24October2017

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DCG(I) in Bind Over FDC Licences

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 DTMT Network
The Drug Controller General of India Dr G N Singh has issued a notice calling upon all manufacturers of fixed dose combination drugs across the country to submit applications for clearance from the office of the DCG (I) of their licences given by state drug controllers. These applications are to be filed within two months. The notice is dated October 5, 2017.

This latest notice follows the earlier notice by the DCG(I) dated June 5, 2017, which gave time of four months for filing of such applications by manufacturers. The earlier notice had warned that if this was not done "their applications will not be considered and their licences  will be considered as without legal validity." However, the moment the four months elapsed, two more months have been given for the filing of applications.

The latest notice refers to a "pathway for clearance of cases" in respect of FDCs declared as "rational" by the Prof. Kokate Committee and approved by DCG(I).

The manufacturers who are holding licences from State Licencing Authority for such FDCs are being asked to apply for getting an NOC from DCG(I).

The latest notice by the DCG(I), however, is not very clear on whether the licences given by state authorities have lost their legal validity or not, or whether the DCG(I) is empowered to set aside the licence given by the state authorities.

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