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SEC Rejects Abbott's Proposal for Clinical Trial Waiver on Clarithromycin ER Tablets

In a recent development, the Subject Expert Committee (SEC), tasked with advising the central drug regulator on clinical trials and drug approvals has rejected  Abbott Healthcare Pvt Ltd’s (AHPL) application for a clinical trial waiver for its antibiotic formulation, clarithromycin extended-release (ER) tablets 1000 mg in India.

During a recent meeting, the Committee reviewed the company’s proposal and identified many serious issues, including criticising the proposed clarithromycin ER tablet 1000 mg for lack of global regulatory approval and unmet medical necessity, having been certified in 2005 but withdrawn from the US market.

"After detailed deliberation," remarked the Committee for Antimicrobial and Antiviral Products, "the committee reiterated its earlier SEC recommendation to conduct phase-III clinical trials."

It may be noted that this decision aligns with the SEC's stance during a previous meeting on May 31, 2023, where a similar proposal from AHPL was rejected due to insufficient justification for a local clinical trial waiver.

According to the SEC's recommendation, AHPL must now proceed with phase III clinical trials and submit the trial plan to the Central Drugs Standard Control Organisation (CDSCO) for additional consideration. Despite AHPL's provision of a bioequivalence (BE) study and grounds for the waiver of phase III clinical trials, the SEC maintains its stance.

It's worth noting that AHPL, an affiliate of US-based Abbott Laboratories, is no stranger to regulatory challenges. Earlier this year, the company faced setbacks in its dispute with the Department of Pharmaceuticals (DoP) over the retail price fixation of its drug Celex OD 500 mg tablets.

Despite AHPL's objections to adding clarithromycin 500 mg extended-release formulations in price fixation calculations, the DoP backed the National Pharmaceutical Pricing Authority's (NPPA) decision, underlining the significance of limiting costs for vital and lifesaving medications.

In light of these developments, the SEC's advice emphasises the necessity of careful review and compliance with regulatory standards in medication approval processes. As AHPL works through these regulatory challenges, the future of clarithromycin ER tablets remains unknown, pending additional clinical trials and regulatory evaluation.

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