The Directorate General of Health Services (DGHS) has issued a notice regarding the manufacturing and marketing of unapproved drugs by certain manufacturers. These drugs have not yet been approved by the office for manufacturing or marketing in the country and are categorized as “New Drugs.” This notice is dated March 8, 2024.
According to the rules outlined in the New Drugs and Clinical Trial Rules of 2019, no new drug can be manufactured for sale unless it is approved by the Licensing Authority. Rule 80 of the same regulations specifies that any person intending to manufacture a new drug must obtain permission from the Central Licensing Authority through an application made in form CT-21.
In light of these regulations, all manufacturers are directed to cease the production of Meropenem and Disodium EDTA for injection immediately. Additionally, the product permissions granted for these drugs will be canceled without delay.
State authorities are urged to convey this directive to all manufacturers and ensure compliance with the regulations. Furthermore, they are requested to provide updates on the status of the matter and actions taken to the Directorate General of Health Services promptly.
This measure aims to uphold safety standards and ensure that only approved drugs are available for sale and distribution in the country, safeguarding public health and well-being.
