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Regulatory Aspects and Challenges in Herbal Formulations

11th & 12th January 2019

Objectives of the workshop

Herbal products have become an important and indispensable part of public healthcare around the world. Various surveys on traditional and alternative medicine have highlighted their widespread use.

India has been a historical custodian of such traditional knowledge for centuries. Therefore, today, India is one of the rich sources of herbal medicines and has potential to meet the global demand. The herbal drug market has been rapidly growing due to increasing global interest. However, to utilize this opportunity, there is urgent need for research based scientific development and standards based quality control of herbal dugs, as well as relevant regulatory enforcement.

However, in order to further widen their forum of acceptance, clinical trials of these herbal products should be encouraged. To prove the efficacy of in clinical trials, it is advised to use single and consistent batches of formulations. Although herbal practitioners and believers do not require clinical trials, for its large scale endorsement and survival at the international market alongside modern medicines, it has become need of the hour.

The present review thus focuses on the challenges of the clinical research of herbal medicines as well as the regulatory issues concerning herbal medicines with following objectives:

  1. To explore, the current regulatory aspects in the field of Pharmacognosy and Phytochemistry including botanicals, herbal products, traditional formulations, and other bioactive natural products.
  2. To address the challenges related to the financial, ethical, product standardization (quality control), the design of the study and the regulatory requirements for conducting clinical research.
  3. To minimize the gap in meeting legislative requirements for research on herbal drugs.



SNJBs Shriman Sureshdada Jain College of Pharmacy run by charitable trust SNJB (Jain Gurukul) in Chandwad Dist. Nashik. Trust is providing education for all since 1928. The trust is functioning under the excellent and dynamic team of Trustees and Directors headed by Chairman Shri. Santokchandji Surana The pharmacy college established in year 1999 and is approved by AICTE, PCI, Govt. of Maharashtra and permanently affiliated to S.P.Pune University, Pune. The college offers Diploma, Undergraduate, Postgraduate and Ph.D. Course in Pharmacy. Our college started Master in Pharmaceutics in year 2008 and subsequently added Master in Pharmacology in year 2011 and our Ph.D. Research Centre is approved by SPPU in 2011. The college is enriched with a team of experienced and dedicated faculties providing basic and applied pharmacy education to the students. 171 students passed out there masters and 02 students have been awarded PhD from our centre. The experienced and committed faculty members have fetched the research grants from various funding agencies like AICTE, DST, SPPU of worth Rs.75 lac which has contributed immensely in the development of all departments with advanced and sophisticated instruments.

Regulatory Aspects and Challenges in Herbal Formulations

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