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HERBAL MEDICINES: OVERVIEW ON REGULATIONS IN INDIA AND EUROPE

Poster · April 2016

DOI: 10.13140/RG.2.2.27770.18888

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 HERBAL MEDICINES: OVERVIEW ON REGULATIONS IN INDIA AND EUROPE
Vijay Kumar*, Supreet, Amit Bhatia, Shruti Chopra
Department of Drug Regulatory Affairs, School of Pharmaceutical Sciences
Lovely Professional University, Phagwara-144 411, Punjab, India
Introduction
 Herbal medicines, also known as Phytomedicines or Botanical medicines, involves the
use of plant parts (leaves, roots, stem, flowers, and seeds) for medicinal/therapeutic
purpose.
 It is the oldest and still the most generally used system of medicine in the world at
present.
 The earliest recorded evidence of use of these medicine in Indian, Chinese, Egyptian,
Greek, Roman and Syrian texts dates back to about 5000 years.
 80% of the world population relies on herbal medicines as their primary healthcare
system.(1)
 As per World Health Organization (WHO) herbal medicines are of three types: Raw
plant materials, Processed plant materials and Medicinal herbal products.
 In India, herbal medicines are regulated by the Ministry of Ayurveda, Yoga and
Naturopathy, Unani, Siddha and Homoeopathy (AYUSH).
 Other departments such as National Medicinal Plants Board of India (NMPB) and
Quality Council of India (QCI) have the responsibility to maintain the quality, safety
and efficacy of the herbal medicines in India.(2)
 Regulatory provisions for Ayurveda, Unani, Siddha medicine are laid down in Drugs
and Cosmetics Act 1940 and Rules 1945.
 In Europe, herbal medicines are regulated by European Commission (EC) and Euro-
pean Medicines Agency (EMA).
 The Committee on Herbal Medicinal Products (HMPC) is the committee of EMA that
is responsible for giving scientific opinion on herbal medicines and constitution of Eu-
ropean Union herbal monographs.
 Regulations for Herbal medicines in Europe are described in the guidelines of the Di-
rective 2004/24/EC-Herbal Medicinal Products for Human use and Directive 2001/83/
EC-Medicinal Products for Human use. (3)
Objectives
 To study the regulatory guidelines for herbal medicines in India.
 To study the regulations given by European regulatory bodies for herbal medicines.
Methodology
 Guidelines given by AYUSH for herbal medicines in India were studied.
 Drugs and Cosmetics Act (D and C) 1940 and Rules 1945 regulations for herbal medi-
cines in India were studied.
 Guidelines given by EMA and EC for herbal medicines in Europe were studied.
 Role of HMPC in Europe for herbal medicines regulation were also studied.
Result and Discussion
 Herbal drugs are regulated under the Drug and Cosmetic Act (D and C) 1940 and
Rules 1945 in India.
 Rules relating to Ayurvedic, Siddha or Unani Drugs as per the Drugs and Cosmetics
Rules, 1945
 Part XVI: Describes the guidelines for the manufacture for sale of Ayurvedic
(including Siddha) or Unani drugs.
 Part XVII: Discusses labelling, packing and limit of alcohol in Ayur-
evedic (including Siddha) or Unani drugs.
 Part XVIII: Provide details of Government Analysts and Inspectors for Ayur-
evedic (including Siddha) or Unani drugs.
 In India, for registration and getting license for sale of the herbal drugs Form 24 D i.e.
Application for the grant or renewal of a licence to manufacture for sale of Ayurvedic/
Siddha or Unani drugs (4) is submitted to regulatory authorities.(Figure.1)
Figure 1: Form 24 D
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Result and Discussion (Continued...)
 In Europe, Traditional Herbal Directive 2004/24/EC given by the European
Parliament and Council on 31 March 2004 provides a simplified regulatory approval
process for Traditional Herbal Medicines.
 In Europe, to obtain Traditional Herbal Registration (THR) for herbal products, manufacturer’s
have to show evidence that the herbal medicinal product has been traditionally used to treat the
stated condition for a minimum of 30 years, 15 years of which must have been in the EU.
 Applicants have to follow a specific application procedure depending on the licence they need.
They can follow any one of the procedures mentioned below:
 Decentralised procedure : To mar ket the medicine in the Reference Member State and
other named EU countries.
 Mutual recognition procedure : Already have a national licence in one or more EU
countries but want to market it in others also.
 National procedure : To mar ket a medicine only in the single member state e.g. in Ger -
many.
 Centralised procedure : To mar ket cer tain types of medicines throughout the EU.
 Applicant has to include scientific evidence, in the application , indicating the safety, quality and
traditional use of the herbal product (Figure.2). This includes:
 A technical dossier covering the quality of herbal ingredients in the electronic Common Tech-
nical Document (eCTD) format for traditional herbal medicines.
 review of safety, by a registered doctor or pharmacist, with help of an expert report that should
contain details regarding the clinical and non-clinical safety areas.
 Application is submitted using electronic Common Technical Document (eCTD) format.Figure.3
Figure 2: Traditional herbal medicines registration
application Form Figure 3: Herbal medicine CTD Triangle
Conclusion
 In India, herbal medicines are regulated by the provisions of Drug and Cosmetic act 1940 and
rules 1945 and regulations given by AYUSH. Clinical trials that involve the use of herbal medi-
cines are required to follow AYUSH Good Clinical Practice Guidelines released on 28 March
2013.
 In Europe, the Committee on Herbal Medicinal Products (HMPC) was established in accordance
with Regulation (EC) No 726/2004 and Directive 2004/24/EC, which introduced a simplified reg-
istration procedure for traditional herbal medicinal products in EU Member States.
References
1. Herbal medicine [Internet]. University of Maryland Medical Center. [cited 1 April 2016]. Available from: http://umm.edu/health/
medical/altmed/treatment/herbal-medicine.
2. Ministry of AYUSH [Internet]. Indianmedicine.nic.in. [cited 28 March 2016]. Available from: http://www.indianmedicine.nic.in/
index.asp.
3. European Medicines Agency - Human regulatory - Herbal medicinal products [Internet]. Ema.europa.eu. [cited 16 April 2016].
Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/
general_content_000208.jsp&mid=WC0b01ac05800240cf.
4. http://www.aponline.gov.in/Quick%20Links/Departments/Health,%20Medical%20and%20Family%20Welfare/
Commissionerate%20of%20Indian%20Medicines%20and%20Homeopathy/FORMS/Renewal%20of%20Licence%20to%
20Manufacture%20for%20Sale%20of%20Ayurveda%20or%20Siddha%20or%20Unani%20Drugs(Form%2024D).pdf
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