Api & afi

Ayurvedic formulary of India and Ayurvedic Pharmacoepia of India- An Overview

1. By
Dr. Prajeesh Nath E N
Department of Rasashastra & Bhaishajya Kalpana
Amrita School of Ayurveda, Kollam.

2. 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.

3. 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.

4. 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

5. 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.

6. APC was first functional unit at department of Ayush.
Constitution of APC on 20
th
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.

7. 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)

8. Ayurvedic Formulary of India
Ayurvedic Pharmacopoeia of India
Atlas of Ayurvedic Pharmacopoeia Drugs

9. German Commission E Monographs
European Scientific Cooperative for phytotherapy (ESCOP)
The American Herbal Pharmacopoeia
WHO Monographs
USP Monographs

10. 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

11. 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

12. 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

13. 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

14. 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)

15. 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

16. 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

17. 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

18. 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

20. 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.

21. Ayurvedic Pharmacopoeia of India – Part 1
Volume Year of publishing Number of Monographs
I 1986 80
II 1999 78
III 2001 100
IV 2004 68
V 2006 92
VI 2008 101
VII 2008 21 (minerals & metals)
VIII 2011 60(Aq. & Hydroalcoholic
extracts)

22. Ayurvedic Pharmacopoeia of India – Part 2
(Formulations)
Volume Year of publishing Number of Monographs
I 2008 50
II 2009 51
III 2010 51
TLC Atlas of Ayurvedic Pharmacopoeial Drugs– Part 1
I 2009 80
Microscopy & Macroscopy Atlas of API Drugs -Part 1
I 2011 80
V 2009 92

23. 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 __ __

24. Title
Name of the Drugs
Synonyms
Description(Macroscopic & Microscopic)
Identity, Purity and Strength
1.Foreign matter
2.Total Ash
3.Acid-insoluble ash
4.Alcohol-soluble extractive
5.Water-soluble extractive

25. Assays and Tests
Constituents
Properties and action
Important formulations
Therapeutic uses
Dose

26. Appendix -1. Apparatus for tests and assays
Appendix 3 - Physical tests and detemination
Appendix - 2 .Tests and Determination
1.Determination of quantative data
2.Limit tests
3.Microbial Limit tests
4.Pesticide residue
5.Test for aflatoxins
6.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

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

29. 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.

30. Part Year of publishing Number of Monographs
I 1976 444
II 2000 192
III 2011 350

31. Part I Part II Part III
Asava& Arishta 37 3 17
Arka 4 2 14
Avaleha 32 7 20
Kwatha Choorna 9 25 30
Guggulu 12 2 7
Ghrita 44 4 -
Choorna 40 6 69
Taila 62 18 26
Dravaka 1 - -
Lavana & Kshara 13 - 2
Lepa 12 5 23
Vati & Gutika 35 14 26
Varti, Netrabindhu, Anjana8 2 2
Satva 1 - -

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

33. Apendix -I
1.Samanya Paribhasha
2.Kalpana Paribhasha
3.Puta Paribhasha
4.Yantra Paribhasha
Appendix -II
1.Shodhana
2.Ashta samskara of Parada
Appendix – III
1.Therapeutic Indices (Formula & Disease wise)
Appendix – IV
1.Diseases/Technical terms and english equivalents

34. 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