|Year : 2016 | Volume
| Issue : 1 | Page : 56-57
Is Redefining the Ayurvedic Proprietary Medicine Required?
Swapnil P Borse
From the Symbiosis School of Biomedical Sciences, Symbiosis International University, Lavale, Pune, Maharashtra, India
|Date of Web Publication||9-Dec-2016|
Swapnil P Borse
Symbiosis School of Biomedical Sciences, Symbiosis International University, Lavale, Pune - 412 115, Maharashtra
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Borse SP. Is Redefining the Ayurvedic Proprietary Medicine Required?. Ancient Sci Life 2016;36:56-7
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.
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. When melted and cooled it solidifies into different crystalline forms depending on temperature of melting, rate of cooling and size of mass. The β crystals are formed if melted below 36°C and cooled slowly. On the other hand, γ crystals are formed if melted above 36°C and cooled rapidly. This alter normal releasing pattern and thereof may alter Pharmacokinetic-Pharmacodynamic profile as well. There are many examples of such phase inversion and/or polymerization owing to alteration in temperature and/or pressure.
Ayurveda places high importance to the process of formulation. Ayurveda has very well explained the concept of bhāvanā and saṃskāra. Bhāvanā may be correlated with addition of other Ayurvedic ingredients while saṃskāra may be correlated to use of parameters such as temperature, pressure for instance, different ways of trituration. Ayurveda believes that even the pharmacological effects of final formulation may get altered with respective to time and other environmental factors owing to effect of bhāvanā and saṃskāra.
| Cross Talk between Ayurveda and Biomedicine|| |
Ayurveda and modern may both be saying the same in different languages with different philosophies and approaches but the drug remains a drug. Ultimately it is a rasāyana (~chemical) which is going to act through either drug receptor interaction or altering doṣas. Hence I think that if we want to integrate both systems of medicine then there is a need for integration at their principles and fundamental level. Therefore if we are going to formulate Ayurvedic proprietary medicine (APM), it should be formulated considering ayurvedic principles of formulation. In case if the drug approval requires addition of other ingredients such as additives, then these must be evaluated as per Ayurveda to understand the Ayurvedic properties of the final formulation. For instance, an approach discussed by Nanal et al. can be useful. They have studied the ayurvedic properties of non-Ayurvedic substances such as custard (not covered in the any ayurvedic book) and explain its use along with its properties as per ayurvedic philosophy. In addition to this, a dosing selection investigator and/or researcher may perform clinical trials to optimize the dose.
In addition to this all, I personally admire the opinion of Prof. Chaudhary as he feels that now at every juncture Ayurveda is on a journey of double edge. A simple ignorance or carelessness either way i.e. on doctrines or on experiments may harm it irreparably. Hence I request all integrative researchers and scientists to give their comments on this issue.
Author is thankful to Dr. Girish Tillu, and Dr. Angad Shripat for timely discussion.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Gaeg RA. Commercial's Manual on Drugs and Cosmetics. 3rd
ed. Delhi: Commercial's Law Publishers Pvt. Ltd.; 2005. p. 3, 4.
Langevelde AV, Malssen KV, Peschar R, Schenk H. Effect of temperature on recrystallization behavior of cocoa butter. J Am Oil Chem Soc 2001;78:919-25.
Sharma P. Dravyaguna Vignyan: Part II and III. Varanasi: The Chowkhamba Vidyabhawan; 1969. p. 586.
Nanal VM, Nanal RM. Evaluation of custard based on ayurvedic principles. Anc Sci Life 1992;12:267-70.
Chaudhary A. Clarion call on issues of Ayurveda: Our responses. J Ayurveda Integr Med 2013;4:133.