Dr. Kalaratna, PG Scholar, A.L.N. Rao Memorial Ayurvedic Medical College, Koppa.
Dr. Milind J. Hukkeri, Reader, A.L.N. Rao Memorial Ayurvedic Medical College, Koppa.
Dr. Prashant Kumar Jha, Reader, A.L.N. Rao Memorial Ayurvedic Medical College, Koppa.
Standardization is the process of determining established norms and procedures for a procedure to act as a standard reference point for future test results. In the health sector standardization is vital as to provide the quality medicine and treatment all the times. It ensures that every batch of medicine has correct materials in appropriate amount to induce stable quality and therapeutic effect. The goal of reproducibility is achieved by the process of standardization. Quality encompasses all the properties of the final product which makes it optimal suitable for its intended use. This expression is generally used to describe all measures which are taken during the manufacturing process, from collecting and processing of the plant starting material, the concomitant quality control and to all the necessary steps to ensure a homogeneous and reproducible final product.
Standardization in Ayurveda
The concept of standardization and quality products were not unknown to Ayurveda as it is seen that in process of manufacturing of formulations. Many references are available in the scriptures which highlight the importance of safety profile and superior quality drug production. Utmost importance was given for SOPs right from the collection of raw drugs, manufacturing procedure till the storage of end product. While reviewing the instructions given with Ayurvedic classical literatures, following factors can be highlighted:
1. Place of origin and time of collection of raw material.
2. Specific part and quality of raw material (Graahya lakshanas).
3. Size and shape of furnaces.
4. Type and quantity of fuel used in the preparation.
5. Specification about the place of manufacturing (Rasashala).
6. Time and duration of process
7. Characteristic of finished material (Siddha lakshanas).
8. Shelf life etc.
They developed manufacturing process protocols according to the available resources and facilities in that time.
Parameters to check the quality of medicine were also set up and those were more of Organoleptic like, Bhasma pariksha, Siddhi lakshanas of Avaleha and Sneha, Samyak sandhana lakshanas etc. But advanced scientific scenario of present time and available scientific instruments for analysis of these prepared medicine find chances of error in testing of medicines by old methods.
The commercialization of Ayurvedic medicines going beyond the geographical bar has emphasized the SOPs and quality product. Other than this, the socio-economic changes, consumer preferences, changing lifestyles, etc. have also drawn focus on quality needs. Now physicians cannot prepare the medicines for their use in large scale due to lack of time and constrains in procuring raw drugs for the preparations. Hence, defining the basic level of active ingredients in a drug or developing its monograph, and even the quality of the final product, which is nothing but Standardization becomes important.
The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards organizations. Founded on February 23, 1947, the organization promulgates proprietary, industrial, and commercial standards worldwide. It has its headquarters in Geneva, Switzerland. Similarly different nations have their own regulatory authorities for this purpose. In India, traditional medicine is governed by the Drugs and Cosmetics Act, 1940 and the provisions of the Act are implemented by the state governments under the supervision of Government of India.
The chronological development of standardization is as follows:
· The concept of standardization originated near the turn of 19th century2.
· WHO in 1996 recommended the drug control agency to regulate the quality and safety profile of herbal products3.
· WHO in 1999 had given a detail protocol for the standardization of herbal drugs comprising of a single content.4
· In 2004 WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems.5
· In 2007 WHO Guidelines on good manufacturing practices (GMP) for herbal medicines.6
· In 2009 AYUSH department with collaboration with Quality Council of India introduced certification scheme for AYUSH drug products.7
· An European Union directive passed in 2004 erects “disproportionate” barriers against herbal remedies by requiring them to be “licensed” before they can be sold. It is called the Traditional Herbal Medicinal Products Directive (THMPD), Directive 2004/24/EC.8
· Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” The document was published in the Federal Register on Tuesday, July 5, 2011.9
In general, standardization determines and promulgates criteria to which objects or actions are expected to conform. It also refers to the establishment and adoption of guidelines for conduct. In global marketing, the term is used to describe the simplification of procurement and production to achieve economy. In reflex manner, standardization covers the following area:
1. Standardization of Raw materials
2. Standardization of operating procedures (SOPs) for manufacturing
3. Standardization of finished products
Uses of Standardization:
1. It enables innovation and act as a barrier to undesirable outcomes.
2. It ensures similar products i.e., quality products all the times
3. It avoids the extra investment of money or raw materials in terms of adjudging the quality every time, hence it is economical.
4. It is beneficial for both manufacturers and consumers.
5. With training and demonstration, it does not need always the highly skilled persons.
Number of other uses and benefits are there with standardization of medicines especially as they are directly related with human health.
1 Data and statistics. Available from: http://www.who.int/research/en.
2 Standardization. Available from: http://www.referenceforbusiness.com/encyclopedia /Sel-Str/Standardization.html#b#ixzz1rbocxDUV.
3 Quality Control Methods for Medicinal Plant Materials, WHO, Geneva, 1996. Available from: http://whqlibdoc.who.int/publications/1998/9241545100.pdf.
4 Pattanayak P, Behera M, Mohapatra P, Panda SK. Standardization and evaluation of laxative activity of a polyherbal formulation. Der Pharmacia Lettre 2011; 3(1): 276-286.
5 WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. Available from: www.who.int/medicinedocs/index/assoc/s7148e/s7148e.pdf.
6 Available from: http://www.who.int/medicines/areas/quality_safety/quality_ assurance/QualityAssurancePharm Vol2.pdf
7 Voluntary certificate scheme (VCS) for AYUSH products. Available from: http:// indianmedicine.nic.in/index3.asp?sslid=293&subsublinkid=96&lang=1 Last updated on:10/05/2011.
8 Available from: http://www.naturalnews.com/030873EUdirectivemedicinalherbs. html.
9 FDA Issues Long-Awaited Draft Guidance Document on New Dietary Ingredient Notifications. HerbalEGram. July 2011;8(7): July 2011; Food and Drug Administration. Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. Federal Register. July 5, 2011. Available from: http://www.accessdata.fda.gov/scripts/oc/ohrms /advdisplay.cfm.