Drug regulator warns about Meropenem, Disodium

CDSCO warns against unapproved drugs, specifically "New Drugs", citing examples of Meropenem and Disodium EDTA.

The Central Drugs Standard Control Organisation (CDSCO) has cautioned against the manufacture and sale of unapproved drugs specifically warning against drugs falling under the category of “New Drugs”.

The organisation citing the example of drugs – Meropenem (antibacterial agent) and Disodium EDTA (to treat calcium overload) – noted that they have got information that some manufacturers are involved in manufacturing/marketing of unapproved drugs which CDSCO does not yet approve.

In its communication to all zonal/sub-zonal offices of CDSCO and the Indian Drugs/Pharmaceutical Association forum, it said that no new drug shall be manufactured for sale unless the licensing authority approves it and additionally a person who intends to manufacture a new drug in the form of Active pharmaceutical ingredients (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 as per the specifications.

CDSCO has now directed that all manufacturers be made aware of the two drugs – Meropenem and Disodium EDTA. “The matter should be conveyed to all manufacturers and the product permission granted by these drugs should be cancelled,’’ it noted.