The Union Health Ministry will soon amend the Note under Schedule Y of the Drugs and Cosmetics Rules, 1945 regarding the authenticity of the data or documents submitted by the applicant.
The Note under Schedule Y provides that only authentic data should be submitted for the application for permission to import and/or manufacture of new drugs for sale or to undertake clinical trials. The data is required to be self certified. It also provides the licensing authority reserves the right to reject any data or any document(s) if such data or content of such document are found to be of doubtful integrity.
However, the above provision does not explicitly provide for the administrative action which could be taken in case any data on documents submitted is found to be of doubtful integrity.
It is therefore proposed that the note may be amended to read as: "Note.- The data requirements stated in this Schedule are expected to provide adequate information to evaluate the efficacy, safety and therapeutic Rational of new drugs (as defined under Rule 122-E) prior to the permission for sale. Depending upon the nature of new drugs and disease(s), additional information may be required by the Licensing Authority. The applicant shall certify the authenticity of the data and documents submitted in support of an application for new drug. The Licensing Authority reserves the right to reject any data or application or debar the applicant for a specific period to make any application to the office of Drugs Controller General (I) as the case may be if such data or contents of such documents are found to be of doubtful integrity."
The came up for discussion during the recently held Drugs Technical Advisory Board (DTAB) meeting. The DTAB after deliberations agreed to the proposed amendment.