ABSTRACT –Quality control is a procedure for providing standard medicines to the patients. The quality of homoeopathic medicines can be checked by parameters given in H.P.I.. Quality assessment of homoeopathic medicines is an essential for better treatment of patient. In India the market value of homoeopathic medicines is growing day by day,Considering such large market value and widespread consumption of homoeopathic medicines the quality and safety assurance has become a major concern. . Potentised medicines are used by the practitioner on the basis of similimum but sometimes they do not get good results may be due to substandard of mother tincture. So, it is important to assure the quality of the homoeopathic medicine on which the physician relies for a successful practice.
INTRODUCTION–Homoeopathy is a therapeutic system of medicine which is based on the principle, “similiasimilibuscurentur” or let likes be treated be likes’.
Homoeopathy = homeos [similar] + pathos [suffering].
In India the quality of Homoeopathic medicines is under the control of Drug and Cosmetic Act 1940 and Rule 1945, a central legislation.
As Homoeopathic medicines are derived from different natural resources so standardisation and quality control of Homoeopathic mother tincture is very challenging. This work of standardization is done in Homoeopathic Pharmacopoeia Laboratory (HPL), Ghaziabad. It is one of the apex body established in 1975, for laying down standards and testing for identity, purity and for testing of Homoeopathic medicines. Under the rule 3A of the drug and cosmetic act, HPL also functions as central drug laboratory for the testing of Homoeopathic medicine. It also publishes the Homoeopathic Pharmacopoeia Of India (HPI).Standards of drugs worked out are released by the ministry of health & family welfare in the form of H.P.I. It is compulsory for the manufacturers to have GMP (Good Manufacturing Practices) certificate. GMP covers the guidelines of manufacturing process, premises, personnel, packaging and labelling apply to Homoeopathic medicines and failure to apply GMP may lead to quality and safety issues. GMP guidelines is given in Schedule M1,Rule 85-E(2),for drug manufacturing units to make sure the quality, efficacy and safety of their products. Manufacturing of mother tincture in our India under Rule 85 – B of Drug & Cosmetic Act 1940 and Rule1945.
Standardisation –The term “standardization” refers to the process of confirming a drug‟sidentity,quality,and purity throughout its entire life cycle,including self-life, storage, distribution, and using a variety of parameters. The drug standardization study is one of the most fundamental pre requisites to ensure genuineness/authenticity and lay down standards for the purity, safety and efficacy of raw drug The data generated through standardization studies not only provide a guideline for the manufacturing of homoeopathic drug but also provide quality drugs to the homoeopathic practitioners.
These are following types of stability which must should be considered for each and every drug –
1.Physical – Its appearance, palatability ,uniformity and dissolution .
2.Chemical – Each and every active ingredients retains its chemical integriety and labeled potency, within the specified limit.
3. Microbiological – The stability or resistsnce to microbial growth is retained according to the specified requirements.
4. Therapeutic –The therapeutic effects remains unchanged.
The ultimate aim of standardization is to produce homoeopathic drugs that are highly efficacious in; quality, safety and efficacy of the drug.
Different method of drug standardization-
A] Organoleptic evaluation – Its evaluation based on organ of senses e.g. Eyes (to see), nose (for order), tongue (to taste),skin (by touch) and includes the macroscopic appearance. The group of plant material is also considered –
1. Shape and Size.
2. External colour.
3. External markings.
5. Flowers and leaves.
6. Odour .
B] Physical evaluation –Its include chromatographic study of drugs.
C] Chemical evaluation – Chemical evaluation covers the isolation, identification, purification, characteristic determination of the drugs.
METHODS OF PREPARING HOMOEOPATHIC DRUGS: –
Dr.Hahnemann has given instructions regarding preparation of Homoeopathic mother tincture in Organon of Medicine in §267 and §271 including foot notes.
In OLD METHOD, the uniformity of drug strength was not maintained. So, to get uniform drug strength of 1/10, H.P.U.S introduced Newmethod. New method/ modern method excludes the previously adopted classification of medicinal substance and the formula of different classes for preparing Homoeopathic medicine.
In new method –By preparing mother tincture according to the new Method of preparation by maceration & percolation and comparing with the parameters with H.P.I.
In NEW METHOD, mother tinctures are prepared by two method Maceration and Percolation .H.P.I. also accepts the new method for preparation of mother tincture.
This process is used for the Gummy, mucilaginous and viscid drug substances which do not allow alcohol to permeate the mass easily . It tooks time 2 to 4 weeks.
This method is adopted for the extraction of dried drugs, dry vegetable substances and other organic substances. .It is the short process (24 hours).
Standard parameters for the quality control:-The following tests are conducted:-
1. Alcohol content:-Estimation of the alcohol content of mother tincture is a test for the strength of the mother tincture and an evaluation of the extraction process .Alcohol Content with in the normal range indicates that proportion of the drug and vehicle in the tincture as per pharmacopoeia guidelines and that the tincture has uniform drug strength.
2. Weight per ml:-The weight per ml of liquid is the weight in gm of one ml of a liquid when weighed in air 20 C.
3. pH value:-The pH value of an aqueous solution may be defined as the negative logarithm of the hydrogen ion concentration, express in grams per liter.(hydrogen ion concentration is measure of the extent of acidity or alkalinity of solution.
4. Total solid:-The Total Solid (e.g. chloride, calcium, sulphate, heavy metals) means residue ‟obtained when the prescribed amount of the preparation is dried to constant weight under the conditions specified next.
5. Thin layer chromatography(TLC):- TLC is one of the most specific method.
Conclusion –Success in homoeopathic prescribing is based upon the purity and quality of raw drug [crude drug] and finished product. A substandard drug will not produce desired results in sick individual.
In section number 264-265,5th and 6th edition of organon of medicine master Hahnemann said “the true physician must provide with genuine medicine of unimpaired strength, so that he may be able to rely upon their therapeutic power; he must able, himself of their genuineness.”
- Organon Of Medicine fifth and sixth edition combined Samuel Hahnemann Translated by R.E.Dudgeon,MD William Boericke,MD
- Dr.MandalB,Dr.MandalPrathaP.text book of homoeopathic pharmacy .
- Homoeopathic Pharmacopoeia of India.1sted.NewDelhi.
- Dr.SumitGoel .Art and Science of Homoeopathic Pharmacy.