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Herbal Drug Regulatory Affairs

Updated: Dec 19, 2022

Herbal medicines, known as phytomedicines or botanical medicines (Phyto- Plant) contains plant parts like, leaves, roots, stem, flowers, and seeds for therapeutic purpose.

It is the oldest and still most generally used system of medicine in the world at present. 80% of the world population relies on herbal medicines as their primary healthcare system.

As per WHO Herbal medicines are of three types:

1. Raw plant materials.

2. Processed plant materials.

3. Medicinal herbal products.

Since 80% of world population relies on Herbal medicines, the question of regulating of such medicines popped up. In India regulation of Herbal Medicines is carried out by The Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy (AYUSH)

Birth of Ministry of AYUSH

Department of Indian System of Medicine and Homeopathy (ISM&H) was created in March 1995 and was later renamed in 2003 as Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy (AYUSH). This department focused on Education and Research in of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy.

Ministry of AYUSH was formed in 2014 to ensure the optimal development and propagation of AYUSH systems of Healthcare. In India, manufacturing, marketing, promotion of AYUSH medicines is controlled by Ministry of AYUSH.

Research and Development in AYUSH

Research & Development in the field of AYUSH system in different areas such as drug development including quality assurance, pre-clinical safety evaluation and clinical research are being conducted at different levels such as Research Council under AYUSH, Academic institutions (both AYUSH and non AYUSH institutes such as Medical Colleges, Universities etc.), other Research organization such as ICMR, CSIR etc. Further, research support is also being extended through grant under EMR vide Ministry of AYUSH, DST, DBT, ICMR etc. in the area of traditional medicine. Lot of research is being conducted at different levels as above in the field of AYUSH adopting different guidelines, methods and protocols and ending up research outcomes with low or poor translational value. Only few of them have led to clinical trial and marketing level. This may be attributed to lack of awareness regarding AYUSH strategies for R&D and provisions of Drug & Cosmetic Act related to AYUSH. In spite of availability of several guidelines such as GCP guidelines for ASU drugs, ICMR guidelines for biomedical research for human participants, GCP guidelines published by CDSCO Ministry of Health and Family Welfare, WHO guidelines for traditional medical research etc., there is no single comprehensive directive to conduct research in AYUSH sector is available. This might be one among the major reasons that has led to R&D in AYUSH sector with diverse approaches with low translational value.

Guidelines for Herbal Medicines

Ministry of AYUSH release guidelines from time to time to regulate the AYUSH Drugs. In March 2013 Ministry of AYUSH published new GCP (Good Clinical Practices) guidelines for Clinical trials on AYUSH Drugs.

These guidelines are formulated based on CDSCO (Central Drugs Standard Control Organisation) document on GCP guidelines (2001) for clinical trials on Pharmaceutical products. These should be followed for carrying out all the AYUSH medicine research in India at all stages of drug development, whether prior or subsequent to product registration in India.

These GCP guidelines have to be followed during a clinical trial; if these guidelines are not followed then the Clinical trial will be suspended by Regulatory authorities. These guidelines also provide the compensation related guidelines for participants if any unwanted result or death of participants occurs during clinical trial. From 2017 onwards, it’s also mandatory that there must be expiry and manufacturing date present on product label.

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