Laurus Labs Asked to Submit Justification, Data for Pediatric Darunavir-Ritonavir FDC Proposal
New Delhi: The Subject Expert Committee (SEC) on Antimicrobial & Antiviral under the Central Drugs Standard Control Organisation (CDSCO) has asked Laurus Labs Limited to submit additional scientific justification and clinical data in support of its fixed-dose combination (FDC) of Darunavir Ethanolate IP equivalent to Darunavir 120 mg + Ritonavir IP 20 mg film-coated tablets.
The matter was discussed during the 07th/25 SEC meeting held on 10th June 2025 at CDSCO headquarters in New Delhi. The firm presented its proposal along with a bioequivalence (BE) study report conducted for export purposes.
However, after detailed deliberation, the committee noted that the current submission lacked critical data and supporting literature. As per the official minutes,
“The firm did not present any scientific literature regarding essentiality and desirability of the FDC in proposed strength and indication.”
“The firm did not present any safety and efficacy data generated in Indian population for the proposed FDC.”
“Firm did not present any scientific literature/data from peer reviewed journal regarding the unmet need of the proposed FDC.”
“Firm did not present any justification for the proposed indication of the FDC in pediatrics population.”
Given these gaps, the SEC recommended that the company should submit the relevant data and justification for further regulatory review. It also specified that the evaluation should take place “in presence of experts from NACO.” (National AIDS Control Organisation)
The proposed combination of Darunavir, a protease inhibitor, and Ritonavir, used as a pharmacokinetic enhancer, is typically indicated for the treatment of HIV infection.
