23 new fixed dose combinations (FDCs) have been granted licences by state authorities without mandatory approval of the Drug Controller General of India and action will be taken in these cases, Government said today.
"In twenty three cases of new fixed dose combinations, licences have been granted by the State Licencing Authorities (SLAs) without the mandatory approval of the DCG(I)," Minister for Health and Family Welfare Ghulam Nabi Azad told the Lok Sabha in a written reply.
He said, "the State Drug Controllers have been asked to take action under the Drugs and Cosmetics Act, 1940 in all these cases."
The Minister said the central government has issued instructions to all state/UT governments not to grant licences to new drugs for manufacture for sale or for distribution or for export of such new drugs, except in accordance with the laid procedure without the approval of DCGI.
