The time line for submitting the efficacy data of FDC drugs - which were approved by the state drug controllers before October 1, 2012 -- to the Drug Controller General of India (DCGI) has ended with several companies still in the process of compiling the data.

According to the DCGI’s latest order, the last date for submitting the efficacy data of SLA - approved FDCs to the DCGI office has ended on September 30, 2013. “In case the applications of such FDCs are not submitted by any manufacturer by September 30, 2013, it will be presumed that they are not willing to prove the safety and efficacy of such FDCs before the office of the DCGI,” the DCGI order to the state licensing authorities (SLAs) said.

In January this year, the DCGI Dr GN Singh had directed the State drug controllers to ask the concerned manufacturers to prove the safety and efficacy of such FDCs within 18 months, failing which such FDCs will be considered for being prohibited for manufacture and marketing in the country.

But till June this year, hardly any such manufacturers had approached the CDSCO to prove the safety and efficacy of such FDCs, forcing the DCGI to revise the deadline given to the manufacturers in this regard. Annoyed by the poor response to his January directive to submit safety and efficacy data of FDC drugs approved by the state drug controllers before October 1, 2012 without his office's approval, the DCGI in July this year issued a new directive, asking the manufacturers of such FDC drugs to submit the application for such FDCs before August 30 this year.

Alarmed over the DCGI’s new directive, several industry associations in the country urged the DCGI to extend the last date of submission till March 31, 2014 as proposed earlier. The industry associations in their submission to the DCGI pointed out that the extension of last date for submission of safety and efficacy data for SLA-approved FDCs is necessary in view of the extensive nature of effort and time required in compiling and submitting the necessary details.

After considering the associations demand, the DCGI decided to extend the deadline by only one month till September 30, 2013.