The Requirement Of Cmc Documents For Approval Of Additional Manufacturing Facility For An Already Approved Drug Product.

 

The Drugs Controller General of India or DCGI has approved to manufacture new drugs in an additional facility of a manufacturer but on a condition. The manufacturer has to establish similarity through technology transfer in respect to the manufacturing process. In addition to technology transfer, conditions also involve equipment, process capability, bridging validation as well as process parameters. This all is required for transfers between proposed additional manufacturing sites and the site that has been already approved.

It has been quite a time now when such requirements for the manufacturing of any novel drug in an additional site of a manufacturer has been under discussion. Thus, in a circular DCGI stated to all stakeholders that all manufacturers should obtain license or permission from the required authority for generating chemistry, manufacturing and control or CMC documents. Based on the given CMC documents by the manufacturer, approval or permission will be granted for manufacturing a new drug in a manufacturing facility. However, the manufacturer still has to comply with the drug license application process.

This data can also be used by the manufacturer for manufacturing the same product in the other manufacturing site with the required license. The same is also based on a condition that the manufacturer established similarity through technology transfer concerning the process of manufacturing among all other requirements as well as SOPs.

CDSCO has also made it mandatory for all state drug controllers to submit a real-time stability study on the drug for its first three batches as per Drug Consultative Committee recommendation. The 53rd meeting on April 9 by DCC had made a recommendation that all manufacturers are needed to make sure about the stability of every drug before granting license so that all patients get best quality medicines as per Drugs and Cosmetics Act.

Stability data offers evidence on how the quality of a drug differs with time because of environmental influence like temperature, light and humidity. So, as per the regulations, stability data should be submitted by all companies who are applying for a manufacturing license. It is a detailed observation of six months of any particular medicine for which a manufacturing license is granted.