ByDr. Prajeesh Nath E N

Department of Rasashastra & Bhaishajya KalpanaAmrita School of Ayurveda, Kollam.

Ayurveda is the most ancient science of life having a holistic health approach.

The preparation of medicines i.e. pharmacy is an integral part of this science, andevolved from a very rudimentary form. In ancient times, the preparation of medicine was part of the practising physician’s functions. The preparation of medicine was limited, selective and at personal level only.

Later on, this attitude changed and the profession was followed with a profit motive. The manufacture of Ayurvedic medicines also began on a larger scale. Since the last 40 years Ayurvedic practice has assumed business proportions and the manufacture of Ayurvedic drugs are on a commercial scale.

In ancient texts the quality parameters for raw drugs and finished products including compound formulations are well described and moreover this is in practices. It is mentioned how to collect the plant material, auspicious day and specific time with offering prayer to the plant that the material to be procured will be used for the welfare of the humanity.

Procurement of plant material in a particular time has a strong scientific base, like for collection of latex, it is advised to collect latex before sunrise to get good quality and quantity of material. Similarly after procurement of the material, use of plant material after a specific period of storage is described. For example

Vidanga (Embilia ribes, seeds) are advise are to be used after one year of its procurement as the percentage of embelin (active phyto-constituents ) will stable and quantity will be more compared to freshly procured sample. This eflects the quality assurance parameters.

The numbers of compound formulations are very huge, even more than 75,000, and of varied nature, using plant, mineral and animal sources. Another important characteristic feature of Ayurvedic compound formulations is that of their availability in different dosage forms.

At present very few generalized quality parameters are adopted. Some pharmaceutical firms may be having their in-house standard method of operations, and quality parameters for finished compound formulations. But there is no uniformity in the operating procedures

In the absence of official standards published by Government for statutory purposes, Ayurvedic Pharmaceutical Industry in particular has been experiencing several handicaps in implementing in house standards, as in any case, they need to comply with official standards. The AFI and API would now enable the Government to implement the Drugs and Cosmetic Act, 1940 in respect of quality control for the ASU drug manufacturers, distributed and sold in India

THE AYURVEDIC PHARMACOPEIA

•Greek word - pharmakopoiia having three words in it - pharmakon meaning ‘a drug’, the verb-stem poi meaning 'make' and abstract noun ending ia; cumulatively meaning 'drug-mak-ing'.

•Pharmacopoeia, literally means “drug-making’’.

• Descriptions of each single drugs or preparations included in a Pharmacopoeia are called monographs.

•They are the only officially recognised book for reference on standards of quality specifications of a synthetic and natural pharmaceutical drug and compilation of various ayurvedic pharmaceutical formulations.

APC was first functional unit at department of Ayush.

Constitution of APC on 20th September 1962 by Government of India.

Setting up of Drug Standardization Research for Ayuredic drugs In April 2006, it was shifted under Central Council for Research in

Ayurveda and Sidda.

The Government of India introduced an amendment in 1964 to the Drug and Cosmetics Act 1940, to control to a limited measure the Ayurvedic, Siddha and Unani drugs.

APC realize the importance of the issue and considered compilation of formulary as prelude. The first volume of API holds 444 formulations which was approved by APC for publication in 1969.

Formulary without standards will not useful.

Three Drug Standardization Research Project(DSRP) units at Chennai, Jamnagar and Varanasi were established, which worked on devolping preliminary standards on Ayurvedic formulations.

Compiled datas from these units , a volume entitled “Pharmacopoeia Standards for Ayurvedic Formulations” holding standards for 415 formulation were published in 1976(Revised edition in 1987 with 431 formulations)

Ayurvedic Formulary of India Ayurvedic Pharmacopoeia of India Atlas of Ayurvedic Pharmacopoeia Drugs

German Commission E Monographs

European Scientific Cooperative for phytotherapy (ESCOP)

The American Herbal Pharmacopoeia

WHO Monographs

USP Monographs

To prepare Ayurvedic Pharmacopoeia of India of single and compound drugs

To prescribe the working standards for compound Ayurvedic formulations including tests for identity, purity, strength and quality so as to ensure uniformity of the finished formulations

Keeping in view the time constraint, to identify such methods, procedures and plan of work as would enable to publish the formulary and standards of all commonly used drugs to be brought out in a phased manner

To prepare remaining parts of the official formulary of compound preparations from the classical texts including standardized composition of reputed institution

To develop and standardize methods of preparations, dosage form, toxicity profile etc

To develop quality standards, safety, efficacy profile of intermediates likes extracts of Ayurvedic raw drugs

To develop the quality standards, safety, efficacy profile of different parts of the plants; as well as to include new plants as Ayurvedic drugs

Any other matter relating to the quality standards, shelf life, identification, new formulations etc.

Targets, Focus of the Committee• To evolve standards for single drug and Ayurveda Formulations

as in official book• To prepare drafts SOP of Ayurvedic Formularies of India from

the classical texts and other authentic sources

University Institute of Pharmaceutical Sciences, Punjab University,Chandigarh

National Institute Pharmaceutical Education and Research(NIPER),Mohali

Captain Srinivasa Murty Drug Research Institute Ayurveda (CSMDRIA), Chennai

B. V. Patel, Pharmaceutical Education, & Research Development (PERD) Centre, Ahmadabad

National Botanical Research Institute, (Council of Scientific & Industrial Research), Lucknow

Ram Narayan Ruia College, Matunga, Mumbai

Established in 1978

To carry out research in Ayurveda and Sidda

Engrossed in developing safe, effective, appropriate and cost effective formulations for priority diseases

