The Union health ministry will soon amend a provision under Schedule Y of the Drugs & Cosmetics Rules, 1945 regarding the authenticity of the clinical data or documents submitted by the applicant companies.
A decision to this effect was taken by the Drugs Technical Advisory Board (DTAB) at its 68th meeting held recently. In the meeting, the DTAB members were briefed that the note under Schedule Y provides only authentic data should be submitted for the application for permission to import and manufacture new drugs for sale or to undertake clinical trials. The data is required to be self certified. It also provides the licensing authority the right to reject any data or any document if such data or content of such documents are found to be of doubtful integrity.
It was also taken into consideration that the above provision does not explicitly provide for the administrative action which could be taken in the case any data or documents submitted is found to be of doubtful integrity.
It is, therefore, proposed that the note may be amended to read as- "The data requirements stated in this schedule are expected to provide adequate information to evaluate the efficacy, safety and therapeutic rationale of new drugs (as defined under rule 122-E) prior to the permission for sale. Depending upon the nature of new drugs and disease, 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 of India (DCGI) as the case may be if such data or contents of such documents are found to be of doubtful integrity."
The DTAB, which is the highest authority under the Union health ministry on technical matters, after deliberations agreed to the proposed amendment.