This chapter, besides sharing the story behind the formulation and
development of Ayurvedic medications acceptable in modern medicine, provides a
detailed standard operating procedure for developing Ayurvedic drugs. To fight the
COVID-19 infection, caused by the SARS-CoV-2 coronavirus, Patanjali Research
Institute (PRI), Haridwar, developed the Divya Swasari Coronil kit. It contains Coronil
Tablet, Divya Swasari Vati, and Divya Anu Taila. Divya Pharmacy, Haridwar, India,
has obtained a manufacturing license from the Ayurvedic & Unani Department of
Uttarakhand, Dehradun (License No.: 13-71-72/D-431/2020-2021) for Coronil and
Swasari Vati tablets. Divya Coronil tablet has been formulated from a blend of Giloy,
Ashwagandha, and Tulsi, whereas Divya Swasari Vati and Divya Anu Taila were
prepared according to the classical recipe mentioned in traditional Ayurvedic texts.
Analytical methods have been developed to identify and quantify the active
phytoconstituents present in these blends and tablets. Sophisticated techniques are used
in the manufacturing of these tablets, like liquid chromatography, equipped with single
quadrupole, colloisan cell and time of light (UPLC/QToF MS), high-performance
liquid chromatography (HPLC) equipped with PDA detector and high-performance
thin layer chromatography (HPTLC) with automatic spotting, in which developing and
scanning chambers are used for the identification and quantification of herbs. The
methods have been validated in-house using ICH-Q2 (R1) and pharmacopoeia
guidelines to demonstrate the repeatability, reproducibility, and reliability of the data
generated. There are stringent quality checks for the authentication of raw material
used in the manufacturing of the tablet, along with in-process checks and the final
release of the batch. The herbs used during the manufacturing of these products have
been authenticated, and voucher specimens have been stored in a government-approved
depositary. The synergistic effect of these tablets has been studied by Patanjali
Research Institute (PRI) for their immunity-boosting properties and the restoration of
health of SARS-CoV-2 infected patients.
Keywords: CoP, HPTLC, Manufacturing license, Pharmacopoeia guidelines, Raw material selection and sampling, UPLC/QToF MS.
