This document discusses the regulation of herbal drugs in India. It begins by providing background on traditional Indian medicine systems like Ayurveda, Siddha, Unani, Naturopathy and Homeopathy. It then explains that herbal drugs are regulated under the Drug and Cosmetic Act of 1940 and Rules of 1945 in India. The Department of AYUSH is the regulatory authority that issues manufacturing licenses and enforces good manufacturing practices. The document outlines the application process for licenses, facility requirements, and clinical trial guidelines for herbal drugs. It also discusses issues like intellectual property protection of traditional knowledge and the growth of the herbal drug industry in India.

1. Regulation of Herbal Drugs
Presented By:
Shaista Ahmed
M.Sc. Clinical Research
2nd Semester
Jamia Hamdard

2. INTRODUCTION
 The use of plants for healing purposes predates recorded history and forms the origin
of much of modern medicine.Medicinal plants based traditional systems of medicines
are playing important role in providing health care to large section of population,
especially in developing countries. Indian Systems of Medicine are among the well
known global traditional systems of medicine.
 Most of the effective drugs were plant-based example aspirin (from willow
bark),quinine(from cinchona bark) and morphine(from the opium poppy).The
development of drugs from plant continues with drug companies engaged in large
scale pharmacologic screening of herbs.
 India has the unique distinction of having five recognized systems of medicine in this
category. They are-Ayurveda, Siddha, Unani, Naturopathy and Homoeopathy.

3. What are Herbal Drugs?
 Herbal Medicines are plant-derived materials or products with
therapeutic or other human health benefits which contain either raw or
processed ingredients from one or more plants.

4. Advantages of Herbal Drugs:
 They do not have negative side effects.
 They are very effective as compared to synthetic cosmetics.
 Easily available in large variety and quantity.
 Easily manufacture and cheap in cost.

5. Ayurveda
 The ancient Indian medical system also known as Ayurveda is based on ancient
writing that rely on “natural” and holistic approach to physical and mental health.
Ayurveda medicine is one of the world’s oldest medical system and remains one
of the traditional health care systems.
According to the World Health Organization about 70-80% of the world
populations rely on nonconventional medicines mainly of herbal sources in their
healthcare.
The comprehensive knowledge of the basic ideologies of Ayurveda is poorly
acceptable scientifically due to lack of evidence.

6. Unani
 Unani Medicine can be characterized by the works of its practitioners or hakims who
relied on natural healing based on principles of harmony and balance , uniting the
physical , mental and spiritual domain.
A traditional system of healing and health maintenance observed in south asia . The
origins of unani medicine are found in the doctrines of the ancient Greek physicians
Hippocrates and Galen
The treatments for chronic ailments and diseases of skin, liver, musculo-skeletal and
reproductive systems, immunological and lifestyle disorders have been found to be
highly effective and acceptable.

7.  Hakim Abdul Majeed made valuable contribution in unani medicine .He established
Hamdard Laboratories in 1906 ,it is a Unani pharmaceutical company in india ,Delhi .It
was established and became a waqf (non-profitable trust) in 1948. After the sad demise
of Hakeem Abdul Majeed his son Hakeem Abdul Hameed(1908-1999) tried his best to
bring unani system of medicine on modern scientific lines
 Some of its most popular products include Sharbat Rooh Afza, Safi, Roghan Badam
Shirin, Sualin, Joshina and Cinkara. It is associated with Hamdard Foundation, a
charitable educational trust.
Hakim Abdul Hameed

8. Naturopathy
(Art of natural healing)
A system of alternative medicine based on the theory that diseases can be successfully
treated without the use of drugs, by techniques such as control of diet, exercise, and
massage.
Naturopathy cures patients suffering from chronic ailments in comparatively less time than
any other form of medicine.
Naturopathic doctors treat their patients holistically i.e. taking into consideration their
individual biochemistry, bio mechanics and emotional predispositions.
Some important treatments of naturopathy are: Mud pack, Mud Bath, Spinal Bath,, Steam
Bath, Sun Bath, Magnet Therapy, Acupuncture, Acupressure, Physiotherapy

9. Siddha
Siddha medicine is one of the oldest traditional systems of medicine practiced in southern
part of India.
 Siddhar Agasthyar is considered as the founding father of this medical system and there
are 18 prominent siddhars who are the main contributors to this system of medicine.
 It has holistic approach and covers physical, psychological, social and spiritual well being
of an individual. Siddha medicines use Mooligai (herbs), Thathu (minerals) and Jeeva
(animal products) as their sources.
 Diagnosis of disease in siddha is made on the basis of Envagaithervu (Eight parameters),
of which nadi (pulse reading) is given special importance. It helps to find out the
imbalanced or predominating kuttram (humor).

