Pharmaceutical Industry across the globe is making a shift in search of entities from synthetic active constituents towards substances which are of natural origin.

                Safety being prime concern, herbal drugs are back in vogue. Ayurvedic medicines known to treat & prevent various diseases since eons are now being re-validated for Safety, Efficacy & Quality.

                Regulatory bodies in India like Department of Ayush in association with Ayurvedic Pharmacopeia Committee (APC) has taken the initiative for standardization of crude herbal drug & published monographs in compendium of API Part-I (Vol. 1 to Vol. 8). Similar initiatives have been followed by various committees/ associations like AHPA (American Herbal Products Association), BP(British Pharmacopoeia), USP(United States Pharmacopoeia), IPC( Indian Pharmacopoeia committee), ICMR( Indian Council of Medical Research). BIS (Bureau of Indian Standards) is also working to issue monographs of Herbs.

                Whilst such monographs are in publication, the specifications of these drugs are not uniform across these compendia. It is known fact that there may be variations in the methods applied across the countries while analyzing these drugs.

                A case study of Ashwagandha (Withania somnifera) monographs was carried out (Table 1). Variation in parameters defined in each compendia and variation in specification can be noticed here.

With more and more monographs being added in various pharmacopeias, who should take the initiative to harmonize these standards?

An important observation is that within India there are atleast 4 different committee’s working simultaneously for publication of Monographs. Will it create a bias in the mind of user? 

Looking to our Heritage and Wisdom of Ayurvedic Medicines, major contribution should be ideally in the hands of agencies like Ayush & APC with collaborative technical support from IPC,ICMR &BIS. 

Please share your opinions and comments

Table 1: Ashwagandha (Root) (Withania somnifera) - Comparison of Monograph by 5 pharmacopoeias

1

2

3

4

5

6

7

#

Parameters

USP Draft monographs

BP 2009 Vol. III

API

IP 2007 Vol 3

AHP

   

Pg 3580

P I, V I, 10

Pg 2023

 

1

Definition

2

Medicinal part

3

Habitat

-

-

4

Synonym

-

-

5

Description : Macroscopic

6

Description : Microscopic

7

Foreign matter

NMT 2%

-

NMT 2%

NMT 2%

NMT 2%

8

Total Ash

NMT 7%

NMT 7%

NMT 7%

NMT 7%

NMT 7%

9

Acid Insoluble Ash

NMT 1%

NMT 1%

NMT 1%

NMT 1.2%

NMT 1%

10

Alcohol Soluble Extractive

NLT 10%

-

NLT 15%

NLT 10%

NLT 15%

11

Water Soluble Extractive

-

-

-

NLT 15%

-

12

Absence of Withania coagulans

-

-

-

-

13

TLC

-

√ (HPTLC)

14

Assay

Withanolide glycosides

Withanolide A (NLT 0.01%) & Withaferin A (NLT 0.01%) by HPLC method.

Alkaloids (NLT 0.2%) by Gravimetry method

Withanolide A (NLT 0.02%) & Withaferin A (NLT 0.02%) by HPLC method.

Alkaloids (NLT 0.2%) by Gravimetry method

15

Heavy metals

NMT 20 ppm

Pb - NMT 5 ppm     Hg - NMT 0.1 ppm,   Cd - NMT 1 ppm as per Eur Ph 6.8

Pb - NMT 10 ppm     Hg - NMT 1 ppm         As - NMT 3 ppm            Cd - NMT 0.3 ppm

NMT 20 ppm

 

16

Loss on drying

NMT 12%

NMT 12%

-

NMT 12%

NMT 10%

17

Total aerobic bacterial count

NMT 105 cfu/g

NMT 105 cfu/g

NMT 105 cfu/g

-

18

Total combined molds and yeasts count

NMT 103 cfu/g

NMT 104cfu/g

NMT 103 cfu/g

-

19

Bile-tolerant Gram-negative bacteria count

NMT 103 cfu/g

NMT 103 cfu/g

-

-

20

Salmonella species

Absent

Absent

Absent

Absent

21

Escherichia coli

Absent

Absent

Absent

Absent

22

Aflatoxins (B1, B2, G1, G2)

-

1200 ppb

-

-

23

Constituents

-

-

-

24

Properties and Action

-

-

-

25

Important formulations

-

-

-

26

Therapeutic uses

-

-

-

27

Dose

-

-

-

28

Packaging and Storage

-

 

29

Labeling

-

-

-

 
       

Note :

     

API : Ayurvedic Pharmacopoeia of India

     

IP : Indian Pharmacopoeia

     

USP : United States Pharmacopoeia

     

BP : British Pharmacopoeia

     

AHP: American Herbal Pharmacopoeia