GOVT.

AYURVEDIC COLLEGE PATIALA

DEPARTMENT OF RASA SHASHTRA

AND BHAISHJAYA KALAPANA

Session 2021-22

Submission to-
Dr. Pradeep Kapil
Dr. Abhishek
Submitted by-
Dr. Ravneet kaur chahal Dr. Rohit Parmar
 Introduction
 The preparation of medicine i.e. pharmacy is an integral part of this science, and developed from very basic
form. In ancient times, the preparation of medicine was part of the practising physicians function. 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 some past times ayurvedic practice has assumed
business proportions and the manufacture of ayurvedic drugs are on a commercial scale.
 In ancient text the quality parameters for raw drugs and finished products including compound formations
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 humanity.
 Example: latex collect in the morning, for good quality and quantity. Vidanda should be used after one year
so that the percentage of embelin will be stable and in more qauantity
 Another major problem is the fixation of dose according to present times.
 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 API & AFI would now enable the government to implement the Drug and Cosmetic
Act 1940 in respect of quality control for the ASU drug manufactures, distributed and sold in india.
 NEED OF STANDARDIZATION
Charak Samhita explains that a real expert in medicinal plant is the one who besides their nomenclature and identification is
also well versed in their applications i.e. their qualities, action and uses.
न नामज्ञानमात्रेण रूपज्ञानेन वा पुनः|
ओषधीनां परां प्राप्तिं कश्चिद्वेदितुमर्हति|| (च. स. सू.१/१२१)
• Moreover, global resurgence of interest in herbal drugs had led to the need of their mass production which perhaps was not
even contemplated by the traditional vaidyas who prepared and dispensed medicine on a personal and individual basis.
• Large scale production of medicinal plants products necessitated the availability of standards for maintaining and assuring
the quality and safety to attain the desired therapeutic effects.
• Standardization minimizes batch to batch variation, assure safety, efficacy, quality and acceptability of the poly herbal
formulations.
• A lot of Ayurvedic drugs which are available in the market do not have the actual ingredients may be due to non
identification/ false identification/ non availability of that drug
• Since one synonyms is allotted to many plants and many synonyms to one plant which lead to confusion in the actual
identification of the plant. E.G. GIRIJA for Shilajatu, Abhraka and Gairika.
• Standardization of the herbal formulation requires implementation of Good Manufacturing Practices (GMP).
 NEED OF STANDARDIZATION
• To resolve the problem of variation in the properties of the drugs due to different area, habitat, season.
Drugs collected from the road side contains deposition of the more toxic metal compared to cultivated
variety. Wide difference between the cultivated and wild variety of Ashwagandha. Similarly plants that
are collected from different habitat and season other then mentioned in our classics contains less active
chemical constituents.
• To maintain the quality and purity of drugs of herbal origin whole life cycle of a drug from cultivation,
collection, processing and development to manufacturing and marketing should be under strict vigilance
system. This is achieved only through standardization of various steps involved in drug development.
• In addition, study of various parameters such as pharmacodynamics , pharmacokinetics, dosage, stability,
safety, shelf life, toxicity, evaluation, chemical profiling of the herbal and rasa formulation is considered
essential.
• Globalization of Ayurveda is possible only by standardization.
 THE AYURVEDIC PHARMACOPOEIA

PHARMACOPEIA:
pharmakon + poi + ia
Pharmakon = A drug
Poi = make
Ia = A noun that combines all
so pharmacopeia means “ Drug making “
Description of each single drug or preparation included in a pharmacopoeia are called monographs.
 AYURVEDA PHARMACOPOEIA COMMITTEE
 APC was first functional unit at department of Ayush.
 Constitution of APC on 20 September 1962 by Government of India.
 Setting up of Drug standardization research for Ayurvedic drugs in April 2006, it was shifted under CCRAS.
 The Government of India introduced an amendment in 1964 to the Drug and Cosmetic Act 1940, to control to a
limited measure the ASU drugs.
 Formulary without standards will not useful. So 3 Drug Standardization Research Projects(DSRP) units at
Chennai, Jamnagar and Varanasi were established, which worked on developing preliminary standards on
Ayurvedic formulations.
 Compiled data from these units , a volume entitled “ Pharmacopoeia Standards for Ayurvedic Formulations”
holding standards for Ayurvedic 415 formulation were published in 1976. Revised edition in 1987 with 431
formulations.
 OFFICIAL AND ESSENTIAL PUBLICATIONS OF APC

Ayurvedic Formulary of India .

Ayurvedic Pharmacopoeia of India.
Atlas of Ayurvedic Pharmacopoeia Drugs.
CONTRIBUTING LABORATORIES & INSTITUTIONS

• 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
AYURVEDIC PHARMACOPOEIA OF INDIA
 AYURVEDIC PHARMACOPOEIA OF INDIA
PUBLICATIONS
• There are two parts of API. Part 1 contains 9 volumes (Single drugs) and part 2 contains four volumes
(Formulations).
AYURVEDIC PHARMACOPOEIA OF INDIA PART-1 CONTAINS TOTAL 645 MONOGRAPHS
S.No. VOLUME YEAR OF PUBLICATION NO. OF MONOGRAPH