Financing of fundamental research projects of industry and institutions (35 labs)

Development of pharmacopoeial standards for single drugs and its formulations

Isolation of marker compounds of medicinal plants

Comparative phyto-chemical screening of roots and barks vs aerial parts

Preparation of Hindi version of API

Biological Activity studies of plant extracts

Extra Ayurvedic Pharmacopoeia of India

To identify methods & procedures for publication of standards of all commonly used formulations of AFI

Information on Ayurvedic Formulations regarding- Distinguishing characters-Method of preparation and dosage-Method of administration with Anupana-Toxicity

To develop quality standards, shelf life, identification, New formulations including safety efficacy of intermediates plant extracts

All other activities as mentioned in functions of APC

In 2010-Pharmacopoeia Laboratory for Indigenous Medicines (PLIM)

Autonomous body for Indian Medicine (Ayurveda, sidda, & Unani) to evolve the standards under the guidance of APC

To set and validate standards of drug(s)

To provide reference standards

To impart training to drug inspectors and analysts

To provide support APC

As a result I volume of API ,1986 with 80 monographs

The Part I of Ayurvedic pharmacopoeia of India consists of Vol-I to VIII comprising monographs prescribing standards for Ayurvedic single drugs of plant origin, which go into one or more formulations admitted to the Ayurvedic Formularies of India,.

The Part-II of the Ayurvedic Pharmacopoeia consists of official standards for 50 compound formulations present in the Ayurvedic Formulary.

Ayurvedic Pharmacopoeia of India – Part 1Volume Year of publishing Number of Monographs

I 1986 80II 1999 78III 2001 100IV 2004 68V 2006 92VI 2008 101VII 2008 21 (minerals & metals)VIII 2011 60(Aq. & Hydroalcoholic

extracts)

Ayurvedic Pharmacopoeia of India – Part 2 (Formulations)

Volume Year of publishing Number of Monographs

I 2008 50 II 2009 51III 2010 51

TLC Atlas of Ayurvedic Pharmacopoeial Drugs– Part 1

I 2009 80Microscopy & Macroscopy Atlas of API Drugs -Part

1I 2011 80V 2009 92

Kalpana Vol 1 (50) Vol 2(51) Vol 3(51)Arka __ __ 12

Avaleha 12 4 3

Churna 11 4 1

Ghrita 12 4 1

Guggulu 1 13 3

Vati 1 11

Asava& Arishta 24

Taila 6 1 20

Ksharasuta 1

Kshara (5)& Lavana(1) 6 __ __

Lepa(Darvi malahara) 1 __ __

Title Name of the Drugs Synonyms Description(Macroscopic & Microscopic) Identity, Purity and Strength1. Foreign matter2. Total Ash3. Acid-insoluble ash4. Alcohol-soluble extractive5. Water-soluble extractive

Assays and Tests Constituents Properties and action Important formulations Therapeutic uses Dose

Appendix -1. Apparatus for tests and assays Appendix 3 - Physical tests and detemination Appendix - 2 .Tests and Determination1. Determination of quantative data2. Limit tests3. Microbial Limit tests4. Pesticide residue5. Test for aflatoxins6. Gas chromatography Appendix – 4. Reagents and Solution Appendix – 5. Chemical Tests and Assays Appendix – 6. Ayurvedic Definition and Methods Appendix – 7. Weights and Measures Appendix – 8. Classical Ayurvedic References Appendix – 9. List of Single Drugs used in Formulation Appendix – 10. Bibliography

Title Definition Method of Preparation Description Identification – TLC Physico- chemical parameters Storage Therapeutic uses Dose

Scatterered information on various formulations in classical ayurvedic books was compiled in such a way.

List of single drugs of animal, mineral and plant origin has been prepared on the basis of names appeared in the formulations. Their official names and english equivalents are given for easy identification.

List of plant drugs has been edited as per botanical names of the plants appearing in the formulations for the convenience of the users, pharmacy experts and for the people who are not very much familiar with Ayurvedic terminology.

Part Year of publishing Number of Monographs

I 1976 444

II 2000 192

III 2011 350

Part I Part II Part IIIAsava& Arishta 37 3 17Arka 4 2 14Avaleha 32 7 20Kwatha Choorna 9 25 30Guggulu 12 2 7Ghrita 44 4 -Choorna 40 6 69Taila 62 18 26Dravaka 1 - -Lavana & Kshara 13 - 2Lepa 12 5 23Vati & Gutika 35 14 26Varti, Netrabindhu, Anjana

8 2 2

Satva 1 - -

Part I Part II Part IIIKupipakva rasayana 10 - -Parpati 5 2 1Pishti 4 2 1Bhasma 20 5 -Mandura 2 3 4Rasayoga 55 69 96Lauha 12 9 11Dhupa - - 1

Apendix -I1. Samanya Paribhasha2. Kalpana Paribhasha3. Puta Paribhasha4. Yantra ParibhashaAppendix -II1. Shodhana2. Ashta samskara of ParadaAppendix – III1. Therapeutic Indices (Formula & Disease wise)Appendix – IV1. Diseases/Technical terms and english equivalents

The Ayurvedic Pharmacopoeia is a book of Ayurveda monographs give sources, Physical properties, microscopic, macroscopic characters, identity tests, constituents, approved therapeutic uses, minimum and maximum doses, color photographs, chemical formula, and standards of quality of crude drugs including its formulations.

Also, The AFI and API would now enable the Government to implement the Drugs and Cosmetic Act, 1940 in respect of quality control for the ASU drug manufacturers, distributed and sold in India

The aim has been set standards for quality, efficacy and safety in order that the many traditional herbs and formulations meet legal requirement