New Delhi: Pune-based Emcure Pharmaceuticals Ltd has received a recommendation from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase IV clinical trial of Drospirenone Tablets 4 mg, a hormonal contraceptive approved for use in women of reproductive age.

The recommendation came during the SEC meeting held on September 18, 2025, at CDSCO Headquarters, New Delhi.

As per the condition attached to the product’s earlier manufacturing and marketing permission, the company presented its Phase IV post-marketing clinical trial protocol titled “A Multicentric, Open-Label, Single-Arm, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of Drospirenone Tablets 4 mg for Oral Contraception in Women of Reproductive Age” (Protocol

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