AN OVERVIEW ON THE HOMEOPATHY REGULATIONS IN INDIA AND US

1. AN OVERVIEW ON HOMEOPATHY
AND ITS REGULATIONS IN INDIA, US
1
Presented By
Jaya Prakash V,
Department of Regulatory affairs,
Reg no: 218311.

2. INTRODUCTION
• Homeopathy, the popular alternative
medicine is proposed by Samuel
Christian Hahemann.
• The word homeopathy was coined by
the German physician Samuel
Hahnemann in 1807.
• In India, homeopathy was introduced
around 1810 by Frenchman John
Hoingberger.

3. BACKGROUND
• At present, homeopathy is the third most popular method of
medical treatment in India, after Allopathy and Ayurveda.
• The Homoeopathy Central Council Act 1973
• In 1978, a Central Council for Research in Homoeopathy was
established.
• Homeopathy comes under Ministry of Health and Family
Welfare, Department of AYUSH.

4. • The market size for homeopathy medicines in India is currently
over Rs 1,000 crore, which has been growing by 15-20 per cent
annually.
• The Indian government has written standards for Good
Manufacturing Practices in homeopathy, and there are more
than 600 makers of drugs using these methods.
• A considerable amount of homeopathic drugs are now imported
from Germany.

5. THE PRINCIPLES BEHIND HOMEOPATHIC
MEDICINE
Homeopathy is based on three principles
1. The Law of Similars
2. The Law of Proving
3. The Law of Potentization

6. INDIAN REGULATIONS
• Homoeopathic medicines are covered under the provisions of
Drugs & Cosmetic Act, 1940 and the Rules made there
under1945
• Some Important Provisions are:
• Standards of Homoeopathic medicines to be complied for
manufacture, for sale, distribution or import are defined under
Second Schedule of the Drugs and Cosmetics Act.

7. • Minimum requirement for good manufacturing are included in
Schedule M-1.
• Under Section 26-a, Central Government can cancel licence of
manufacturing a drug, if therapeutic claims are not genuine.
• Procedures for labelling and packing of Homoeopathic
medicines are covered under Rule 32 a, Rule 106 a and 106 b.

8. • Licensing authority for issue of licence for Homoeopathic
medicines lies with the State Government as per Rule 67 a and
85 b.
• Homoeopathic Pharmacopoeia Laboratory, Ghaziabad is to
function as Central Drugs Laboratory w.r.t. Homoeopathic
drugs, under section 6 of the act under sub-rule 7 of rule 3-a.

9. HOMOEOPATHIC PHARMACOPOEIA OF
INDIA
• Homoeopathic Pharmacopoeia of India (HPI) is the official
book of standards of Homeopathic medicine in terms of
Schedule-II of the Drugs and Cosmetics Act, l940 and Rules,
l945.
• The Indian manufacturers are legally bound to manufacture
Homoeopathic medicines as per standards and methodology
given in the Homoeopathic Pharmacopoeia of India.

10. • If the standards of some drugs are not included in the
Homoeopathic Pharmacopoeia of India, manufacturers are free to
undertake manufacturing as per any recognised Pharmacopoeia
of the other countries.

11. • The HPI is prepared by the Homeopathic Pharmacopeia
Committee (HPC) constituted by the Government of India.
• To prepare Pharmacopoeia of Homoeopathic drugs whose
therapeutic usefulness have been proved on the lines of the
American, German and British Homoeopathic Pharmacopoeias.

12. US REGULATIONS
• Natural Medicines, classified as drugs under FDCA since 1938.
• Observed to work according to ‘Principle of Similars; Like
‘cures’ like.

13. FD&C Act
• The Federal Food, Drug, and Cosmetic Act of 1938 recognized
homeopathic preparations as drugs.
• Homeopathic remedies are regulated by FDA, which regulates
manufacturing and other standards mainly through The
Homœopathic Pharmacopœia of the United States (HPUS)
• Homeopathic drugs must be tested for scope of effect, and
manufactured and labeled according to the Federal FD&C Act
and the HPUS before they are considered official homeopathic
drugs.

