Para 6.4 of Schedule M-l needs to be revisited

Para 6.4 of Schedule M-l read with Rule 85-E (2) of Drugs and Cosmetics Act, 1940 & Rules framed there under which provides Good Manufacturing Practices and requirement of premise, plant and equipments for homoeopathic medicines as it appears contradictory to the general principal of homoeopathic and this provision of Para 6.4 is contradictory in itself also as it is applicable only for the compound formulations and not on single ingredient dilutions. Moreover it is contradictory in itself in exception part where highly poisonous material and toxins should not be below 6X potency is mentioned. Before the detailed discussion on this provision for ready reference of the readers Para 6.4 of Schedule M-l is reproduced as under:-
44Para 6.4 Formulation.- Compound formulation shall preferably be in liquid and solid forms and the potency of the ingredient shall be in detectable quantity preferably be in 3X expect in case of highly poisonous material and toxins which should not be below 6X. The ingredients shall be compatible to each other. Complete pharmacopoeial name of each ingredient shall be printed on the label along with composition.”
That Para 6.4 has contrary provisions contained in it by providing different and many fold less potency of ingredients for general ingredients and for toxin and poisonous substances when a general ingredients is not within the detectable limit below 3X potency how any poisonous or toxin ingredients can be in detectable limit above 6X potency.
Homoeopathic works as a general principle “like kills alike” and more the potency more the effective homoeopathy drug, therefore by putting a cap on the potency of the ingredient in formulation of homoeopathic putting a cap on effectiveness of drug means the formulations.
That govt., of India has allowed the import and marketing of those homoeopathic drugs in India manufactured by various foreign manufacturer of reputes and their homoeopathic formulation are not in conformity to the para.
Para 6.4 of Schedule M-1 needs to be revisited
Para 6.4 of Schedule M-l read with Rule 85-E (2) of Drugs and Cosmetics Act, 1940 & Rules framed th ere under which provides Good Manufacturing Practices and requirement of premise, plant and equipments for homoeopathic medicines as it appears contradictory to the general principal of homoeopathic and this provision of Para 6.4 is contradictory in itself also as it is applicable only for the compound formulations and not on single ingredient dilutions. Moreover it is contradictory in itself in exception part where highly poisonous material and toxins should not be below 6X potency is mentioned. Before the detailed discussion on this provision for ready reference of the readers Para 6.4 of Schedule M-l is reproduced as under:-
“Para 6.4 Formulation.- Compound formulation shall preferably be in liquid and solid forms and the potency of the ingredient shall be in detectable quantity preferably be in 3X expect in case of highly poisonous material and toxins which should not be below 6X. The ingredients shall be compatible to each other. Complete pharmacopoeia! name of each ingredient shall be printed on the label along with composition.”
That Para 6.4 has contrary provisions contained in it by providing different and many fold less potency of ingredients for general ingredients and for toxin and poisonous substances when a general ingredients is not within the detectable limit below 3X potency how any poisonous or toxin ingredients can be in detectable limit above 6X potency.
Homoeopathic works as a general principle a like kills alike” and more the potency more the effective homoeopathy drug, therefore by putting a cap on the potency of the ingredient in formulation of homoeopathic drug means putting a cap on effectiveness of the formulations.
That govt, of India has allowed the import and marketing of those homoeopathic drugs in India manufactured by various foreign manufacturer of reputes and their homoeopathic formulation are not in conformity to the Para.
6.4 and having formulations with ingredients more than 3X potency Allowing the imported homoeopathic formulations having ingredients more than 3X and are not detectable during analysis and prohibiting the domestic Indian homoeopathic drug manufacturers seems to be a clear violation of principle of equality.
Para 6.4 also states that “Potency of the ingredients shall be in detectable quantity” whereas detection of the potency of the ingredients always depends upon the quality and sensitiveness of analytical instruments used for detection of potency of ingredients. It is a known claim by the manufacturers and the practitioners about the homoeopathic drugs that more the potency of drug more it is effective. Therefore, we may not equate the homoeopathic drugs with allopathic drugs and the more potent hence more effective as claimed by homoeopaths should not be discouraged.
Para 6.4 is applicable only for the compound formulation and not on single ingredient dilutions, therefore, when the question of detection arises how two contrary provisions can be made by allowing the single ingredient dilutions even in official books like Homeopathic Pharmacopoeia of India permitting the ingredients much more than 3X potency. Whereas the same ingredient when used in compound formulation is not permitted having potency more than 3X giving reason not in detectable limit.
Therefore, Para 6.4 of Schedule M-l read with Rule 85-E (2) of Drugs and Cosmetics Act, 1940 & Rules framed there under which provides Good Manufacturing Practices and requirement of premise, plant and equipments for homoeopathic medicines needs to be revisited it needs to be revisited.
Narender Ahooja “Vivek Panchkula”

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