The combination of Meropenem and Disodium EDTA as an injection is used to treat various bacterial infections.
This combination is administered via intravenous injection over a specific period, depending on the dosage prescribed by a healthcare professional. (Creative Commons)
The Drugs Controller General of India (DCGI) has written to the states about pharmaceutical companies manufacturing and marketing the broad-spectrum antibiotic Meropenem & Disodium EDTA for Injection, even though it has not yet received approval from the Central Drugs Standard Control Organisation (CDSCO).
The combination of Meropenem and Disodium EDTA as an injection is used to treat various bacterial infections.
These include pneumonia, urinary tract infections, intra-abdominal infections, gynaecological infections, skin infections, meningitis, and sepsis.
Meropenem is a broad-spectrum antibiotic that works by inhibiting the synthesis of cell walls in bacteria.
Disodium EDTA binds with calcium and some heavy metals in the body and is used to treat calcium overload and irregular heartbeats caused by certain medications like digoxin or digitoxin.
This combination is administered via intravenous injection over a specific period, depending on the dosage prescribed by a healthcare professional.
Common side effects may include headache, stomach pain, increased platelet count, diarrhoea, and allergic reactions like skin rash or swelling.
It is important to follow the prescribed dosage and consult a healthcare provider if any severe side effects occur.
“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’,” said Dr Rajeev Singh Raghuvanshi, Drugs Controller General, in his letter to the state drug controller on 8 March.
In the letter, he said that 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 ordering the withdrawal of the unapproved drugs immediately.
“Further, as per 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, 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,” said Dr Raghuvanshi.
He also directed the state authorities to convey the matter to all the manufacturers under their jurisdiction and cancel the product permission granted by them.
“The necessary information about the status and action taken in the matter may please be intimated to this Directorate at the earliest,” Dr Raghuvanshi added.
(Edited by Shauqueen Mizaj)
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