Evaluation of Policy Governing Herbal Medicines Regulation and Its Implementation in Ethiopia

Figures & data

Table 1 Summary of Definition, Classification of HMs and Responsible DRAs in Respective Countries

SN.	Issue	Ethiopia	India	EU	Nigeria
1	Definition of HMPs	“Finished, labeled medicinal products that contain as active ingredients aerial or underground parts of plants, or other plant material, or combinations thereof, whether in the crude state or as plant preparations.”	“Medicinal products containing as bioactive substances exclusively are herbal drugs or herbal drug preparations.”	“Products which exclusively contain as active substances, either one or more herbal substances, one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations.”	“Finished medicinal product containing plant and their preparation presented with therapeutic or prophylactic claim and includes all preparations containing a plant material in part or wholly.”
2	Regulatory pathways	Proclamation 1112/2019.	D&C Act 1940 and Rules 1945.	Directive 2001/83/EC. Directive 2004/24/EC.	Decree No.15/1993.
3	Regulatory authorities	EFDA (Ethiopian Food and Drug Authority).	Ministry of AYUSH (Ayurveda, Yoga, Unani, Siddha & Homeopathy).	EMA (European Medicine Agency).	NAFDAC (National Agency for Food & Drug Administration & Control).

Table 2 Comparison of Requirements for Registration of Herbal Medicine Practices Ethiopia, India, EU, and Nigeria DRAs

S.No	Requirements in Registration of HMs	Ethiopia	India	European Union	Nigeria
1	Safety	√	√	√	√
	Botanical Identification	√	√	√	√
	Biological Information	√	√	√	X
	Toxicity Studies	√	√	√	√
	Microbial Tests	√	√	√	√
	Dosage Forms	√	√	√	√
2	Efficacy	√	√	√	√
	Clinical Data	√	√	√	√
	Standardization Report	√	√	√	X
3	Quality	√	√	√	√
	General Identity Tests	√	√	√	√
	Purity Test	√	√	√	√
	Qualitative Composition of AIs	√	√	√	√
	Quantitative Composition of AIs	√	√	√	√
	Specification	√	√	√	√
	Method of Analysis	√	√	√	√
	Stability Studies	√	√	√	X
	Certificate of Registration in the Country of Origin	√	√	√	√
	Good Manufacturing Practices	X	√	√	√
4	Labeling	√	√	√	√
	Name of the Product	√	√	√	√
	A Quantitative List of the AIs	√	√	√	√
	Dosage form	√	√	√	√
	Therapeutic Indication	X	√	√	√
	Mode of Administration	√	√	√	√
	Duration of Use	X	√	√	√
	Major Adverse Effects, if Any	X	√	√	√
	Contraindications	X	√	√	√
	Manufacturing Date	√	√	√	√
	Expiry Date	√	√	√	√
	Lot Number /Batch Number	√	√	√	√
	Name of Manufacturer	√	√	√	√
5	Packing	√	√	√	√
	Packing Specification	X	**	√	√

Notes: **Unknown if there is no supporting evidence whether the given parameters for the requirements needed during registration of HMs in the given DRAs of respective countries. Yes (√), no (x).

Abbreviation: AIs, active ingredients.

Figure 1 Demographic characteristics of study participants for cross-sectional survey (N=89).

Table 3 Contributing Factors for Weak Implementation of TM Regulation (N=89)

Variables					95% CI		AOR	95% CI
	Yes, n (%)	No, n (%)	P	COR	Lower	Upper		Lower	Upper
Absence of restriction on sale of HMs	64(72%)	25(28%)	0.40	1.485	0.587	3.756	–	–	–
Absence of scientific research data	47(53%)	42(47%)	0.18	1.772	0.762	4.122	1.364	0.536	3.475
Absence of expertise	61(68.5%)	28(31.5%)	0.47	0.714	0.287	1.773	–	–	–
Absence of mechanism to control HM advertising	42(47%)	47(53%)	0.18	0.564	0.243	1.312	0.596	0.230	1.546
Absence of mechanism to monitor safety practice of HM	38(43%)	51(57%)	0.64	1.22	0.524	2.850	–	–	–
Weak cooperation among concerned institutes	57(64%)	32(36%)	0.2	0.620	0.257	1.505	0.785	0.291	2.122
Absence of mechanism to monitor HM safety	66(74%)	23(26%)	0.01	0.246	0.082	0.741	0.227	0.071	0.728
Shortage of financial support for research	68(76%)	21(24%)	0.03	0.295	0.097	0.895	0.226	0.070	0.736

Figure 2 Opinion of expert on regulation of TM in Ethiopia.

Table 4 Demographic Data for Cross-Sectional Study Comprising Healers

Variables		N (%)
Sex	Male	22(100%)
	Female	–
Age (years)	21–40	5(22.7%)
	41–60	5(22.7%)
	>61	12(54.6%)
Experience (years)	10–20	13(59.1%)
	>20	9(40.9%)
Educational Status	Read and Write	10(45.6%)
	Secondary School	4(18.2%)
	Diploma & Above	8(36.4%)
Residency	Urban	22(100%)
	Rural	–
Number in Family	0–5	16(72.7%)
	6–10	5(22.8%)
	>10	1(4.5%)
Estimated Monthly Income	Unknown	13(59.1%)
	Varied	9(40.9%)

Table 5 Healers’ Responses on Legality and Patterns of Practice in HMs in AA (N=22)

Variables	N (%)
Is your enterprise/practice registered?
Yes	22(100%)
No	–
Which institution issued you the license?
Woreda Health Bureau	21(95.5%)
Regional Health Bureau	1(4.5%)
FMOH	–
Are all your herbal products registered?
Yes	1(4.5%)
No	21(95.5%)
How did you become a traditional medical practitioner?
Family business	17(77.3%)
From reputable TMPs	4(18.2%)
Hobby/divine call	–
Through research	1(4.5%)
How profitable do you find the TMP?
Very profitable	3(13.6%)
Profitable	13(59.1%)
Not profitable	6(27.3%)
Have you patented or formally appropriated any of your products?
Yes	8(36.4%)
No	14(63.6%)
Do you know the process to patent or formally appropriate any of your products?
Yes	11(50%)
No	11(50%)
Do you produce on a large scale for people to collect and retail for you?
Yes	–
No	22(100%)
Do you have some of your products in a pharmacy?
Yes	7(31.8%)
No	15(68.2%)
Have you worked with any recognized institution in Ethiopia before?
Yes	6(27.3%)
No	16(72.7%)
Are you concerned about possible commercialization of your innovations/innovative ideas without your knowledge or consent?
Yes	22(100%)
No	–
What main intellectual property mechanism do you think is most appropriate for traditional medical products?
Patent	14(63.7%)
Trade mark	7(31.8%)
Trade secrets	1(4.5%)
Geographical indications	–
How do you assess the IP policy regime in Ethiopia among TMPs?
High	5(22.7%)
Very high	–
Low	4(18.2%)
Very low	13(59.1%)