ABOUT R&D DEPARTMENT
Since its establishment in 2002, research and development have been an integral part of our company, wherein published monographs of raw materials and finished products are adhered to comply. However, the norms of the modern pharmaceutical industry and traditional manufacturing processes used in Ayurveda need to be bridged to develop new monographs. We have been constantly upgrading since then, and started with a dedicated department in 2010 for further R&D studies. The initial focus was on the addition of more stringent parameters for identity, purity and strength of raw materials as well as finished products. We are proud that we have doubled our product range since last decade with unique Ayurvedic products for the domestic and international markets. We have collaborated with several institutes for drug development and research and are constantly adding rigorous research tools to improve our standards.
FACILITY
MANUFACTURING
Pilot-scale production of new products is based on trials and a scale-up experiment facility is available for each type of Ayurvedic product. Development of standard operating procedures, batch manufacturing records, master formula records, and stability studies is carried out meticulously following FDA regulations.
TESTING
Development of standard testing procedures, in-house standards, monographs and repositories is carried out for all categories of Ayurvedic products. Basic laboratory techniques are performed in our in-house QC lab, while advanced testing is carried out at collaborator facilities to generate data.
Team
Dr Sadanand Sardeshmukh
Chairman Director
Dr Sukumar Sardeshmukh
Managing Director
Dr Vidya Hirlekar
Advisory Director
Dr Sandeep Chavan
R&D In-charge
COLLABORATIONS
Bharatiya Sanskriti Darshan Trust, Wagholi, Pune
We have been working as a drug development and manufacturing partner with BSDT such as for cancer with Integrated Cancer Treatment and Research Centre (ICTRC), Wagholi, Pune as well as other lifestyle disorders with Ayurved Hospital Research and Development. Various projects have been completed and are ongoing to develop authentic, pure, safe and efficacious Ayurvedic medicines.
Advanced Centre for Treatment, Research and Education in Cancer, Navi Mumbai
In collaboration with BSDT, we have been working on cancer research project for acute and chronic toxicity studies of herbo-mineral metallic Ayurvedic formulations in ACTREC for safety studies.
Indian Drug Research Association and Laboratory, Pune
We have been outsourcing certain testing of Ayurvedic medicines from IDRAL for basic and advanced parameters.
CSIR-National Chemical Laboratories, Pune
We had collaborated with NCL for technical services pertaining to advanced testing for metallic and mineral raw materials and drug derived such as Bhasma, Pishti and herbo-mineral metallic formulations.
RESEARCH PROJECTS COMPLETED
RESEARCH PROJECTS ONGOING
RESEARCH OUTCOMES
Research papers are published in high-impact factor, peer-reviewed international journals, highlighting standardization, characterization, monographs, quality control and assurance, safety and pre-clinical efficacy of Ayurvedic medicines.
Clinical studies conducted by BSDT’s ICTRC has published various scientific papers in reputed journals in which the medicines used for the studies are standardized, manufactured and supplied by our company.
Several case studies published by BSDT’s ICTRC, Wagholi, Pune were given standardized medicines manufactured by our company.
GLIMPSES OF PUBLISHED MONOGRAPHS
Atharva Jatamansi Taila
(Full paper: https://doi.org/10.1016/j.jaim.2024.100900)
Basic physicochemical and safety parameters as per Ayurvedic Pharmacopoeia of India.
| Batch | JO1 | JO2 | JO3 | Mean ± SEM |
| Description | Slightly yellowish colored thick, viscous liquid | |||
| Specific gravity | 0.9186 | 0.9213 | 0.9183 | 0.9194 ± 0.001 |
| Refractive index | 1.546 | 1.5455 | 1.547 | 1.546 ± 0.0004 |
| Acid value | 2.851 | 2.996 | 2.879 | |
| Saponification value | 134.84 | 149.93 | 147.83 | 144.2 ± 4.72 |
| Ester valuea | 131.99 | 146.93 | 144.95 | 141.30 ± 4.69 |
| Iodine value | 92.07 | 74.68 | 138.72 | 101.82 ± 19.12 |
| Peroxide value | 0.57 | 1.44 | 2.03 | 1.34 ± 0.42 |
| Microbial count | NMT 105 | |||
| Fungal count | NMT 103 | |||
| Heavy metals (ppm) | Hg- Nil, Cd- Nil, As- Nil | |||
| Pb- 1.404 | Pb- 1.404 | Pb- 1.119 | 1.309 ± 0.095 | |
| Specific pathogens | Absent | Absent | Absent | |
| Aflatoxins | Absent | Absent | Absent | |
aEster value = Saponification value – Acid value; JO- Jatamansi Oil, NMT: Not More Than; Hg- Mercury, Cd- Cadmium, As- Arsenic, Pb- Lead.
