The Union HealthMinistry will soon amend the Note under Schedule Y (REQUIREMENTSAND GUIDELINES FOR PERMISSION TO IMPORT AND / OR MANUFACTURE OF NEW DRUGS FORSALE OR TO UNDERTAKE CLINICAL TRIALS) of the Drugs and CosmeticsRules, 1945 regarding the authenticity of the data or documents submitted bythe applicant. The Note under Schedule Y provides that only authentic data should be submittedfor the application for permission to import and/or manufacture of new drugsfor sale or to undertake clinical trials. The data is required to be selfcertified. It also provides the licensing authority reserves the right toreject any data or any document(s) if such data or content of such document arefound to be of doubtful integrity.However, the above provision does not explicitly provide for the administrativeaction which could be taken in case any data on documents submitted is found tobe 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 adequateinformation to evaluate the efficacy, safety and therapeutic Rational of newdrugs (as defined under Rule 122-E) prior to the permission for sale.  Dependingupon the nature of new drugs and disease(s), additional information may berequired by the Licensing Authority. The applicant shall certify theauthenticity of the data and documents submitted in support of an applicationfor new drug. The Licensing Authority reserves the right to reject any data orapplication or debar the applicant for a specific period to make anyapplication to the office of Drugs Controller General (I) as the case may be ifsuch data or contents of such documents are found to be of doubtfulintegrity."The came up for discussion during the recently held Drugs Technical Advisory Board(DTAB) meeting. The DTAB after deliberations agreed to the proposed amendment.

Reference: Agenda No.S-3 of DTAB 68th meeting report (as attached).