The drug controllers from all major states of the country, in a meeting convened by the Drug Consultative Committee (DCC) recently, have come to a consensus to not to issue manufacturing licenses for new fixed doze combinations (FDCs) henceforth.
The decision comes in the wake of a long-standing plea from the DCC and the Drug Controller General of India (DCGI) to the state drug licensing officers to restrain from issuing licenses for irrational combinations and to be very cautious on the matter to ensure efficacy, rationality and quality standards of drug products licensed to be manufactured in their states.
Although the DCC could bring about such a consensus among the state drug controllers, according to Dr M Venkateswarlu, a senior member in the DCC and deputy drug controller of India (West Zone), an official directive in this regard is yet to be prepared. "With the present drug licensing structure in the country, it is difficult for the DCGI to issue an order for withdrawing/canceling licenses already granted by State departments," he said.
Even as the state departments have agreed in principle that not to issue licenses for new fixed doze combinations, the marketing and manufacturing of already licensed irrational combination products would continue unless the centre intervenes and take some stringent measures like banning the products in the country, which has happened in few instances earlier, he added.
However, in order to stop the entry of irrational combination products already licensed in the country, every state drug controllers can ban such products in their jurisdiction, he added. "But, having an ethical consideration while granting licenses to combination products is the most desirable solution to eliminate the proliferation of irrational drugs in the country and this has to be observed by all drug licensing authorities," said Dr Venkateswarlu.