Atharva Yashtimadhu Taila and Atharva Yashtimadhu Ghrut
(Full paper: https://doi.org/10.1016/j.jaim.2023.100711)
Physicochemical analysis
| Parameter | Unit | Finished products | |
| Yashtimadhu Ghrut | Yashtimadhu Taila. | ||
| Specific gravity | – | 0.91 ± 0.0005 | 0.92 ± 0.002 |
| Loss on drying at 105 °C | % | 0.32 ± 0.14 | 0.08 ± 0.001 |
| Acid value | – | 1.47 ± 0.06 | 1.63 ± 0.20 |
| Refractive Index | – | 1.54 ± 0.0002 | 1.55 ± 0.001 |
| Saponification value | – | 223.13 ± 8.1 | 210.68 ± 15.95 |
| Iodine value | – | 29.75 ± 1.94 | 72.47 ± 20.77 |
| Peroxide value | – | 1.33 ± 0.37 | 0.57 ± 0.29 |
| Unsaponifiable matter | % | 0.77 ± 0.31 | 0.75 ± 0.37 |
| Reichert Meissl value | – | 35.92 ± 2.08 | NA |
| Presence of cotton seed oil | – | NA | Absent |
| Congealing point | °C | 25.0 ± 3.0 | NA |
Data: Mean ± SEM, n = 3, NA- Not applicable
Shankha Bhasma/ Incinerated conch
(Full paper: https://doi.org/10.3390/md16110450)
Parameters and specifications
| Parameters | Specification |
| Organoleptic characters | White or greyish white colour, no smell and should not taste pungent |
| Fineness | Fine like Kohl, enters the crevices of finger tips when rubbed between them. |
| Smoke test | No smoke when burnt on open flame |
| Loss on drying | Not More Than 0.5% w/w |
| Calcium as CaCO3 (Titration) | 38–40% w/w |
| Ca on ICPOES | 39–41% w/w |
| Mg on ICPOES | 0.03–0.04% w/w |
| pH of 1% solution in Distilled Water | 9–10 |
| Bulk density | 0.7000–0.8500 g/cc |
| Tapped density | 1.100–1.500 g/cc |
| XRD analysis | 100% Calcite form |
| TGA analysis | 42–44% loss after 750 °C |
| FTIR analysis | CO32− peaks at 1410, 874, 712 cm−1 |
| SEM analysis | Polygonal particles or agglomerates |
| Particle size | Effective diameter: 400–750 nm Poly-dispersity: 0.01–0.06 10% <1200 nm (1.2 μm), 50% <2600 nm (2.6 μm), 90% <5500 nm (5.5 μm) |
| Heavy metals on ICPOES | Hg, As, Cd and Pb- Within permissible limits |
Shuddha Gairik/ purified red ochre
(Full paper: http://op.niscair.res.in/index.php/IJTK/article/view/31007)
| Analysis of 3 batches of PRO from Ayurvedic perspective | |
| Ayurvedic Parameter | Observations |
| Shabda (Sound) | No sound produced when rubbed in a mortar with pestle (Nishabda) |
| Sparsha (Touch) | Soft in touch when rubbed between fingers and free flowing (Shlakshna) |
| Rupa (Appearance) | Red color powder (Rakta varna churna) |
| Rasa (Taste) | Sweet (Madhur) and astringent (Kashaya), like clay (Mruttikavat) |
| Gandha (Odor) | Characteristic of ghee (Ghrutagandhi) |
| Physicochemical analysis of 3 batches of PRO | |||||||||
| Parameter | LOD %w/w | LOI %w/w | AIA %w/w | Density Bulk g/cc | Density Tapped g/cc | Compression ability % | Iron as Fe % w/w | Silicon as Si % w/w | Oil content % w/w |
| Batch 1 | 0.69 | 18.77 | 35.86 | 0.646 | 0.888 | 27.27 | 20.23 | 16.75 | 4.62 |
| Batch 3 | 0.37 | 16.61 | 46.67 | 0.720 | 1.001 | 28.12 | 16.35 | 21.79 | 4.72 |
| Mean | 0.47 | 17.56 | 39.67 | 0.699 | 0.992 | 29.31 | 18.92 | 18.52 | 4.55 |
| SD | 0.19 | 1.10 | 6.07 | 0.05 | 0.10 | 2.84 | 2.23 | 2.83 | 0.21 |
| SE | 0.11 | 0.64 | 3.51 | 0.03 | 0.06 | 1.64 | 1.29 | 1.64 | 0.12 |
| LOD: Loss on drying, LOI: Loss on ignition, AIA: Acid insoluble ash | |||||||||