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SSDI Division

DRUG

Drug Development Program

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Drug Development Program

Preamble
Majority of drugs in current practice are from synthetic origin. Even so, a large number of these synthetic molecules are based directly or indirectly on natural products or phyto-constituents.

The present medicinal system is dominated by the Allopathy or western medicine which is prominently taught and practiced in most of the countries worldwide. However, majority of people in India faithfully credit Ayurveda, one of the oldest systems of medicine originated in ancient India thousand years ago (about 4500 BC). The first choice for the drugs in the Ayurveda was the natural products such as roots, stems, barks, and fruits of plants in the vegetable kingdom, however, several therapeutic agents from the animal kingdom and the mineral kingdom were also chosen by Ayurveda scholars. Animal products like Kasturi (Musk), Amber, Pearls, Conch and duly processed Corals became equally popular therapeutic agents along with metals and metal products especially Mercury, Gold, Copper, and Sulphur etc. It resulted in the genesis of compound drugs and formulations for variety of human and animal ailments and diseases. There are many diseases which cannot be cured with allopathic drugs but Ayurveda has provided us with many hints for drug development by using herbs and minerals. In UCOST, our primary focus is to identify Ayurvedic drugs which have been developed by Ayurvedic practitioners or traditional healers in Uttarakhand and promote them to study safety, efficacy, and pharmacology using modern scientific tools and techniques.
The Ayurvedic knowledge database allows drug researchers to start from a well-tested and safe botanical material and minerals. With successful clinical practice, trained Ayurvedic practitioners and traditional healers carry out numerous innovations for treatment of various ailments and diseases of men and animals. However, they lie unnoticed and abolished with practitioner's death under contemporary situation. We are of opinion that these innovations need to be carried forward forever to their ultimate goal of applications for societal concerns. Therefore, a program to promote Drug Discovery in Ayurveda has been devised by the UCOST.
With Ayurveda, the normal drug discovery course of 'laboratories to clinics' actually becomes from 'clinics to laboratories'- a reverse pharmacology approach. In Ayurvedic medicine research, clinical experiences, observations or available data becomes a starting point, while in conventional drug research, it comes at the end. Thus, the drug discovery based on Ayurveda follows a 'reverse pharmacology' path.


Objective

UCOST has prioritized following objectives for Ayurvedic drug development program:

  1. Propagation of reverse pharmacology for proven Ayurvedic drugs developed by Ayurvedic practitioners and traditional healers in Uttarakhand.
  2. Awareness programs for traditional healers and Ayurvedic practitioners for their capacity building and to make them understand the regulatory norms and IPR issues related to drug development.
  3. Efforts to protect IPR issues and to devise an effective technology management strategy including its commercialization for the potential ayurvedic drugs.
UCOST is in process to frame a network of trained Ayurvedic practitioners and traditional healers to take part in this program. However, the guidelines for aspiring Ayurveda Practitioners for their active involvement in this program, includes:
  1. At least 10 years of robust documentation of clinical observations of patients who have been treated by their developed ayurvedic drugs.
  2. Proof of efficacy of their developed formulations, duly validated by Govt. Hospitals or by National Accreditation Board for Testing and Calibration Laboratories (NABL) approved laboratory.
  3. Published clinical data for their developed ayurvedic formulations.
  4. Meticulous documentation of process and parameters used in production of ayurvedic formulations with reproducibility of quality product.
  5. Proven impact on community health scenario.

Initiatives of UCOST under Drug Development Program

UCOST promoting Ayurvedic practitioners and traditional healers to work on drug development by giving due emphasis over assessment of chemistry, quality, and production parameters along with safety and efficacy studies of developed drug following the WHO guidelines and reverse pharmacology. In order to expend the idea in the state and to work upon various projects, UCOST has taken a lead for R&D in Ayurveda mediated drug development process. We are of opinion that successful execution of these projects will be instrumental to develop novel measures of treatment for various diseases, innovation in medicine, and global promotion of Ayurveda.
Recently, UCOST has been involved in project, "Development of Herbo-mineral formulation (HMF) for treatment of Chronic Pancreatitis (CP)", with Padmshri Vaidya Balendu Prakash, the Principal Investigator of the Project. Primary objectives of the project are study of reproducibility of HMF and scale up of production (Physico-chemical characterization of in-process material and finished product and Development of in-process quality control technique and instrumentation); Pre-clinical safety studies (toxicity) of HMF; and Controlled multi-centric clinical studies on patients of CP using HMF. The HMF for CP has succeeded to obtain provisional patent, No. 3373/DEL/2014 under title, "Cu, Hg and S based Herbo-mineral formulation (HMF) for the treatment of Chronic Pancreatitis (CP)". Vaidya Balendu has a long legacy of developing proven Ayurvedic drugs for anaemia, cancer and migraine.

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