Zydus Lifesciences Told To Revise PMS Study For Tofacitinib ER Tablets
New Delhi: Zydus Lifesciences Ltd. has been directed by the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) to revise its Post-Marketing Surveillance (PMS) study protocol for Tofacitinib Extended-Release Tablets 11 mg.
This comes following a detailed review during the committee meeting held on September 17, 2025, at CDSCO headquarters in New Delhi.
The firm had presented its proposal seeking permission to conduct an Active Post-Marketing Surveillance (PMS) study for Tofacitinib Extended-Release Tablets 11 mg, vide protocol No. C2B05724, before the committee. After thorough evaluation, the SEC reviewed the study design and recommended a series of changes to strengthen the protocol’s clinical robustness and safety monitoring parameters.
Following deliberation, the committee recommended that the study duration be extended to nine months, and the number of subjects be increased to at least 300 patients, ensuring participants are distributed equally among three approved indications. The committee also advised that the validated outcome measures be appropriately increased to demonstrate both safety and efficacy outcomes.
Additionally, the SEC instructed the firm to include screening for Latent Tuberculosis Infection (LTBI), HIV, and Hepatitis C, and to add serum procalcitonin estimation in the study protocol to enhance safety assessments. The firm has been asked to submit the revised PMS protocol to CDSCO within 15 days for further review by the committee.
Tofacitinib Extended-Release Tablets 11 mg is an oral formulation used for treating rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. The extended-release form allows once-daily dosing, aiding patient adherence and consistent therapeutic effect.
