The conflicting claims over the purity of Grastim (filgrastim) of Dr Reddys Laboratories Ltd (Dr Reddys) alleged by Nicholas Piramal India Ltd (NPIL) seems to have come to a close with the final observations of the expert committee appointed by the Office of the Drugs Controller General of India (DCGI) concluding that Grastim and Neupogen (the branded product of Roche which is being marketed by NPIL) has been tested similar in its purity and efficacy profiles.

The final report, which is ready with the expert panel headed by Dr Ganguly, says that the tests conducted on the market samples of both the drugs in two government laboratories have both shown identical expressions in amino assay, nucleotide sequence and in their respective physical and chemical properties. Purity levels of both the products have found to be satisfactory.

The panel is to officially place the report before the representatives of both the companies at a meeting scheduled on January 16, it is learnt.

According to highly placed sources, the report is to ask Dr Reddys to change the name "Grastim" into something, which do not resemble the generic non-proprietary name.
It is known that the decision would pave way for biogenerics being accepted as an entity by itself in future.

NPIL - Dr Reddys controversy broke out after NPIL contested Dr Reddys claim that Grastim has the same clinical profile as Neupogen, a drug imported from Swiss-based F. Hoffmann La Roche and marketed in India by NPIL.