¹M.Pharm, Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS University, Mysuru- 570015

²Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Mysuru- 570015

This email address is being protected from spambots. You need JavaScript enabled to view it.

Abstract

Herbal medicine has been practiced for centuries in many countries butthe legalityof herbal medicines varies from country to country. In certain countries herbal medicines are well-established, but they are not used under legal claim instead they are regarded under food and therapeutic claim. Developing countries, however, often have a great number of traditionally used herbal medicines and much folk-knowledge about them, but have hardly any legislative criteria to establish these traditionally used herbal medicines as part of the drug legislation. The herbal medicine sector is in a dilemma. Some practitioners would like to continue to practice as they do now, with no further regulation, and accept that their practice is based on tradition and personal experience rather than empirical science. The logical consequence of adopting this form of practice is that we should take a precautionary approach in order to ensure public safety. This article presentsoverview of regulatory challenges of herbal medicine in world and regulation, types of documents for herbal medicine in Russia.This work clearly gives the overview of the herbal drug registration requirements in Russia and also about the marketing authorization procedure and timelines involve.

 REFERANCES 

 1.      Standardization of herbal medicines. Available at

http://www.academicjournals.org/article/article1380017716_Kunle%20et%20al.pdf

2.      Regulatory situation of herbal medicines. Available at

http://www.dcscience.net/Report_on_Regulation_of_Herbal_Medicines_and_Practitioners.pdf

3.      Report on the regulation of herbal medicines and practitioners.

4.      The Safety of Herbal Medicine: From Prejudice to Evidence. Available at

http://www.hindawi.com/journals/ecam/2015/316706/

5.      Current Scientific Status and Regulatory Control of Herbal medicine. Available at

http://www.ijrap.net/admin/php/uploads/639_pdf.pdf

6.      Regulatory issues of herbal medicine. Available at

www.clininvent.com/.../Regulatory%20issues%20for%20tradintionl%2

7.      Regulatory situation of herbal medicine worldwide. Available at

http://apps.who.int/medicinedocs/pdf/whozip57e/whozip57e.pdf

8.      WHO guideline on safety monitoring. Available at

apps.who.int/medicinedocs/documents/s7148e/s7148e.pdf

9.      Guidelines for the Appropriate use of Herbal Medicines. Available at

apps.who.int/medicinedocs/en/d/Jh2945e/11.html

10.  Framework for overcoming barriers of complementary and alternative medicine acceptance into conventional healthcare system. Available at

http://www.academia.edu/5116752/Framework_for_overcoming_barriers_of_complementary_and_alternative_medicine_acceptance_into_conventional_healthcare_system

11.  Pharmacovigilance of Herbal Products. Available at

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3159283/

12.  Pharmacovigilance of Herbal Products in India. Available at

https://www.researchgate.net/publication/51620397_Pharmacovigilance_of_Herbal_Products_in_India

13.  Regulatory framework for federal service for surveillance in healthcare. Available at

http://www.roszdravnadzor.ru/en

14.  Russian Federation Federal Law On Circulation of Medicines 61-FZ (EN).Available at

https://www.unodc.org/res/cld/document/rus/federal-law-on-circulation-of

medicines_html/Russian_Federation_Federal_Law_On_Circulation_of_Medicines_61-FZ_EN.pdf

15.  Medicinal Plants of the Russian Pharmacopoeia; their history and applications. Available at

http://www.sciencedirect.com/science/article/pii/S0378874114002827

16.  European view on current regulatory legislation in the CIS countries. Available at

http://dgra.de/media/pdf/studium/masterthesis/master_dranov_a.pdf

17.  Regulatory framework for federal service for surveillance in healthcare. Available at

http://www.roszdravnadzor.ru/en

18.  Russia. Functions. Federal service on surveillance in healthcare and social development of Russian federation. Roszdravnadzor. Russia.  Ministry of Health; 2007. [Cited 2012 Dec 15]. Available from:

http://www.roszdravnadzor.ru/i/upload/files/1188395609.65833-4011.pdf

19.  Alyona C. Registration of Pharmaceutical products in Russia. Pharmareg. [Internet] [Cited 2015 Jan 25]. Available from:

http://pharmareg.ru/upload/ReportAChorichFrankfurt.pdf

20.  Regulation of Herbal Medicinal Products in Russia. Available at

https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0032-1307488

21.  States registration of herbal drug in Russia. Available at

http://www.msp.ua/registration-medicinal-products-russia.html

22.  Docs for registration in Russia _for medical. Available at

http://www.china-canny.com/html/fqabv.html

23.  Satyanarayan, Shanta. "Full Scale Treatment of Herbal Pharmaceutical Industry Wastewater."  [Internet] [Cited 2014 Nov 15] Available at

http://www.ijcps.org/sp1/p7.pdf

24.  National Policy on Traditional Medicine and Regulation of Herbal Medicines- Report on WWHO global survey. [Internet]. [Cited 2014 Nov 15]Available at

http://apps.who.int/medicinedocs/en/d/Js7916e/9.4.html

http://globalresearchonline.net/journalcontents/v31-1/30.pdf