Manuscript Number : IJSRSET23103212

Regulatory Aspects of Herbal Formulations in India

Authors(5) :-Dr. Preeti Kulkarni, Yogesh Hadal, Shivam Amare, Bhakti Patil, Bhaskar Vaidhun

Herbal medications got from restorative plants are utilized by a larger part of individuals as a result of their security and less aftereffects, yet it isn’t totally a fact that natural items make no side impacts or poisonous impacts, they truly do convey gambles. Administrative specialists of various nations manage the quality and standard of home-grown drugs based on issues related with them, for example, spice drug collaboration, aftereffects, harmfulness and unfriendly impacts. The International Drug Monitoring Program of World Health Organization has made specific rules for home grown drugs assessment and quality check. The WHO has gone through different endeavors to improve natural medications with regards to their wellbeing and viability. The natural medication poisonousness emerges when the medication is utilized without legitimate signs, in enormous dosages, or with different medications, for longer span without discussion of a doctor, and made suitable.

Authors and Affiliations

Dr. Preeti Kulkarni
Department of Quality Assurance, Gahlot Institute of Pharmacy, Koparkhairane, Navi Mumbai, Maharashtra, India
Yogesh Hadal
Department of Quality Assurance, Gahlot Institute of Pharmacy, Koparkhairane, Navi Mumbai, Maharashtra, India
Shivam Amare
Department of Quality Assurance, Gahlot Institute of Pharmacy, Koparkhairane, Navi Mumbai, Maharashtra, India
Bhakti Patil
Department of Quality Assurance, Gahlot Institute of Pharmacy, Koparkhairane, Navi Mumbai, Maharashtra, India
Bhaskar Vaidhun
Department of Quality Assurance, Gahlot Institute of Pharmacy, Koparkhairane, Navi Mumbai, Maharashtra, India

WHO, Ayush, Herbal medicine, Regulatory aspects

  1. Regulatory aspects. Safety Concerns for Herbal Drugs. 2015;132–63. Doi:10.1201/b19064-11
  2. Kumar S, Walia R, Saxena S, Dey P, Madaan R. Regulatory considerations of herbal bioactive–based formulations. Herbal Bioactive-Based Drug Delivery Systems. 2022;419–36. Doi:10.1016/b978-0-12-824385-5.00009-1
  3. Dhawan S, Hooda P, Nanda S. Herbal nano formulations: Patent and regulatory overview. Applied Clinical Research, Clinical Trials and Regulatory Affairs. 2018;5(3):159–80. Doi:10.2174/2213476x0501180528085407
  4. Rosholt AP. Cosmetic anti-aging formulations—international regulatory aspects. Skin Aging Handbook. 2009;393–408. Doi:10.1016/b978-0-8155-1584-5.50019-3
  5. Pandey RK, Shukla SS, Vyas A, Jain V, Jain P, Saraf S. Regulatory aspects for Herbal Drugs. Fingerprinting Analysis and Quality Control Methods of Herbal Medicines. 2018;45–54. Doi:10.1201/b22160-5
  6. Hooda R, Pandita D, Kumari P, Lather V. Regulatory and quality aspects of herbal drugs. Applied Clinical Research, Clinical Trials and Regulatory Affairs. 2017;4(2). Doi:10.2174/2213476x04666170619092022
  7. Lalhriatpuii T. HPTLC fingerprint in herbal drug formulations. Herbal Medicine in India. 2019;337–62. Doi:10.1007/978-981-13-7248-3_22
  8. Singh G, Kaur P, Singh G. Antipsychotic Indian herbal formulations: An overview. Indian Research Journal of Pharmacy and Science. 2017;04(01):915–24. Doi:10.21276/irjps.2017.4.1.6
  9. Shukla SS, Pandey RK, Gidwani B, Kalyani G. Regulatory requirements for herbal medicines in India [Internet]. Springer Nature Singapore; 1970 [cited 2023 Jun 19]. Available from: https://link.springer.com/chapter/10.1007/978-981-19-9002-1_15
  10. Sahoo N, Manchikanti P. Herbal drug regulation and commercialization: An Indian Industry Perspective [Internet]. U.S. National Library of Medicine; 2013 [cited 2023 Jun 19]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3868382/
  11. Sharma S. Current status of Herbal Product: Regulatory Overview [Internet]. U.S. National Library of Medicine; 2015 [cited 2023 Jun 19]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4678984/
  12. Paliwal R, Paliwal SR. Quality control, scale-up, and regulatory aspects of herbal nanomedicine [Internet]. Springer Singapore; 1970 [cited 2023 Jun 19]. Available from: https://link.springer.com/chapter/10.1007/978-981-15-9692-6_7
  13. Regulatory requirements for Herbal Medicines [Internet]. [cited 2023 Jun 19]. Available from: https://www.slideshare.net/DrJITENDRAPATEL1/regulatory-requirements-for-herbal-medicines
  14. [Internet]. [cited 2023 Jun 19]. Available from: https://www.researchgate.net/publication/352665627_Current_regulations_for_Herbal_Medicines_in_India
  15. Cupp MJ. Legal/regulatory aspects of herbal products. Toxicology and Clinical Pharmacology of Herbal Products. :3–8. Doi:10.1385/1-59259-020-9:3

Publication Details

Published in : Volume 10 | Issue 4 | July-August 2023
Date of Publication : 2023-08-30
License:  This work is licensed under a Creative Commons Attribution 4.0 International License.
Page(s) : 280-285
Manuscript Number : IJSRSET23103212
Publisher : Technoscience Academy

Print ISSN : 2395-1990, Online ISSN : 2394-4099

Cite This Article :

Dr. Preeti Kulkarni, Yogesh Hadal, Shivam Amare, Bhakti Patil, Bhaskar Vaidhun, " Regulatory Aspects of Herbal Formulations in India, International Journal of Scientific Research in Science, Engineering and Technology(IJSRSET), Print ISSN : 2395-1990, Online ISSN : 2394-4099, Volume 10, Issue 4, pp.280-285, July-August-2023. Available at doi : https://doi.org/10.32628/IJSRSET23103212      Journal URL : https://res.ijsrset.com/IJSRSET23103212

Article Preview