Published January 1, 2025
| Version v1
Journal article
Open
Regulatory Landscape For Phytopharmaceuticals In India
- 1. 1*Department of Pharmacology, Hygia College of Pharmacy, Lucknow 2Associate Professor, Sri Venkateshwara College of Pharmacy, Madhapur, Hyderabad
Description
Abstract
India is establishing itself as a significant contender in the global phytopharmaceutical market with the increasing need for plant-based medicines. To properly capitalize on this opportunity, a definitive and supporting regulatory framework is necessary. The regulatory framework for phytopharmaceuticals in India has seen substantial evolution, with the government and the Ministry of AYUSH implementing systematic procedures to guarantee quality, efficacy, and safety. This newsletter examines India's regulatory framework, significant milestones, and prospective developments in the phytopharmaceutical business.
Keywords
Phytopharmaceuticals, Regulatory framework, AYUSH.
Files
27-29-Neeraj Verma-2152961553.pdf
Files
(343.7 kB)
| Name | Size | Download all |
|---|---|---|
|
md5:ba0f5b3605610e2e64dcb252155bba5f
|
343.7 kB | Preview Download |
Additional details
Dates
- Available
-
2025-01-01Volume 15 issue 1 2025
References
- 1. Chaudhary A, Singh N, Nagpal N, Arora P, Dhingra GA. Phytopharmaceuticals: A new class of drugs in India. Indian J Pharmacol, 48(5):469-470, 2016. doi:10.4103/0253-7613.190733 2. Kumar A, Shukla R, Singh P. Regulatory framework of herbal products in India. Pharmacogn Rev, 13(26):52-60, 2019. doi:10.4103/phrev.phrev_13_19 3. Gupta V, Sharma VK, Chatterjee M. Phytopharmaceuticals: Standards and regulatory requirements for new drug development. Int J Drug Res Tech, 10(2):85-93, 2020. 4. Ministry of AYUSH, Government of India. Guidelines for Phytopharmaceutical Drug Development in India. Ministry of AYUSH, India, 2016. Available from: 5. https://pharmaceuticals.gov.in/sites/default/files/phytopharmaceutical_guidelines.pdf 6. Tiwari M, Kadu S, Bansal AK, Singh A, Mishra A. Phytopharmaceuticals: Regulatory framework and its challenges. J Appl Pharm Sci, 10(7):122-128, 2020. 7. Ravi G, Deepa K, Ezhilarasi V. Quality Control and Standardization of Herbal Drugs and Phytopharmaceuticals. J Res Pharm Sci, 12(5):281-287, 2021. 8. Saini P, Sharma D, Sharma S. Regulatory challenges in development of herbal drugs in India: An overview. Asian J Pharm Clin Res, 11(5):12-16, 2018. 9. Bhalerao S, Verma S, Sohani M, Gauri S. Phytopharmaceuticals in India: Growth, opportunities, and regulatory challenges. J Herb Med, 28:100457, 2022. doi:10.1016/j.hermed.2021.100457 10. Rathi AK, Tripathi A. Phytopharmaceuticals - regulatory scenario in India. World J Pharm Pharm Sci, 6(3):1621-1628, 2017. 11. World Health Organization (WHO). Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. Geneva: World Health Organization, 2003. Available from: https://apps.who.int/iris/handle/10665/42783 12. Chakraborty S, Naskar R, Mukherjee S. Phytopharmaceutical drug development: Indian regulations and international perspectives. Pharmacogn J, 13(2):354-361, 2021. 13. Saxena R, Jaiswal P, Rajput J. Quality assurance of herbal and phytopharmaceutical products in India: An overview. J Glob Trends Pharm Sci, 11(2):1234-1240, 2020. 14. Singh T, Biswas A. Future scope of phytopharmaceuticals and nutraceuticals in India. J Adv Pharm Technol Res, 12(3):89-97, 2021. 15. Verma R, Das G, Singh S. Regulatory aspects of phytopharmaceuticals: A global perspective. J Ethnopharmacol, 264:113185, 2021. doi:10.1016/j.jep.2020.113185 16. Yadav SK, Mehta A, Rajpoot A. Market analysis and regulatory framework for phytopharmaceuticals in India. Asian J Res Chem, 14(1):47-53, 2021. 17. Bhatia A, Prasad R. Phytopharmaceutical drugs: Development, regulation, and prospects in India. Asian J Pharm Clin Res, 13(10):45-50, 2020. 18. Kumar S, Pandey A. Indian guidelines for clinical trials of phytopharmaceuticals. J Pharm Bioallied Sci, 13(5):1-5, 2021. doi:10.4103/JPBS.JPBS_48_20 19. Mishra P, Singh M, Rana M. Challenges in the regulation and standardization of phytopharmaceuticals in India. Int J Herb Med, 8(4):24-30, 2020. 20. Patil S, Gopalakrishnan M, Chaudhari S. Regulatory framework of phytopharmaceuticals: Opportunities and challenges. Curr Trends Pharm Res, 8(1):100-110, 2022. 21. Sharma N, Tripathi MK. Quality control and standardization of herbal medicines in India. J Herb Med, 11(2):98-105, 2021.