Generation Of CMC Data At More Than One Manufacturing Unit

To ease the overall drug license registration process, CDSCO has now allowed manufacturers to use existing CMC data for their new manufacturing facilities of the same drug. This is a good step towards easing the registration process and encouraging pharma companies to expand in India.

For a long time, CDSCO has been pondering over existing norms related to CMC data and license approval requirements for manufacturing a new drug by a manufacturer in an additionally owned site.

Recently, the CDSCO has drafted some provisions allowing a drug manufacturer to produce a drug in their additional manufacturing units using the existing CMC data. However, the manufacturer must establish similarity through technology transfer concerning the manufacturing process.

In addition to the technology transfer, some other conditions must be established between the added manufacturing site and the already approved site. Which include

●       The equipment used at both manufacturing sites must be same in configuration

●       All the parameters of the process and its capability must be the same

●       Bridging validation for transfer of technology

In the latest circular, the DGCI stated that the manufacturer should obtain a license or permission from the required authority for generating the CMC (chemistry, manufacturing, and control) data.

It also stated that the particular matter has been examined properly and it has been decided that if the manufacturer has generated CMC data in one of its manufacturing sites. Which is the basis of approval for obtaining the license to manufacture a new drug in the same facility. The same CMC data can be used by the manufacturer for manufacturing the same drug in its other manufacturing site without additional CMC data approval. Given that all additional required permissions are obtained.

However, the particular manufacturer proves the similarity among such units by technology transfer concerning the manufacturing process along with other prerequisites as well as standard operating procedures.

What is CMC data and its relevance here

CMC stands for Chemistry, Manufacturing & Controls. This data is a collection of the facts, figures and information related to the quantitative, analytical and qualitative composition of a new pharmaceutical drug for testing, analysis, manufacture and license approval.

CMC is an important part of the drug development life cycle after its discovery. CMC data describes the drug in a detailed manner and provides relevant data for scaling up the production to larger batches along with defining stability.

Earlier, CDSCO required each new manufacturing facility to submit the CMC data for license registration for a drug. Even if the manufacturing license for it at other production premises had already been approved. This caused unnecessary delays in production and hindered the growth of the Indian pharmaceutical market.

This was also quite inappropriate since in layman terms CMC data can be seen as a recipe for manufacturing and preservation of a drug.