Herbal drugs are regulated under the Drug and Cosmetic Act (D&C) 1940 and Rules 1945 in India, where regulatory provisions for Ayurveda, Unani, Siddha medicine are clearly laid down. Department of AYUSH is the regulatory authority and mandate that any manufacture or marketing of herbal drugs have to be done after obtaining manufacturing license, as applicable.

1. Quality Control & Standardization Of Herbals
Regulatory Requirements For Herbal Medicines
By
Kaushal Kumar

2. TABLE OF CONTENTS
01 02 03 04
Introduction Regulation Schedule T AYUSH

3. Introduction
Herbal drugs are regulated under the Drug and Cosmetic Act (D&C)
1940 and Rules 1945 in India, where regulatory provisions for
Ayurveda, Unani, Siddha medicine are clearly laid down.
The D&C Act extends the control over licensing, formulation
composition, manufacture, labeling, packing, quality, and export.
Schedule “T” of the act lays down the good manufacturing practice
(GMP) requirements to be followed for the manufacture of herbal
medicines.
Department of AYUSH is the regulatory authority and mandate
that any manufacture or marketing of herbal drugs have to be
done after obtaining manufacturing license, as applicable.

4. → Good Agriculture & Collection Practice
(GACP)
→ Good Manufacturing Practice (GMP)
Schedule T
→ Good Laboratory Practice (GLP)
→ Good Clinical Practice (GCP)
Regulation Of Herbal Medicines

5. Good Agriculture & Collection Practice (GACP)
GACP applies the guidance to the cultivation and collection procedures, right from selection
of herbs, botanical identity, soil, seed, cultivation techniques, environment & surroundings,
climate, irrigation, maintenance, harvesting and drying.
The collection procedures should be carried out by trained personnel with adequate
knowledge about cultivation techniques including the use of pesticides, etc.
Documentation of process and procedures, fumigants, labeling, agreements, audit results
should be maintained.
Testing details, solvents used purification stages, standardizations, etc. details of impurities
like - pesticides, fumigants, microbial contamination and its control should be documented.
Regulation Of Herbal Medicines

6. Good Manufacturing Practice (GMP)
GMP ensures product uniformity batch to batch and assists to comply with the quality
standards to meet the requirements. The quality assurance system and documentation are
crucial for GMP. Manufacturing flow chart with process control specification and standard
testing procedures are must for processing of herb, herbal preparation and herbal
medicines. The active herb specification should include, physical and chemical parameters,
impurities, microbial contaminants and adulteration.
Good Laboratory Practice (GLP)
Well planned analytical method development and analytical method validation in approved
laboratories as per GLP, will help in setting up of a quality management system to ensure
uniformity, consistency, reliability, reproducibility of the testing parameters.
It ensures reliable and quality-oriented data and contributes towards a quality product.
Stability studies of herbal substances.
Regulation Of Herbal Medicines

7. Good Clinical Practice (GCP)
Herbal medicines under the Herbal Anatomical Therapeutic Chemical (HATC) are classified
based on nomenclature and therapeutic activity to aid the study of safety and clinical data.
Department of AYUSH implemented pharmacovigilance program keeping in mind the
growing demand of acceptance of Ayurveda and thus, to ensure its safety and efficacy and
reporting of adverse reactions and to investigate the same.
A clinical trial is to be carried out. The trial when conducted requires a detailed protocol, a
principle investigator and evidence of safety and efficacy of the herbal medicine.
Regulation Of Herbal Medicines

8. To manufacture good quality Ayurvedic, Siddha and Unani medicines GMP
have been made mandatory by incorporation of revised Schedule T in the
year of 2003.
Features of schedule T
 Manufacturing process is as prescribed to maintain the standard.
 Adequate quality control measures to be adopted.
 Drugs released for sale shall be of acceptable quality.
 Raw materials to be used in manufacture of medicines must be authentic ,
prescribed quality and free from contamination.
Schedule T

9. Control on Quality of Raw Material
Quality of medicines of herbal origin mainly depends on quality of raw materials.
Presently, a major part of the raw materials are procured from wild origin, which have
almost no control on parameters of cultivation or collection etc.
Controlled cultivation could be a parameter of the quality control. If Good Cultivation
Practice and Good Harvesting Practices are developed and implemented raw materials of
good quality can be ensured.
Research for Developing Quality Control Methods
It is a fact that quality control of herbal drugs is not developing sufficiently, especially for
combination products. Research on developing standardization methods involving modern
instrumentation is urgently required. Monographs of more plants require to be
incorporated in the existing Ayurvedic Pharmacopoeia.
Effort Of Standardization

10. Clinical Trail
In third-world countries such as India, there is always a lack of interest for
conducting clinical trials, as well as a lack of coordination and effort to translate
and utilize clinical trial results within various working groups and professionals.
While most modern clinicians and researchers believe in rigorous screening and
clinical trials, most traditional medicine specialists are convinced of their drugs'
100% efficacy and regard clinical trials as unnecessary.
Effort Of Standardization

11. The Ministry of AYUSH was formed on 9th November 2014 to ensure the optimal
development & propagation of AYUSH systems of healthcare.
Earlier it was known as the Department of Indian System of Medicine & Homeopathy
(ISM&H) which was created in March 1995 & renamed as Department of (AYUSH) in
November 2003, with focused attention for development of education & research in (AYUSH).
In India, manufacturing , marketing, promotion of ASU drugs is controlled by AYUSH.
These guideline are formulated based on CDSCO document on GCP guidelines 2001 for
clinical trails on pharmaceutical products.
All ASU medicine research in India at all stages of drug development, whether prior
subsequent to product registration in India.
From 2017 onwards, its also mandatory that there must be expiry & manufacturing date present
on product label.
Ministry of AYUSH

12. THANKS!
Do you have any questions?
easyconceptkaushal@gmail.com
+91 9546688666