Image Credit: Freepik
Introduction
Homeopath selects a remedy for a patient after a thorough case taking, and prescribes it with confidence. If it does not give the desired result, it influences beside his reputation and practice, the name of homeopathy and Hahnemann. The selection may be right, but the remedy prescribed may not posses its therapeutic power. That is why Hahnemann directs physicians to judge the genuineness of medicines in Organon Aphorism 264 and 265.
The true physician must be provided with genuine medicines of unimpaired strength, so that he may be able to rely upon their therapeutic power; he must be able, himself, to judge of their genuineness.
-Aphorism 264, 5th & 6th edition of ‘Orgonon of Medicine’
It should be a matter of conscience with him to be thoroughly convinced in every case that the patient always takes the right medicine and therefore he must give the patient the correctly chosen medicine prepared, moreover, by himself.
-Aphorism 265, 5th & 6th edition of ‘Orgonon of Medicine’
At present environmental circumstances it is difficult for the physician himself to prepare medicines -as Hahnemann says- in dust and pollution free surrounding. Because it requires high technology and finance. Considering all these, government of India recently notified ‘Good Manufacturing Practices’ (GMP) for homeopathic pharmaceuticals. It describes location and surroundings, building, water quality, disposal of waste, health of workers, safety measures, container managements, required spaces and equipments, functions of quality division, collection of raw materials, manufacturing procedures, packing and labeling, expiry period and maintaining standard operating procedures (SOP).
Homeopathic remedies above 12C do not contain any molecule of the original drug substance, but contain the information transformed to the vehicle during potentisation. The vehicle as altered structure holds this information. Such dilutions are sensitive and can be affected by little stimulation like electromagnetic field or sunlight.
Medicines prepared under stringent GMP measures are with high quality. Since homeopathic medicines are highly diluted and no testing procedure has been developed so far for potentised dilution, GMP is mandatory. A holistic standardization procedure for production, storage and drug delivery assures the high quality in each stage. Cost difference is not much; it is calculated that the difference of a week’s dosage (1 dram pills) cost per patient will not exceed 33 paise. Saving very little money in this sense may affect the cure rate and homeopathy.
High quality dilution
Many factors involve in the brought up of a high quality dilution. Care is to be taken from the raw material itself. Selecting the right plant itself is difficult because they are from different species and varieties. The constituent of the plant also varies from species to species and soil to soil. Skill, knowledge and experience are needed to select a right plant. The techniques involved in the process are macroscopy, microscopy, thin layer chromatography, assay for constituents and phytochemical analysis. The part of the plant used is another important factor; the one that is used in the proving should be used. In case the flower and leaves are used, the proportion is important for the quality. Age of the plant also is important. Holarrhena antidysenterica, a plant less than 6 years old is not used.
In case of chemical based medicines the ratio of the elements in the compounds are important; e.g. Ferrum phosphoricum is not iron phosphate but it is Ferrousoferric phosphate, which contains about 47% iron. Back potencies are to be kept safely and it should not be affected by glass alkalinity, polluted environment, sunlight, electromagnetic field, etc.
Dust free and pollution free environment are maintained in the production area of GMP factories. The air-handling units with High Efficiency Particulate Air filters ensure this. Micron filters in the air handling system eliminate the micro-organisms. Workers have to use facemasks, headgears, gloves, aprons and shoe covers. Perfumes are not permitted. Health of the workers is taken care. Periodical medical check-ups are to be done. People with infection are not allowed in the production area. By maintaining these, the chances of contamination during the process of making dilution are almost eliminated. It reflects as successful results in patients.
The alcohol quality also influences the quality of dilution. Extra neutral alcohol is the purest form and free from the impurities like fusel oil, aldehydes and ketones. The glasses used for various purposes of packing are to be neutral. The alkalinity of glass plays a major role in the quality of the final product.
Products older than 5 years of manufacturing are not to be used. Alcohol evaporation, contamination and adverse storage are the factors, which can spoil the dilutions over 5 years. The Drug Rule recommends (as per recent amendment), 5 years expiry for all homeopathic preparations. Mechanical vibrators / potentisers should not to be used upto 1000C and bottles are to be changed at each stage as per Hahnemannian potentisation method recommended in the pharmacopoeia. Use of micron filters for filtration of air, solvents and tinctures will help free from microorganisms and other contaminants.
Dilutions are to be packed in not more than 100ml bottles. Drug rule also recommends this. Scientific reason behind this is the dilutions are made in dispensing alcohol (90% alcohol). The duration of usage and number of openings will be more if packed in 450/500ml bottles. Alcohol evaporates faster than water. So over a period the alcohol percentage will come down. As a result, dissolution of globules is faster, the therapeutic power may be lost and also chances of contamination are more.
Compromising with quality in garments, house utensils and other articles may not harm. The cost of treatment with good quality homeopathic medicine is much more cheaper than drugs. For the little difference in the cost going for substandard medicines from non-GMP factories makes no sense. When un-surety prevails the physician may not be able to rely upon the therapeutic power of prescribed remedy. If it does not work the practice will not be successful and the reputation of the doctor gets damaged. It ultimately affects homeopathy.