10. Homeopathy
The word ‘Homeopathy’ is derived from two Greek words hómoios (similar) and páthos
(suffering).
Homeopathy is a distinct medical specialty being practiced across the world. It is a
recognized medical system in India through the Homeopathy Central Council Act, 1973.
The system has blended well into the ethos and traditions of the country that it has been
recognized as one of the national systems of medicine.
Homeopathic remedies are used by the public for viral diseases, allergic conditions, skin
disorders , various women and children diseases, hormonal disorders, pain and palliative
care, infertility ,as an adjunct/ adjuvant in Cancer, COPD, Diabetes and its complications.
In preventive care, Homeopathic medicines are used on a unique concept of Genus
epidemicus.

11. REGULATION IN INDIA
Herbal drugs are regulated under the Drug and Cosmetic Act ( D and C) 1940 and Rules
1945 in india , where regulatory provisions for Ayurveda,Unani,Siddha medicines are
clearly laid down.
 India has made GMP mandatory for manufacturing of Ayurvedic, Siddha and Unani
Medicines by incorporation of revised Schedule T in the year of 2003.
 Department of AYUSH is the regulatory authority and mandate that any manufacturing
or marketing of herbal drugs have to be done after obtaining manufacturing license .

12. AYUSH REGULATES
Department of AYUSH, ICMR and CSIR work together to achieve safe,
effective AYUSH products for the identified diseases and to develop new drugs.
AYUSH objectives are to control drug quality, laying down pharmacopoeial
standards, overseeing working of Pharmacopoeial Laboratory of Indian Medicines
(PLIM), partnership with the Quality Council of India (QCI) and to oversee
functioning of Indian Medicine Pharmaceutical Company Limited (IMPCL).
 AYUSH also controls enforcement of Good Manufacturing Practices (GMP),
setting up of common facilities following the Cluster approach and implementing
the scheme for Drug Quality Control.

13. New Regulatory guidelines by AYUSH
GAPs-Good Agriculture Practice . To promote the agriculture practice of herbal
drugs.
GACPs-Good Agriculture collection practice . For cultivation and collection of
herbal drugs.
GAFCPs-Good Agriculture and field collection practice . For better field selection
and harvesting

14. Herbal Process in India

15. Application for license to manufacture Drugs
An application for the grant or renewal of a license to manufacture for sale any
Ayurvedic,siddha,unani drug shall be made in Form 24-D to the license authority
along with fee of rupees one thousand.

16. Form of Licence to manufacture Drugs
Subject to the conditions of rule 157 being fulfilled,a license to manufacture for
sale any Ayurvedic,Siddha or unani drugs shall be issued in Form 25-D.The
license will be issued within a period of 3 months from date of receipt of the
application.

17. RULE 157
The manufacture of drug shall be carried out in condition mentioned in Schedule T
The manufacturing of drugs shall be conducted under the supervision of competent
technical staff consisting atleast one person.
The competent technical staff to direct and manufacture of ayurvedic drugs shall have
qualifications in Ayurveda as if siddha drugs and unani drugs have qualifications in
siddha or unani.

18. Schedule T, Drugs and Cosmetics Act
Schedule T for Good Manufacturing practice:
To manufacture good quality Ayurvedic, Siddha and Unani medicines Good
Manufacturing practices have been made mandatory by incorporation of revised
Schedule T in the year of 2003 (Govt. of India, 2005 ). Important features of Schedule T
are as follows:
i)Raw materials to be used in manufacture of medicines must be authentic, of prescribed
quality and free from contamination.
ii)Manufacturing process is as prescribed to maintain the standard.
iii)Adequate quality control measures to be adopted.
iv)Drugs released for sale shall be of acceptable quality.

