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Ayurvedic Proprietary Medicine

This page contains brief details about the drug ayurvedic proprietary medicine, it’s indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Background and Date of Approval

The Drug and Cosmetic act 1940, section 3A and 3H describes criteria for marketing Ayurvedic proprietary medicines (APM). In that, section 3A is for the drugs/formulations mentioned in authoritative books of Ayurveda, e.g. Cyavanaprāśa. The section 3H is for those formulations containing ingredients which are mentioned in the formulae described in the authoritative books but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books with or without the use of Ayurvedic principles.

EXPERT ADVICE FOR Ayurvedic Proprietary Medicine

A question arises in my mind about the 3H. How one could call a formulation as an Ayurvedic which may or may not use Ayurvedic principles fully. Some companies use additional ingredients such as additives such color (Carmosin) and/or preservatives such as Benzalkonium chloride, Sodium methyl parabens, Phenyl ethyl alcohol, etc., to optimize their final formulation according less stringent regulatory guidelines so as to get marketing approval. Since both Ayurveda and modern bio science have well established principles of formulation, my objection is to the present approach viz. selecting main raw materials for Ayurvedic herbal and/or Herbomineral preparation from Ayurvedic database based on Ayurvedic properties and perhaps formulating it using modern pharmacognostic/pharmaceutical approach. How can a formulation made without understanding the basic differences in principles and philosophies of both systems of medicine be rationally called an APM?
Formulation of any medicament has to be done as per se t and validated protocol; any deviation in it may be responsible for the alteration resulting unwanted effects. Not only a chemical deviation but also others such as temperature, pressure etc., have an ability to change the physiochemical and/or pharmacological properties of a drug moiety. For instance, the coca butter the most suitable oleaginous base used for the formulation of the suppositories has many forms which are represented by α, β, βl and γ and their phase conversion is temperature based.