ABSTRACT

Diabetes mellitus is rising globally, and post-prandial hyperglycemia is a key driver of complications. Plant-derived alpha-glucosidase inhibitors and insulin-sensitizing agents are being explored as better-tolerated options. Cassia absus has long-standing ethnomedicinal use for glycemic control. To evaluate the anti-diabetic potential of an ethanolic leaf extract of Cassia absus via (i) alpha-glucosidase inhibition and (ii) enhancement of glucose uptake in vitro, alongside phytochemical profiling and comparison with   standards. Leaves were shade-dried, powdered and ethanol-extracted. Qualitative tests and quantitative assays (HPLC and spectrophotometry) profiled gymnemic acids, flavonoids, saponins and tannins. Alpha-glucosidase inhibition was quantified using p-nitrophenyl-?-D-glucopyranoside across 100–1000 µg/mL; acarbose served as positive control and IC?? was determined. A non-cellular 2-NBDG assay assessed glucose uptake across the same concentrations with insulin as comparator. Experiments were run in triplicate and analyzed by one-way ANOVA. The extract contained abundant gymnemic acids (I–IV) with notable levels of flavonoids, saponins and tannins. Alpha-glucosidase activity was inhibited in a dose-dependent manner, reaching 98.5% at 1000 µg/mL (IC?? ? 350 µg/mL), exceeding acarbose inhibition at the same concentration (89.3%). The extract also increased glucose uptake up to 96.2% at 1000 µg/mL, outperforming insulin (80.2%) under assay conditions. Statistical analyses indicated significant effects for both endpoints (p < 0.05). Cassia absus exhibits dual anti-diabetic actions potent alpha- glucosidase inhibition and marked enhancement of glucose uptake supporting its promise as a natural adjunct for managing post-prandial glycaemia and improving peripheral glucose handling.

Keywords: Cassia absus; alpha-glucosidase inhibition; glucose uptake; gymnemic acids; antidiabetic; in vitro study

ABSTRACT

A regulatory process of drug approval is very important in ensuring that new pharmaceutical products are safe, effective and produced without quality standards. In this review, the approval procedures in India, The US and Canada are compared. This also involves an organized evaluation that is supported by scientists. The three systems aim to safeguard the well-being of the masses by ensuring that medicines reach the patients only when they are well characterized, evidence based, and of the highest quality, irrespective of the system structure, documentation requirements, reviewing period and the regulatory authority roles. This comparative study outlines similarities and specific regulatory aspects to define Indian, U.S., and Canadian drug-approval process.

Keywords: Drug approval process, Regulatory affairs, Pharmaceutical regulations, New drug approval, CDSCO, USFDA, Health Canada, Clinical trials, Regulatory authority, Drug safety and efficacy.