The authorities have clarified that fixed dose combinations (FDCs) for veterinary use are exempted from the purview of the controversial order by the Drugs Controller General of India (DCGI) to prove safety and efficacy within a stipulated time-frame.
The clarification comes in the wake of representations made by the manufacturers of FDCs for veterinary use, following the DCGI order in January this year which asked the manufacturers of FDCs, approved without prior permission of the DCGI, to prove safety and efficacy before September 30.
“Manufacturers have requested exemption of requirements of proving safety and efficacy of FDCs as issued by this office latter no 4-01/2013-DC dated 15-01-2013 within a period of 18 months before the office of the DCGI, licensed by state licensing authorities without prior approval of the DCGI,” a notice by DCGI Dr G N Singh said.
“With the concurrence of the Ministry of Health and Family Welfare, it is hereby clarified that the letter issued by this office is with respect to the fixed dose combinations for human use. It does not cover the fixed dose combinations for veterinary use,” it said.
“However applications of fixed dose combinations of veterinary products received by CDSCO would be examined separately on routine basis in consultation with the Department of Animal Husbandry, Dairying and Fisheries, Ministry of Agriculture and Cooperation as practised for any new veterinary product,” the notice added.
The directive to file safety and efficacy data on FDC drugs approved by the state licensing authorities before October 1, 2012 without prior permission of the DCGI, however has been stayed by the High Court of Himachal Pradesh, even as the deadline of September 30 passed off without raking much response from the manufacturers.
As per the DCGI order, if the manufacturers failed to submit the data before the deadline, these FDCs would be considered for being prohibited for manufacture and marketing in the country. “In case the applications of such FDCs are not submitted by any manufacturer by September 30, 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.