19. A form of loan licence to manufacture drugs
A loan license to manufacture for sale of any drug shall be issued in form 25-E in
which state government may approve in thus behalf

20. Pradhan Mantri Jan Arogya Yojna
• This is a flagship scheme of the indian governments’s National Health Policy
which aims to provide free health coverage at the secondary and tertiary level to
its bottom 40% poor and vulnerable population.
• It offers a health cover to nearly 10.74 crore poor families.
• The Ayush Ministry has proposed inclusion of 19 Ayurvedic,Yoga,unani,siddha
and Homeopathy treatment packages in the cashless health insurance scheme PM-
JAY.
• This collaboration address the untapped potential of integration of AYUSH system
with modern medicine.

21. Schedules For Herbal Drugs In CDSCO
SCHEDULE E-List of poisonous substances under the Ayurvedic, siddha and
unani system of medicine.
SCHEDULE T-Under Schedule T of the drugs and cosmetics act 1940 the
government has made it mandatory for all manufacturing units to adhere to GMP
SCHEDULE Q-No cosmetics shall contain Dyes,Colours and Pigments.

22. IPR ISSUES of herbal drugs
Growing awareness of Ayurvedic medicines and formulations has led to several conflicts
with western pharmaceutical companies who are taking the lead from Ayurvedic
medicines and patenting them in their own name . By patenting our own herbs we can
protect Indian Intellectual Property .So to protect India has established a central authority
that is “National Biodiversity Authority” to monitor and control foreign access to Indian
biological resources including traditional medicines.
India’s patent laws with the Amendment Act of 2005 which contain provision for
mandatory disclosure of source and geographical origin of the biological materials used
in the invention while applying for Patent.
Development of database called Traditional Knowledge Digital library(TKDL), a
collaboration project of (CSIR) (AYUSH) to protect Indian traditional medicinal
knowledge and prevent its misappropriation at International Patent Offices.

23. Clinical trial phases
Phase I studies may not be necessary.
Need for testing its toxicity in animals has been considerably reduced.
Toxicity study may not be needed for phase-II trial unless reports suggesting
toxicity/herbal preparation is to be used for more than 3months.
Larger multi centric phase-III trial is subsequently planned based on results of phase-II
study.
These trials have also got to be approved by appropriate scientific and ethical
committee.

24. Regulatory Requirements for Clinical
Trials of Herbal Drugs
The procedures laid down by the office of the DCGI for allopathic drugs should
be followed for all traditional and herbal products to enter into clinical trials for
any therapeutic condition.
Co-investigators of the expert group are from the associations of physicians from
the concerned system for designing and evaluating the study.

25. Statics of MARKETS
Increased interest had significally contributed to the economic growth of the
Medicinal plant sector.
The global market potential of Aloe vera used to treat burns and added to skin
cream and cosmetics was estimated in the billions of dollars.
70% of export from the herbal sector consists largely of raw materials and is
estimated to be Rs 10 billion per annum.
It is estimated that nearly 960 plant species are used by the indian herbal
industry,and the turnover of the industry is more than Rs 80 billion.
One startup name Sparsh healthcare and wellness completely focusing on AYUSH
products for the treatment of patients.

26. FUTURE PRESPECTIVE
 Promotion of AYUSH education with emphasis on technical education in
AYUSH.
 Popularization and promotion of indian system of medicine in foreign
countries.
 Elaborate guidelines on quality control of herbal medicines.
 Develop reference standard for market-based analysis for all the plants used in
medicinal preparations.
 Awareness regarding GAP,GACP,GSP among growers and manufactures.
 Development of unified protocols , defined timelines and specific guidelines
defining the meeting with regulators.
 Financial assistance.

27. REFERENCES
1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3868382/
2. Guidelines for inspection of GMP compliance by AYUSH
3. https://www.google.com/search?q=regulation+of+herbal+medicine+in+india&o
q=regulation+of+herb&aqs=chrome.1.0l2j69i57j0l2.10302j0j4&client=ms-
android-oppo&sourceid=chrome-mobile&ie=UTF-8

28. Thank you