Approval must for obtaining drug licence, says DCGI

Tribune News Service

Solan, May 19

Drug Controller General of India (DCGI) Dr GN Singh today directed the state drug controller to ensure that licence for manufacturing new drugs, including those falling in the fixed doze combination (FDCs), should not be granted without their approval as cases of such approvals from the states were being received.

While some manufacturing states were granting licences for new drugs, including FDCs, the DCGI said this practice was not in conformity with the law and it could have disastrous consequences. The officials of the state drug department have also been directed to ensure that if such licences had been issued, they should be cancelled and a report should be sent to him detailing the same. The grant of manufacturing licence for new drugs, including FDCs, has been a controversial issue as the drug authorities of some states have been granting such licences on their own. While manufacturers who failed to get such licences have been raising voice against it, the fresh directions from the DCGI will put an end to this ambiguous situation.

Drug Controller Navneet Marwaha while confirming the news said a copy of such directions had been received from the DCGI, adding that they would be strictly complied with. The issue was also raised by the state Health Minster before Union Health Minister JP Nadda during his recent visit to the Baddi area.