14. • Many homeopathic drugs can be sold "over-the-counter“
• some are classified as prescription-only under all
circumstances, and some are classified as prescription-only in
various low dilutions.
• As with all drugs, the labeling requirements are important, as
that is one of the primary ways the FDA can regulate drugs.
• Homeopathic pharmaceutical techniques are not
technologically complicated, and the drugs are generally
considered to be biologically safe.

15. FDA MAKES SIGNIFICANT EXEMPTIONS
• They are not required to submit new drug applications to the
FDA.
• They are exempt from "finished product testing for identity and
strength".
• They may contain much higher amounts of alcohol than other
drugs, which may contain "no more than 10 percent.

16. • On 15 November 2016, FTC declared that homeopathic
products cannot include claims of effectiveness without
"competent and reliable scientific evidence."
• If no such evidence exists, they must state this fact clearly
on their labeling, and the agency said failure to do so
would be considered a violation of the FTC Act.

17. Type of
entity
Applicable
legislation
Is there pre
market
approval
Are there
labelling
guidelines?
Are there
good
manufacturin
g practices?
Are claims
on the
label?
Allopathic
drugs
Food , Drug and
cosmetics act
Some products:
new drug
application;
others have a
drug
monograph
Yes: 21CFR
part 201
Yes: 21CFR
parts 210 & 211
Required
Homeopathi
c drugs
Food , drug and
cosmetics act
Official drugs
have drug
monographs
Yes: 21CFR
part 201, FDA
compliance
policy guide
400.400
Yes: 21CFR
parts 210 & 211
Required

18. HPCUS ROLES
 HPCUS has Four Important Functions focus on Safety.
 Monograph Approval
 Pharmacy Practices and Procedures
 Technical data production for drug standards and controls
 Establishment of safe minimum potencies appropriate to Rx,
OTC and external use.

19. Present state of Homeopathic Pharmacopeia
• India - Homeopathic Pharmacopeia of India (HPI)(10
Volumes) (1971-2016)
• USA - Homeopathic Pharmacopeia of the United States
(HPUS) (American Institute of Homoeopath, 1897) ( Revision
2016)

20. STATUS IN ROW
• Homeopathy is fairly common in some countries while being
uncommon in others.
• In some countries, there are no specific legal regulations
concerning the use of homeopathy.
• Homeopathic preparations are not effective for treating any
condition, Outside of the alternative medicine community.
• Scientists have long considered homeopathy a sham or
a pseudoscience, and the mainstream medical community
regards it as quackery.

21. • Europe
• Belgium
• France
• Germany
• Italy
• Netherlands
• United Kingdom
• Switzerland
• Australia
• North America
• Canada
• Mexico
• South America
• Middle East and Asia
• Middle East
• South Africa
• Nigeria

22. CHALLENGES
The inherent challenges which Homoeopathy has been facing are:
• High quality clinical trials and verifications.
• There is a need of extensive research based upon individualised
treatment planning in Homoeopathy.
• Global guidelines for clinical research.
• Funding and resource related challenges.

23. CONCLUSION
• If a science exists there exist routes to prove it. Research studies
must be taken on a larger sample size at multi centric levels to
better understand Homoeopathy.
• Evidenced based medicine standards must be amended and
made mandatory at every level of Homoeopathic practices, be it
individual, clinical, hospital, Institutional, or research level.

24. REFERENCES
• https://www.business-standard.com/article/news-ians/boiron-
expands-its-range-of-homeopathy-medicines-in-india-
118100400862_1.html
• https://asia.nikkei.com/Business/Technology/Homeopathy-
India-s-traditional-system-of-medicine
• www.homeopathyeurope.org/publications/guidelines/homeopa
thic-provings
• www.ccrhindia.org/drugproving.asp

25. THANK YOU