Dr Reddys Yet To Erase Filgrastim From Grastim Packs

Dr Reddy's Laboratories is yet to remove the word 'filgrastim' from its anti-cancer drug Grastim in compliance with the order issued by the Drug Controller General of India (DCGI).

Leading hospitals in Mumbai and Delhi have batches of the drug with the 'filgrastim' appearing on the outer pack of the injection vial and on the product insert with the vial.

This is despite the DCGI order dated October 15, 2001, asking the company to substitute the word with 'human recombinant granulocyte colony stimulating factor (G-CSF)'.

DCGI had further stated that human G--CSF marketed by Dr Reddy's is not the same as filgrastim for various reasons such as the difference in the chain of amino acids in Hoffman La Roche's Neupogen (filgrastim) and Grastim. The molecular weight of the two also differ.

 

Also, the order said, the various clearances given by the Genetic Engineering Approval Committee (GEAC) and DCGI is for human recombinant G-CSF injection, and not filgrastim. Therefore, the name on the product too must be changed.

Responding to queries from Business Standard, a Dr Reddy's spokesperson said: "The DCGI had directed us to restrict ourselves to the description of the drug, namely human recombinant granulocyte colony stimulating factor, rather than in its international non-proprietary name, filgrastim, till the expert group can take a view on the matter. We made a representation to the DCGI to reconsider the matter since we believe that their directive was based on false and misleading information furnished to them by Nicholas Piramal. Our representation is under consideration by the DCGI."

"Along with our drug license application we had submitted our draft label, which identified the drug as filgrastim. Filgrastim is the international non-proprietary name of recombinant human granulocyte colony stimulating factor produced in E.coli. We are statutorily obliged to use the international non-proprietary name published by the WHO, which in this case is filgrastim," he added.

Meanwhile, Nicholas Piramal is compiling data requested by the expert committee to prove its claim.