely dominated by plant-based medicines.However, the medicinal use of herbs went into a rapid decline when more predictablesynthetic drugs were made commonly available. In contrast, many developing nations continued to benefitfrom the rich knowledge of medical herbalism. For example, Ayurvedic medicine in India, Kampo medicine in Japan, traditional Chinese medicine (TCM), and Unani medicine in the Middle East andsouth Asia are still used by majority of people.In the recent era of herbal renaissance, the demand of herbal medicines and other botanicals byWestern communities have been increasing steadily, particularly over the past two decades. Along with herbal medicines, other herbal products such as cosmetics, fragrances, teas, health foods, and nutraceuticals are equally popular and constitute a large proportion of global herbal business.

In olden times, in India vaidyas used to treat patients on individual basis, and prepare drug according to the requirement of the patient. But the scenario has changed now; herbal medicines are being manufactured on the large scale in Pharmaceutical units, where manufactures come across many problems such as the availability of good quality raw material, authentication of raw material, availability of standards, proper standardization methodology of single drugs and formulation, quality control parameters. The use of herbal medicine due to toxicity and side effects of allopathic medicines, has led to sudden increase in the number of herbal drug manufacturers [1].

India has a rich heritage of traditional medicine constituting with its different components like Ayurveda, Siddha, Unani, Homoeopathy and naturopathy. Traditional health care has been flourishing in this country for many centuries [2]. The growing use of botanicals by the public is forcing moves to evaluate the health claims of these agents and to develop standards of quality and manufacture. Most medications before being offered to Consumers undergo rigorous evidence-based Clinical testing; this is not necessarily true for Herbs, due to their long historical clinical use and reliable therapeutic efficacy. Various traditional medicine system, especially Indian system of medicine attracted the global attention, and many big pharmaceutical companies are using traditional medicine as an excellent pool for discovering natural bioactive compounds. With the growing need for safer drugs, attention has been drawn to their quality, efficacy and standards of the traditional Indian medicine [3, 4]. Each traditional system of medicines has their own method of standardization for assuring quality most in human linguistic terms. This method of evaluation has to be taken into consideration in standardization of herbal medicine/drugs [5].

The World Health Organisation (WHO) defined the Herbal drugs as “a finished labelled products that contain active ingredients such as aerial or underground parts of plant or other plant material or combinations thereof, whether in the crude state or as plant preparations”. [6]

Herbal drugs are classified as

  • Phytomedicines or phytopharmaceuticals sold as over the counter (OTC) products in modern dosage forms such as tablets, capsules & liquids for oral use
  • Dietary supplements containing herbal products, also called neutraceuticals available in modern dosage forms
  • Herbal medicines consisting of either crude, semi-processed or processed medicinal plants.

Some time herbs are combined with mineral preparations also. The herbs often exist in crude state and Ayurveda describes method of purification of toxic herbs.

Advantages of Herbal Medicine:-

  • They have long history of use and better patient tolerance as well as acceptance.
  • Medicinal plants have a renewable source, which is only hope for sustainable supplies of cheaper medicines for the world growing population.
  • Availability of medicinal plants is not a problem especially in developing countries like India having rich agro-climatic, cultural and ethnic biodiversity.
  • Prolong and apparently uneventful use of herbal medicines may offer testimony of their safety and efficacy.
  • Throughout the world, herbal medicine has provided many of the most potent medicines to the vast arsenal of drugs available to modern medicinal science, both in crude form and as a pure chemical upon which modern medicines are structured.

Limitations of Herbal Medicines:-

  • Ineffective in acute medical care
  • Inadequate standardization and lack of quality specifications
  • Lack of scientific data

Current and future status of Indian herbal medicines:-
India is sitting on a gold mine of well-recorded and well practiced knowledge of traditional herbal medicine. India is one of the 12-mega biodiversity centres having over 45,000 plant species. Its diversity is unmatched due to the presence of 16 different agro-climatic zones, 10 vegetative zones and 15 biotic provinces. The country has 15,000–18,000 flowering plants, 23,000 fungi, 2500 algae, 1600 lichens, 1800 bryophytes and 30 million micro-organisms [7]. India also has equivalent to 3/4 of its land exclusive economic zone in the ocean harbouring a large variety of flora and fauna, many of them with therapeutic properties. About 1500 plants with medicinal uses are mentioned in ancient texts and around 800 plants have been used in traditional medicine.

But, unlike China, India has not been able to capitalize on this herbal wealth by promoting its use in the developed world despite their renewed interest in herbal medicines.

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