The document, available here , covers the requirements for approval of trials, new drugs and details the CDSCO’s review process under Rule 122A, 122B, 122DA,122DAA,122E and Schedule-Y of the Drugs and Cosmetics Rule.
The organisation said that: “This guidance will help the industry to submit the required documents in a more realistic manner, which in turn will also help reviewer of CDSCO to review such application in systematic manner.
“It is apparent that this structured application with comprehensive and rational contents will help the CDSCO to review and take necessary actions in a better way and would also ease the preparation of electronic submissions, which may happen in the near future at CDSCO.”
The issuance of the new document, which covers the differing requirements for clinical trials for drugs discovered in India compared with those discovered elsewhere, follows just a month or so after the CDSCO updated its rules on adverse events during studies .
Import export APIs
In addition the new guidance, issued during a busy week for the CDSCO regulatory team, clarifies the organisations rules on the importation of active pharmaceutical ingredients (APIs) for both clinical trials and the market.
It specifies that applicants importing small quantities of APIs for clinical trials under the Form 11 registration process must also provide a Form 12 approval document.
Similarly, manufacturers can produce small quantities of API for trials provided that the have obtained a Form 29 license issued by state authorities.
The document also advises that applicants seeking to obtain APIs for trials from a third party manufacturer not yet approved by the DCGI need the supplier in question to seek a DSCO no objections certificate (NOC).