Intas Pharma Secures CDSCO Panel Approval for Post-Marketing Study of Tacrolimus Enema
New Delhi: With the recommendation to include kidney function test (KFT) and blood pressure monitoring in the study volunteers to assess the safety, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organization (CDSCO) has granted approval to Intas Pharmaceuticals to conduct an Active Post Marketing Surveillance (PMS) Study of Tacrolimus Lipid Suspension for Enema 4 mg/vial in adult patients with mild to moderate left-sided ulcerative colitis refractory to Mesalamine.
This came after the firm presented their proposal for a grant of permission to conduct an Active Post Marketing Surveillance Study of Tacrolimus Lipid Suspension for Enema 4 mg/vial in adult patients with mild to moderate Left Sided Ulcerative Colitis Refractory to mesalamine before the committee.
An enema is a procedure where a liquid is introduced into the rectum and colon, typically to cleanse or empty the bowel, or to administer medication. Enemas are commonly used to relieve constipation, prepare for medical procedures like colonoscopies, or administer certain medications that can be absorbed by the colon.
Tacrolimus is an immunosuppressive drug whose main use is after organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It is also used in a topical preparation in the treatment of severe atopic dermatitis, severe refractory uveitis after bone marrow transplants, and the skin condition vitiligo.
Tacrolimus enemas are easy to prepare, well tolerated, effective, and safe. They should be included in the treatment armamentarium for inflammatory bowel disease‐related refractory proctitis.
At the recent SEC meeting for gastroenterology and hepatology held on 29th July, 2025, the expert panel reviewed the proposal presented by Intas Pharmaceuticals to conduct an Active Post Marketing Surveillance Study of Tacrolimus Lipid Suspension for Enema 4 mg/vial in adult patients with mild to moderate left-sided ulcerative colitis refractory to Mesalamine.
After detailed deliberation, the committee recommended the grant of permission to conduct the Active PMS study as per the protocol presented (Protocol No. 0287-23 ver 01 dated 20/01/2025) with the recommendation to include KFT and blood pressure monitoring in the study volunteers to assess the safety.
