Torrent Pharma Gets CDSCO Panel Nod to Manufacture, Market Prucalopride Oral Solution
New Delhi: In a significant regulatory development, Torrent Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market Prucalopride Oral Solution 0.2 mg/mL.
The approval comes in light of the earlier SEC recommendation dated July 29, 2025, after the firm presented safety data on the synergistic effect of added excipients (Propylene glycol, Glycerol and Sorbitol) with Prucalopride in the applied Formulation before the committee.
Prucalopride is a 5-HT4 receptor agonist indicated to treat adults with chronic idiopathic constipation.
Prucalopride acts as a selective stimulator of the 5-HT4 receptors while having no interaction with the hERG channel or 5-HT1 receptors, which significantly reduces the cardiovascular risk found in other similar drugs.
5-HT4 receptors can be found throughout the gastrointestinal tract, primarily in smooth muscle cells, enterochromaffin cells, and the myenteric plexus. Its activation produces the release of acetylcholine, which is the major excitatory neurotransmitter in the GI tract.
Hence, prucalopride stimulates motility by interacting specifically with 5-HT4 receptors in the GI tract, which causes a release of acetylcholine and further contraction of the muscle layer of the colon and relaxation of the circular muscle layer, leading to the propulsion of luminal content.
At the recent SEC meeting for gastroenterology and hepatology, the expert panel reviewed the safety data on the synergistic effect of added excipients (Propylene glycol, Glycerol and Sorbitol) with Prucalopride in the applied Formulation.
After detailed deliberation, the committee recommended for the grant of permission for the manufacture and marketing of Prucalopride Oral Solution 0.2 mg/mL.
