Though Ayurveda is the oldest and purest system of medicine known to humanity, the herbal healthcare segment consists of an assortment of unorganised players. The products manufactured by the unorganised players lack quality and purity, resulting in the end consumer receiving sub-standard Ayurvedic products.
The pre-requisite to enter and succeed in the herbal healthcare segment is a strong R&D backing to create innovative healthcare products. A state-of-the-art R&D forms the driving force in delivering high quality products to meet consumer demands across the world. The challenge is to be able to identify this requirement and direct efforts and investments in developing cutting edge research and development.
Unlike allopathy, where the molecule structure does not vary, there could be a vast differentiation in the herb depending on the place, season and soil it is grown in. Every single herb needs to be quality-checked to assertain that it conforms to the quality requirements and delivers the properties consistently.
Developing and manufacturing high quality Ayurvedic products is an extremely complicated process which requires full time attention. Quality control is a term that refers to the process involved in maintaining the quality or validity of a product. Regardless of the form of herbal preparation, quality control plays a vital role in maintaining the quality of the final product. Without quality control, there is no assurance that the herb contained in the bottle is the same as what is stated on the label. The widespread disregard for quality control in herbal products has tarnished the reputation of many herbal preparations. Therefore there is a need for proper identification of plants by authenticated technological analysis.
Good manufacturing practices in Ayurveda requires a consolidated effort in co-coordinating various elements of setting up a viable Ayurvedic manufacturing practice. Some of the important factors to be taken into account are:
- Prior approval and license from the Drug Controller authorities for manufacturing
- Location and surroundings, where the factory building for the manufacture of Ayurvedic medicines should be so situated to avoid contamination from open sewage, or any factory which produces disagreable or obnoxious odour or fumes or excessive soot, dust or smoke.
- The premises used for manufacturing, processing, packaging and labelling should conform to prescribed quality standards. Adequate space should be allotted to allow orderly and logical placement of equipment and materials to avoid the risk of a mix-up between different drugs or components and also to control the possibility of cross contamination by other drugs. Care should be taken to avoid the risk of omission of any manufacturing or control step.
Raw material & Finished products - Cleaning, segregation and storage of raw materials in quarantine and in rodent and insect-free areas. Packaging materials such as bottles, jars, capsules should be stored properly.
Finished goods after being packaged should be stored in an area marked "quarantine". Water supply is another aspect that cannot be ignored, considering the significance of water used in Ayurveda. The water used in manufacturing should be pure and of potable quality.
Hygiene requirements at manufacturing premise: Health clothing, sanitation and hygiene of workers also need to be taken care of. The uniform should also include cloth or synthetic covering for hands, feet and head wherever required. Adequate facilities for personal cleanliness such as clean towels, soap and scrubbing brushes is also imperative.
Adoption of adequate Quality Control measures: Quality assurance holds the prime responsibility of generating systems and procedures, their control, maintenance of GMP qualifications, handling of product related complaints, training and audits.
Engineering and Maintenance: Utilities like water, steam, compressed air, electricity, waste treatment, machinery maintenance, troubleshooting and calibration, come under the purview of engineering section. A detailed programme on preventive maintenance of each part of the equipment should be prepared and executed.
Documentation - Methodologies and procedures for reference and inspection.
- (The author is Executive Director, Research & Development, The Himalaya Drug Company, Bangalore),