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SEC rejects Abbott's proposal for clinical trial waiver for its antibiotic drug clarithromycin ER tablets

Gireesh Babu, New Delhi
Wednesday, May 15, 2024, 08:00 Hrs  [IST]

The Subject Expert Committee (SEC), which advises the central drug regulator regarding clinical trials and approvals of drugs, has once again rejected proposal from Abbott Healthcare Pvt Ltd (AHPL) for clinical trial waiver of its antibiotic formulation clarithromycin extended release (ER) tablets 1000 mg in the country.

The Committee, while considering the proposal, said that the proposed drug clarithromycin ER tablet 1000 mg at present is not approved anywhere in the world.

"The clarithromycin ER tablet 1000 mg had been approved in the year 2005. However, later on the same was withdrawn from US market due to unknown reason. Further, there is no specific unmet medical need of proposed formulation," observed the Committee for Antimicrobial and antiviral products in its meeting on May 9, 2024.

"After detailed deliberation, the Committee reiterated its earlier SEC recommendation to conduct phase-III clinical trials," it advised.

Accordingly, the firm should submit phase-III clinical trial protocol to the Central Drugs Standard Control Organisation (CDSCO) for further review by the committee.

It may be noted that AHPL has earlier approached the SEC with a proposal for grant of permission to manufacture and marketing of the formulation, along with the report for local clinical trial waiver. In a meeting held on May 31, 2023, the SEC rejected the proposal observing that the justification presented by the firm is inadequate for local clinical trial waiver.

"After detailed deliberation, the committee did not consider for clinical trial waiver and recommended that the firm should conduct BE study along with phase III clinical trial," it recommended during that meeting. It has also advised the company to submit phase III clinical trial protocol for further review by the committee.

In the latest meeting, the Committee noted that the company presented the BE report along with justification for waiver of phase III clinical trial.

The company currently sells Clarithromycin ER 500 mg formulations under the brand name Celex, a trademark which was earlier owned by GlaxoSmithKline Pharmaceuticals Ltd and was assigned to US-based Abbott Laboratories in April, 2002. AHPL is an affiliate of Abbott Laboratories, USA.

The company earlier this year lost a review application with the Department of Pharmaceuticals (DoP) against the retail price fixation of the drug Celex OD 500 mg tablets, after the Department upheld the National Pharmaceutical Pricing Authority's (NPPA) price fixation of the formulation.

AHPL argued that clarithromycin 500 mg in extended release/modified release dosage form is not a part of the revised Schedule-I notified with effect from November 11, 2022. Hence, the formulation 'Celex OD 500 mg 5's' must not be included in the calculation of the ceiling price for any other scheduled formulation. The current Schedule I of DPCO 2013 includes "Clarithromycin" specifically in the strengths of 250mg, 500mg, and 750mg only in the dosage form of conventional tablets, it argued.

NPPA argued that the modified release variants such as sustained release, controlled release, extended release, and prolonged release among others are an integral part of essential and lifesaving medicines and taking them out of price control is not the objective of Standing National Committee of Medicines (SNCM), which is relied upon for finalisation of the National List of Essential Medicine (NLEM), 2022.

The Review Authority accepted NPPA's logics and arguments and observed that when the MR is not mentioned separately, then all such varieties of such drugs for the specified dosages are considered to be part of variants appearing in the list.


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