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DCGI informs SLAs antibiotic combo meropenem 1 mg & EDTA for injection has no CDSCO approval

Apr 18,2024

The Drugs Controller General (India) (DCGI) has informed all state drug regulators that the Central regulatory authority has not approved manufacturing and marketing of antibiotic combination of meropenem 1 mg and EDTA for injection and it is against the rules to produce and sell the drug without its approval.

The drug regulator said that it has come to its notice that some manufacturers are involved in manufacturing and marketing the combination, which is not yet approved by the Central Drugs Standard Control Organisation (CDSCO) for manufacturing or marketing in the country and falls under the category of new drug.

DCGI Dr Rajeev Singh Raghuvanshi in a notice to all the concerned stakeholders said, “No new drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined in Rule 3 of New Drugs and Clinical Trial Rules, 2019”.

Further, as per Rule 80 of New Drugs and Clinical Trial Rules, 2019, a person who intends to manufacture new drug in the form of active pharmaceutical ingredient (API) or Pharmaceutical formulation, as the case may be for sale or distribution, shall make an application for grant of permission to the Central Licensing Authority in Form CT-21 along with a fee as specified in Sixth Schedule.

It may be noted that last month, the DCGI has directed the state drug regulators in the country to cancel the product permission granted by them for manufacturing and marketing of certain antibiotic drug combination meropenem and disodium EDTA for injection since it is a new drug and needs approval from the Centre also.

The DCGI during the time said that it has come to the notice of the CDSCO that some manufacturers are involved in manufacturing and marketing of unapproved drugs which is not yet approved by his office for manufacturing or marketing in the country and falls under the category of new drug.

“…you are hereby directed to convey the matter to all the manufacturers under your jurisdiction and cancel the product permission granted by you of the subject drug,” said the DCGI. The necessary information about the status and action taken in the matter may be intimated to the CDSCO at the earliest, he added.

According to the online trading portals, the drug combination meropenem and disodium EDTA for injection is sold by a manufacturer as an ultra broad spectrum antibiotic and claimed as effective and well-tolerated for the treatment of infections including bacterial meningitis, lower respiratory tract infections and used in treatment of certain types of cancer. 

Source: Pharmabiz

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