DCGI to SLAs: Cancel this Antibiotic Drug Combination

March 13, 2024

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DCGI CDSCO Regulator Drugs Controller General India — DCGI

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Last Updated on June 7, 2024 by The Health Master

Drug Combination

In a recent development, the Drugs Controller General of India (DCGI) has issued a directive to the state drug regulators across the nation to revoke the product permissions granted for the manufacturing and marketing of a specific antibiotic drug combination—meropenem and disodium EDTA for injection.

This action is prompted by the fact that the drug combination in question is classified as a new drug and thus requires approval from the central regulatory authority as well.

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The Authority’s Stand: DCGI’s Statement

DCGI Dr. Rajeev Singh Raghuvanshi emphasized that certain manufacturers have been found to engage in the production and distribution of unapproved drugs.

These drugs, lacking approval from the central regulatory body, fall under the category of new drugs as per the existing regulations.

Legal Framework: Rules Governing New Drugs

Under Rule 3 of the New Drugs and Clinical Trial Rules, 2019, no new drug can be manufactured for sale unless it receives approval from the licensing authority.

Additionally, Rule 80 outlines the procedure for obtaining permission to manufacture new drugs, requiring applicants to submit specific forms and fees to the Central Licensing Authority.

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Directive to State Drug Controllers

The directive issued by the DCGI instructs state and union territory drug controllers to notify manufacturers within their jurisdictions about the cancellation of product permissions for the aforementioned drug combination.

It also stresses the importance of promptly informing the Central Drugs Standard Control Organisation (CDSCO) about the status of these actions.

Implications of this Drug combination

The antibiotic combination of meropenem and disodium EDTA is marketed as an ultra-broad-spectrum antibiotic, claimed to be effective and well-tolerated for treating various infections, including bacterial meningitis, lower respiratory tract infections, and certain types of cancer.

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Regulatory Concerns

This incident sheds light on recurring issues concerning the manufacturing and marketing of unapproved drugs in India.

Experts attribute these lapses to communication gaps between regional and central drug regulatory authorities, among other factors.

Calls for Centralized Regulation

The Drugs Technical Advisory Board (DTAB) has recommended to the Drugs Consultative Committee (DCC) the exploration of a unified licensing or approval authority nationwide.

This suggestion comes in the wake of discussions regarding a centralized drug regulatory mechanism, particularly following adverse incidents involving Indian-made medicines abroad.

Need for Information Sharing

Experts advocate for the establishment of a single national portal where state drug regulators can update information regarding drug licenses and quality test results.

This centralized repository would enable the national drug regulator to access pertinent information efficiently.

Lessons from Past Efforts

Previous endeavors to address issues such as irrational fixed-dose combinations (FDCs) in the country have highlighted the approval of several FDCs by state or union territory regulatory authorities without central approval.

This underscores the necessity for a more coordinated and centralized approach to drug regulation.

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