1. API Part 1 vol 1 1986 80

2. API Part 1 vol 2 1999 78

3. API Part 1 vol 3 2001 100

4. API Part 1 vol 4 2004 68

5. API Part 1 vol 5 2006 92

6. API Part 1 vol 6 2008 101

7. API Part 1 vol 7 2008 21

(Minerals & Metals)
8. API Part 1 vol 8 2011 60
(Hydro-alcoholic & Water extracts)
9. API Part 1 vol 9 2016 45
(Hydro-alcoholic & Water extracts)
AYURVEDIC PHARMACOPOEIA OF INDIA PART- 2 CONTAINS 202 FORMULATIONS

S.NO. VOLUME YEAR OF NO.OF

PUBLICATION MONOGRAPH

1. API Part 2, vol 1 2007 50

2. API Part 2 vol 2 2008 51
3. API part 2 vol 3 2010 51
4. API Part 2 vol 4 2017 50

VOLUME YEAR OF NO.OF

PUBLICATION MONOGRAPH

Hindi Ed. API Part 2, vol 1 2011 50

Hindi Ed. API Part 2, vol 2 2011 51

Supporting Pharmacopoeial Publications of Ayurvedic
pharmacopeial drugs :
 Thin Layer Chromatographic (TLC) Atlas
 Macroscopy and Microscopy Atlas

VOLUME YEAR OF NO.OF

PUBLICATION MONOGRAPH

TLC Atlas API Drugs Part 2009 80

1, vol 1

TLC Atlas API Drugs Part 2016 99

1, vol 3
 VOLUME YEAR OF NO. OF
PUBLICATION MONOGRAPHS

Macroscopy and API drugs Part 1 2009 92

Microscopy Atlas vol 5

Macroscopy and API drugs Part 1 2011 80

Microscopy Atlas vol 1
 PARAMETERS OF STANDARDIZATION
1. Title
2. Name of the drug – in Sanskrit as mentioned in ayurvedic classics .
3. Introduction –parts , scientific name (Latin) with short description about it’s habitat, distribution and method of
collection.
4. Synonyms – in Sanskrit, Hindi , English and local language as described in ayurvedic classics.
5. Organoleptic characters- odor and taste
6. Mesh number
7. Weights and measures.
8. Identity, purity and physio-chemical parameters.
9. Pharmacognosy – microscopic, macroscopic.
10.Pharmacological aspects (properties &action)- Rasa ,Guna , Virya , vipaka and karma. Therapeutic use and
dosage.
11.Toxicological study:- heavy metals, microbiological, pesticides, radioactive.
 PHYSICAL PARAMETERS: -

• Moisture content
• Density
• Optical rotation
• Melting point
• Foreign organic matter
• Specific gravity
• Viscosity
• Refractive index
• Solubility
• Extractives.
 CHEMICAL PARAMETERS:-

• Chemical tests and assays.

• Identification and isolation of active constituents of drug.
• Quantitative chemical testing like saponification.
• Detection of adulteration
• Halphen’s test for cotton seed oil etc.
Acharya charak mentioned about the same in the treatise Charak Samhita Viman Sthan 8/87, under the heading - Drug
Evaluation-

“
तस्यापीयं परीक्षा- इदमेवम्प्रकृ त्यैवङ्गुणमेवम्प्रभावमस्मिन् देशे जातमस्मिन्नृतावेवं गृहीतमेवं निहितमेवमुपस्कृ तमनया च मात्रया युक्तमस्मिन् व्याधावेवंविधस्य पुरुषस्यैवतावन्तं दोषमपकर्षत्युपशमय
ति वा, यदन्यदपि चैवंविधं भेषजं भवेत्तच्चानेन विशेषेण युक्तमिति||८७|| ”

इदमेव प्रकृ ति = Nature of plant

एव गुण = Properties
एव प्रभाव = Action
अस्मिन देश जात = Habitat
अस्मिन नृतावेव गृहीतमेव = Time and mode of collection
निहितमेव = Storage
उपस्कृ तमनया च = Processing
मात्रा= Dosage
युक्तमस्मिन व्याधा = How to use
एवं विधस्य पुरूषस्येव = The Constitution of the patient
एतवन्तं दोषमपकर्षत्युपशमयति वा = The effect on disorders, whether eliminates it or pacifies it.
यदन्यदपि चैवविधं भेषजं भवेत्तच्चानेन विशेषेण युक्तमिति =any other drug of this type should have the same characters.

Using this protocol one can prepare a standard monograph which is most applicable for the practice of Ayurveda.
THE AYURVEDIC FORMULARY OF INDIA
 Scattered 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.
 THE AYURVEDIC FORMULARY OF INDIA

The ayurvedic formulary of india total 985 monographs are presented

Part Year of publishing Number of monographs

I 1978 revised in 2003 444

II 2000 191

III 2011 350

 E- book publications of AFI

AFI Number ofmonographs

Part- I & II 635

Part – I, vol I- V 418

Part – I, vol VI 101

Part –II, vol I 50

Part –II, vol II 51

 APPENDICES
Appendix- I
1. Samanya paribhasha
2. Kalpana paribhasha
3. Puta paribhasha
4. Yantra paribhasha
Appendix- II
5. Shodhana
6. Ashta shamskara of parada
Appendix- III
7. Therapeutic indices ( formula & disease wise)
Appendix- IV
8. Diseases/technical terms and English equivalents