INTRODUCTION TO DISSERTATION

COMPARATIVE STUDY OF CURRENT REGISTRATION

REQUIREMENTS OF CORONIL TABLETS FOR TARGETED
COUNTRIES : MALAYSIA, PHILIPPINES, THAILAND

PRESENTED BY: PROJECT SUPERVISOR:

Sumera Shailesh Dr. Jagruti Desai
22MPHRGA009 Assistant professor
M.PHARM (REGULATORY Department of pharmaceutics &
AFFAIRS) Pharmaceutical technology
RPCP
 Table of contents

01. Introduction 04. Rationale

02. Literature review 05. Plan of work

03. Aim & objectives 06. References

 Introduction
CORONIL Tablet is an Ayurvedic medicine developed by Patanjali
Ayurveda, a well-known consumer goods company in India.

Initially, it was advertised as a cure for COVID-19, but later it was licensed
as an "immunity booster" after controversy about its trial and efficacy in
India.

The tablet is designed to boost immunity and help in the management of

COVID-19 as a supporting measure.

It contains a herbal formulation with extracts from Giloy (Tinospora

cordifolia),Ashwgandha (Withania Somnifera) and Tulsi (Ocimum
Sanctum).

The tablet is used to control cough, wheezing, and breathing difficulty

 1. CORONIL tablet may be marketed as Finished herbal product In Malaysia
As per Drug Registration Guidance Document
 Finished herbal products consist of herbal preparations made from one or more herbs. If more than one herb
is used, the term “mixture herbal product” can also be used. Finished herbal products and mixture herbal
products may contain excipients in addition to the active ingredients.

2. CORONIL tablet may be marketed as herbal medicines In Philippines

As per Department of Health Administrative Order No. 172 s. 2004
 Herbal medicines are finished, labelled medicinal products that contain as active ingredient(s) aerial or
underground parts of plants or any other plant material, or combination thereof, whether in the crude state or
as plant preparation. herbal medicines may contain excipients in addition to the active ingredients.

3. CORONIL tablet may be marketed as herbal drug In Thailand

As per Herbal product Act B.E 2562(2019)
 herbal drugs, which shall include Thai traditional drugs, developed herbal drugs, traditional drugs for use in
human beings under the law on drugs or drugs derived from the knowledge of alternative medicine as
prescribed in a Notification by the Minister upon the recommendation of the Committee, for the therapy,
treatment and alleviation of human illnesses or the prevention of diseases
 Literature review
Sr. No. Article Title Author
1 Overview on development of ASEAN traditional and Chang-xiao Liu
herbal medicines
2 Regulatory Requirement Sufficiency for Registration of Malathi seshasayee konda ramadoss and k.
Traditional Herbal Medicine Based Products in Koumaravelou
Association of Southeast Asian Nations Regions: A
Model Study with Ashwagandha Tablets

3 A Review of Herbal Regulations in India and Swathi. J, D. Nagasamy Venkates

Worldwide
4 Coronil, a Tri-Herbal Formulation, Attenuates Spike- Acharya Balkrishna, Swati Haldar ,Hoshiyar
Protein-Mediated SARS-CoV-2 Viral Entry into Human Singh, Partha Roy, Anurag Varshney
Alveolar Epithelial Cells and ProInflammatory
Cytokines Production by Inhibiting Spike Protein-
ACE-2 Interaction
 Aim & objectives
Aim
 Comparision of Registration requirements of CORONIL tablet in Malaysia, Philippines
and Thailand.
Objectives
To study & compare the registration process of CORONIL tablet
To understand the documentation requirements
To Identify the challenges and opportunities for registration
To prepare a dossier of CORONIL tablet for Malaysia
 Rationale
 CORONIL, a tri-herbal formulation developed by Patanjali Ayurveda Limited, gained significant attention
during the COVID-19 pandemic as a potential treatment for the virus.
 Malaysia, Philippines and Thailand are widely dependent on the Chinese tradition medicines, by
understanding the registration requirements of herbal medicines in this countries we can expand
herbal/traditional medicines business.
 According to department of statistics ,Malaysia imported
2019 2021 CAGR
197.9 M USD 227.9 M USD 15%
 According to the Philippine Statistics Authority imported
2021 2022 CAGR
10.7 M USD 11.8 M USD 10%
 According to the International Trade Centre (ITC), Thailand imported
2020 2021 CAGR
2.07 B USD 2.3 B USD 10%
 Plan of work
Objectives Months

AUG SEP OCT NOV DEC JAN

Literature review

To study the regulation of Coronil

tablet in Malaysia, Philippines, &
Thailand

To Compare the regulations

Dossier preparation

Thesis writing

Completed work Remaining work

 References
1. Liu CX. Overview on development of ASEAN traditional and herbal medicines. Chinese Herbal
Medicines. 2021 Oct 1;13(4):441-50.
2. Ramadoss MS, Koumaravelou K. Regulatory Requirement Sufficiency for Registration of
Traditional Herbal Medicine Based Products in Association of Southeast Asian Nations Regions: A
Model Study with Ashwagandha Tablets. Indian Journal of Pharmaceutical Sciences. 2022 Mar
1;84(2).
3. Swathi J, Venkatesh DN. A review of herbal regulations in India and Worldwide. Research Journal
of Pharmacy and Technology. 2022;15(3):1348-52.
4. Ismail SF, Abd Ghani Azmi IM, Daud M, Abd Jalil J, Safuan S. REGULATORY CONTROL OF
HERBAL AND TRADITIONAL MEDICINES IN MALAYSIA: ISSUES AND CONCERNS.
International Journal of Business & Society. 2020 Jan 2;21.
5. Moph.go.th. 2019 [cited 2023 Sep 21]. Available from:
https://en.fda.moph.go.th/media.php?id=516853653160730624&name=Herbal%20Product%20Act,
%20B.E.2562(2019).pdf
6. Gov.ph. [cited 2023 Sep 21]. Available from:
https://www.fda.gov.ph/wp-content/uploads/2021/04/Administrative-Order-No.-172-s.-2004.
 References
7. Gov.my. 2023 [cited 2023 Sep 21]. Available from:
https://npra.gov.my/easyarticles/images/users/1153/DRGD%20July%202023/Complete-Drug-Regis
tration-Guidance-Document-DRGD-3rd-Edition-5th-Revision-July-2023.pdf
8. Herbal Medicinal Products Market market size, share, growth analysis - industry forecast 2022-
2028 [Internet]. Skyquestt.com. [cited 2023 Sep 21]. Available from:
https://www.skyquestt.com/report/herbal-medicinal-products-market
9. Balkrishna A, Haldar S, Singh H, Roy P, Varshney A. Coronil, a Tri-herbal formulation, attenuates
spike-protein-mediated SARS-CoV-2 viral entry into human alveolar epithelial cells and pro-
inflammatory cytokines production by inhibiting spike protein-ACE-2 interaction. J Inflamm Res
[Internet]. 2021 [cited 2023 Sep 26];14:869–84. Available from:
http://dx.doi.org/10.2147/jir.s298242