The Drug Controller General of India's (DCGI's) office is reworking the timeline for approvals fixed in last July for disposal of various approval applications with the authority. The authority has also initiated efforts to streamline its approval process on the pending cases, on applications filed prior to January 1, 2009, for speedy disposal.

The timelines for disposal of various applications made to DCGI office are under study and revision at present. The process is to bring in slight changes in the timeline issued by the DCGI in July, in order to rationalise the working hours, according to official sources.

The revised timeline will be calculated excluding the weekend holidays for the office, from the deadline fixed for disposal of an application from the date of filing. At present, the weekend holidays and special holidays also accounts with the timeline fixed for various approvals. For instance, a timeline fixed as two weeks for approvals currently includes the weekend holidays even as the revised timeline for the same application would be 15 or 16 days to compensate the weekend holidays within this period.
The DCGI, in July, fixed timeline for disposal of applications for Export No Objection Certificate as two weeks, dual use, rule 37 and neutral code as three weeks, additional indication and similar applications as four weeks, disposal of Form 10 as four weeks and test licence as four weeks from the date of filing of application.

Further, the disposal of first response to new drug applications and Fixed Dose Combination should be carried out within six weeks along with timeline of disposal of Bioequivalence study for export purposes within six weeks, endorsement of additional products on registration within eight weeks and registration of products within 12 weeks from the time of receiving the application.

Along with the revision of the timeline for approvals, the streamlining process of pending approval cases is also carried out to speed up the disposal of backlog files. The DCGI's office has notified that the applicants, who have filed for various approvals with the office prior to the beginning of current year, should represent their cases to the authority till September 10, 2009.

The effort is to streamline the pending approval cases with the office and to speed up the disposal of backlog files after collecting adequate response from the applicants. A notice regarding this has been issued by the authority on Monday with a format for the interested parties to respond.

The applicant should submit the latest status of their pending case including the latest dairy number of application, the status of queries and responses with the authority etc. The notice also states that the applicants who want to have personal hearing with the authority may indicate the purpose along with the format.