Drugs controller orders immediate withdrawal of unapproved anti-bacterial drug

Meropenem helps to treat bacterial infections by killing the bacteria.

The Central Drugs Standard Control Organisation (CDSCO) has issued an alert against the unapproved use of meropenem and disodium EDTA injections and has instructed for its withdrawal.

Meropenem helps to treat bacterial infections by killing the bacteria. It is sold as a broad-spectrum antibacterial agent in India currently. The combination of drugs is used to treat pneumonia, urinary tract infections, intra-abdominal infections, gynaecological infections, skin infections, meningitis, and sepsis. It prevents the formation of the bacterial protective cell wall, which is required for bacteria to survive.

The letter issued by the CDSCO says that, “It has been brought to notice of this Directorate that some manufacturers are involved in manufacturing/marketing of unapproved drugs which is not yet approved by this office for manufacturing/marketing in the country and falls under the category of "New Drug".”

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According to Rule 80 of New Drugs & Clinical Trials Rules 2019, a person who intends to manufacture a new drug in the form of API or pharmaceutical formulation, for sale or distribution, should make an application for permission to the Central Licensing Authority in Form CT-21 along with a fee as specified in the Sixth Schedule.

In a letter addressed to the zonal and sub zonal offices of the CDSCO and the Indian Drug/Pharmaceutical Association Forum, the Drugs Controller General of India (DCGI), Dr. Rajiv Singh Raghuvanshi has issued instructions to convey the matter to all manufacturers under their jurisdiction and cancel the product permission granted by the zonal offices if any.

“The necessary information about the status and action taken in the matter may please be intimated to this Directorate at the earliest,” the public notice added.