Torrent Pharma Gets CDSCO Nod for Prucalopride Oral Solution

Torrent Pharmaceuticals got the green light from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to produce and sell Prucalopride Oral Solution (0.2 mg/mL).

The go-ahead is in line with a decision by the SEC dated July 29, 2025, when the company provided a full safety dossier illustrating the synergistic effect of the excipients - propylene glycol, glycerol, and sorbitol - used in the tested formulation.

After going through the material, the Gastroenterology and Hepatology panel of experts, to whom the questions were referred, had a detailed discussion and unanimously agreed to grant permission for the manufacture and marketing.

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Prucalopride is a serotonin 5-HT4 receptor agonist which is used in the treatment of chronic idiopathic constipation in adult patients. It is a selective stimulator of 5-HT4 receptors and does not affect the hERG channel or 5-HT1 receptors, thereby, greatly reducing the cardiovascular risks, which were the cause of earlier drugs of the same class.

One of the main excitatory neurotransmitters, acetylcholine, is released as Prucalopride, through its 5-HT4 receptors located all over the gastrointestinal tract - mainly in smooth muscle cells and the myenteric plexus - stimulates muscle contraction. This leads to the muscle contractions working together to achieve bowel movement.

The SEC’s approval is a significant milestone for Torrent Pharma as it strives to broaden its gastroenterology portfolio and thus, extend its commitment to the Indian pharmaceutical sector by introducing novel therapies.