Herbal medicines are popular because of experience and the abundant availability of plants in India due to its varied climatic zones. India has around 45,000 species of plants, out of which 15,000–20,000 plants have proven medicinal value.

1. Quality, Safety and Legislation of Herbal Products
Presented by
Ch. S S N D Balakrishna, M.Pharm
Roll.no: 219303
Department Of Regulatory Affairs
Shri Vishnu College Of Pharmacy (SVCP)

2. Introduction
What is herb?
Any plant with leaves, seeds, or flowers
used for flavouring, food, medicine, or
perfume.
➢Ancient Indian, Chinese and Egyptian
writings describe medicinal uses of plants

4. 2,500 years ago Hippocrates the father of medicine used only food and
herbs. It is best known for the sayings;
“Let food be your medicine and let medicine be your food”
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.

5. ➢Herbal medicinal product manufactured and marketed as Ayurveda, Siddha, Unani
etc. in India are in practice since ancient times
➢The Ministry of AYUSH (Ayurvedic, Yoga and Naturopathy, Unani, Siddha and
Homeopathy) was formed in 2014 to ensure the optimal development and
propagation of AYUSH systems of health care
➢A herbal medicinal product is now being accepted as health care alternative
worldwide and is used as both preventive and curative for various types of
ailments
➢Herbal products are licensed under Ayurveda / Siddha and Unani drugs, as patent
or proprietary medicines

6. Quality Of Herbal Products
Quality
Quality can be defined as the status of a drug that is determined by
identity, purity, content, and other physical, or biological properties,
or by the manufacturing processes.
Quality control of herbal drugs
• Quality control is the term that involves in processes involve in
maintaining the quality and validity of the manufactured products
• In general quality control is based on three important
pharmacopoeial definition
• Identification
• Purity
• Assay

7. ➢ Good manufacturing practice must be in place at all stages of production from
gathering the herbs in the wild, or growing them in fields, to manufacturing
the final herbal product
➢ It includes determining the composition of the herbal, material, good handling
during processing and formulation, preventing contamination, proper storage
and process control
➢ An important benefit of registration under the AYUSH is the safeguarding of
patients health by implementing stringent manufacturing and quality control
requirements

8. Parameters of quality control of herbal drugs
➢Macroscopic examination
➢Microscopic examination
➢Determination of ash value
➢Determination of foreign matter
➢Determination of heavy metals
➢Determination of pesticide residue
➢Determination of microbial contaminants

9. Safety Of Herbal Products
❖In the case of improper use however, medicinal products of natural origin may
also be dangerous
❖Herbal products can present health threat in various ways:
➢Poisoning due to long term use
➢Poisoning due to overdose
➢Poisoning with poisonous plant mixed into herbal preparations by mistake
➢Plants causing allergy
➢Plants causing interactions

10. Some medicinal plants contain small amount of toxic substances that are harmful
to us when they are used for too long.
The most common are the so called pyrrolizidine alkaloids found in
Coltsfoot (tussilago farfara), butterber (petasites hybridus), various
ragworts (senecio sp,) comfrey (Symphytum officinale), and some
others. They cause liver impairment and possibly cancer.
Wormwood (artimesia absinthium), contains besides aromatic and bitter
substances also a toxic substance “Thujon.” It is poorly dissolves in
water, so it is safe to drink as tea. Regular consumption of thujon
containing alcoholic preparation is however dangerous.

11. Another example of a plant that can be used for a long time is “Alder
buckthorn (frangula alnus).” Its bark is effective laxative, but only for short
term use. With its prolonged use, patients lose minerals, especially
potassium, which is harmful.

12. Safety Data
The requirement for submission of safety data is applicable for products
which are not official in current editions of pharmacopoeia and for herbal
medicines which are not listed in the current WHO Monographs on Selected
Medicinal Plants.
➢ For products of long-term traditional use: Documentary evidence of
safety should be submitted
➢ For foreign products where there is no dicumentary evidence of safety
in long-term use: toxicological studies proving safety are necessary,
and should be submitted in the dossier
➢ Non clinical studies

13. Legislation of Herbal Products
• Dept. of AYUSH, IMCC(Central Council of Indian Medicine) Act,
Research Councils like (ICMR & CSIR), and Drug & Cosmetic Act 1940
regulates herbal medicines in India
• They must follow the DCGI’s Regulations. (Drug Controller General of
India)
• In 1st amendment of D & C Act Rules 2008: Introduced Schedule TA for
record of utilization of raw material by herbal drugs
• In 2nd amendment of D & C Act Rules 2008: They permitted the use of
excipients in the herbal formulations

14. ➢Department of AYUSH controls product licensing, composition, formulation and
ensures manufacturing of products, labelling, packing, quality as per Schedule “T”
for good manufacturing practice (GMP) and monitors export of Ayurveda, Unani
and Siddha products
➢Section 33-EEB of the drugs and cosmetics act describes the regulations for the
manufacture and sale of ASU drugs , the act has set some standards related to the
hygenic conditions, factory premises, prohibition of manufacture and sale of certain
drugs and penalties for contravention of this act
➢Section 33-EED of the drugs and cosmetics act prescribes certain powers of the
central government can prohibit the manufacture, sale and distribution of ASU drugs
which involve any risk to humans or animals o such drugs does not have therapeutic
value as claimed by the manufacturer or any misbranded and spurious drugs

15. ➢As prescribed under section 33-I of the drugs and cosmetics act any person himself,
on his behalf is engaged in the manufacture, sale and distribution of prohibited
ASU drugs, penalty has been fixed as per the following
✓Any Asu drugs which is deemed to be adulterated or manufactured without a
valid licence shall be punishable upto one year imprisonment and with fine upto
1000 rupees
✓Any ASU drug which is deemed to be spurious shall be punishable with
imprisonment upto 1-3 years and with fine upto 5000 rupees
✓Any ASU drug which contravenes any other provison of the act shall be
punishable with imprisonment upto 3 months and with fine upto 500 rupees

17. New regulatory guidelines by Dept. of AYUSH
• Also known as Good Agriculture Practice.
• To promote the agriculture practice of herbal drugs.
GAPs
• Also known as Good Agriculture collection practice.
• For cultivation and collection of herbal drugs.
GACPs
• Also known as Good Agriculture and field collection
practice.
• For better field selection and harvesting.
GAFCPs

18. Challenging aspects of herbal medicines:-
➢Maintenance of DNA fingerprinting
➢Phytochemical and therapeutic uniformity
➢Lack of good clinical practices, standard operating protocols
➢No proper protocols or guidelines on pk/pd issues
➢No control on residual limits
In order to meet these challenges the regulatory agencies EMEA, ICH,
AYUSH, WHO, USFDA trying to bring these herbal therapies/drugs under
regulatory pipeline under NDA approval process.
In order to meet these current challenges, the Indian herbal pharmacopoeia has
published 40 monographs monitored by Indian drugs manufacturers association
(IDMA).

19. Nature always has a solution,
but we have to dig deeper.

20. Thank You