News + Font Resize -

Gujarat FDCA all set to cancel post-2002 FDC licenses; awaiting DCGI order
Our Bureau, Mumbai | Tuesday, July 20, 2004, 08:00 Hrs  [IST]

The Gujarat Food & Drug Control Administration (FDCA) is all set to cancel all the 150 odd drug manufacturing licences it had issued for fixed doze combinations after May 2002, when Drug Control General of India (DCGI) issued a directive in this regard.

The FDCA Commissioner Dr Subodh P Adeshara said that though the Department had issued licenses for existing combination products even after the central directive in 2002, it is committed to cancel those licenses on its own at the moment the centre declares the product irrational or it instructs the states to withdraw such licenses issued after its first order, which came in May 2002.

However, he assured that Gujarat has never issued licenses for first time FDCs and had always asked the applicants to submit proof for the previous license of such combinations along with a Gujarat retail bill as evidence of the product availability in the state.

He added that the Department had issued licenses for existing FDCs after 2002 directive as it was forced to do so. This situation arises because the product is even otherwise available in the state with licenses from other states and he does not have the power to ban a product, which is licensed by a competent licensing authority of another state unless the product is declared irrational/banned by the centre.

Adeshara also pointed out that whenever his department has received a license application from the local manufacturer along with the stipulated documents such as the evidence for the first license etc, it has intimated to the DCGI for his approval before granting the license.

Post Your Comment

 

Enquiry Form