The Central Drugs Standard Control Organization (CDSCO) has have issued a warning regarding the manufacturing and marketing of Meropenem 1gm + EDTA for Injection. This notice was dated April 16, 2024.
In its notice, the CDSCO has stated that it has become aware that some manufacturers are producing and marketing Meropenem 1gm + EDTA for Injection. This drug has not been officially approved for manufacturing or marketing in India and is classified as a “New Drug” under Indian regulations.
Regulations for New Drugs
Manufacturing and Sale Restrictions
As per the New Drugs and Clinical Trial Rules, 2019, no new drug can be manufactured for sale without approval from the Licensing Authority.
Additionally, Rule 80 of these rules also specifies that any entity intending to manufacture a new drug, either as an Active Pharmaceutical Ingredient (API) or a pharmaceutical formulation, must submit an application for permission using Form CT-21 and pay the required fee.
This notice is intended to inform all stakeholders involved in the pharmaceutical industry, including manufacturers, distributors, and healthcare professionals.
This notice highlights the importance of using only approved medications to ensure patient safety. It also serves as a reminder to manufacturers and distributors to comply with established drug regulations.
