DCI sets up expert group to look into DRL Grastim claims

Anju Ghangurde

Mumbai, Oct 15: The Drugs Controller General of India (DCI) has directed Dr Reddy’s Laboratories (DRL) to desist from using the word “Filgrastim” in the package inserts (PIs) and other literature of its anti-cancer drug, Grastim, till an expert group looks into the issue of whether Grastim is identical to Filgrastim.

In the interim, DRL has been asked to restrict itself to the description of the drug —-human recombinant Granulocyte Colony Stimulating Factor. DRL has, however, made a representation to the DCI to reconsider the matter.

The latest move comes after Nicholas Piramal (NP) had earlier made submissions to both the Monopolies & Restrictive Trade Practices Commission (MRTPC) and the DCI alleging that DRL’s Grastim is not Filgrastim at all.

NP’s allegations are in line with supporting facts, from Swiss giant, F Hoffmann-La Roche, which highlight the amino acid sequence and the molecular weight of Neupogen, the original Filgrastim. “Any other protein with a different amino acid sequence and molecular weight cannot be called Filgrastim,” a letter from Roche says.

NP had claimed that DRL’s Grastim’s amino acid sequence, molecular weight and retention time (which indicates the purity of the compound) are at variance, forcing NP to allege that Grastim is not Filgrastim, but possibly a new drug altogether. This variance would mean that Grastim may actually be different protein in the G-CSF family.

DRL executive vice-president (emerging businesses) Dr Jayaram Chigurupati,in response to queries from The Financial Express said: “The DCI has communicated to us the setting up of an expert group to go into the question of whether Grastim is identical to Filgrastim. Along with our drug licence application, we had submitted our draft label, which identified the drug as Filgrastim, which is the international non-proprietary name of recombinant human granulocyte colony stimulating factor produced in E coli.”

Dr Chigurupati added that NP has claimed to the DCI that Grastim is not Filgrastim because of three alleged differences between Grastim and Neupogen. “We believe that the allegations made by NP are either false or misleading. We believe that none of these parameters have actually been tested by NP before making the allegations,” he said. A NP official said, “ The data given by DRL is under oath.
Besides there is an extra band in Grastim compared with Neupogen which may mean impurities in DRL’s product.”

DRL also claims that it has conducted extensive tests on Grastim and Neupogen comparing them on several parameters and “we can categorically state that both products are Filgrastim.” All the comparative tests have been submitted to the DCI along with the original application.

Dr Chigurupati added that DCI has directed DRL to restrict itself to the description of the drug —human recombinant granulocyte colony stimulating factor — rather than its international non-proprietary name, Filgrastim, till the expert group can take a view on the matter.
However, while the Filgrastim corporate battle rages on, little is being said or done to monitor how patients on the drug are faring in the interim. “Finally, it’s the patient that matters,” an analyst added.