Zydus Lifesciences Directed to Revise PMS Study for Tofacitinib ER Tablets
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 decision comes after a detailed review during the committee meeting held on September 17, 2025, at CDSCO headquarters in New Delhi, where the firm presented its proposal seeking permission to conduct an Active Post-Marketing Surveillance (PMS) study.
- The SEC reviewed the study design and recommended changes to strengthen the protocol’s clinical robustness and safety monitoring parameters.
The firm had presented its proposal vide protocol No. C2B05724, before the committee.
Author summary: Zydus Lifesciences must revise PMS study.
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