Even as the last date for submitting the efficacy data of FDC drugs approved by the state drug controllers before October 1, 2012 to the Drug Controller General of India (DCGI) ends on August 30, the pharma industry in the country has urged the DCGI to extend the last date of submission till March 31, 2014 as proposed earlier.
The industry has 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.
Besides, the industry has informed the DCGI that the extension of last date for submission of safety and efficacy data is necessary, otherwise there will be an adverse impact on the availability of these FDC drugs in the country. The industry's fear in this regard stems from the fact that several state drug authorities have threatened to cancel the licenses or renewals if the manufacturers fail to submit the safety and efficacy data of the FDC drugs approved by the state drug controllers before October 1, 2012 by August 30 as was directed by the DCGI.
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.