MRTPC adjourns hearing on DRL-NP row over filgrastim

Our Corporate Bureau

Mumbai, Oct 3: Nicholas Piramal (NP) on Wednesday made a plea to the Monopolies and Restrictive Trade Practices Commission (MRTPC) urging it to direct Dr Reddy’s Laboratories (DRL) to delete the word ‘filgrastim’ from its product insert (PIs) for anti-cancer drug, Grastim. The hearing has been adjourned for 15 days.

NP had earlier made submissions to both the MRTPC and the Drugs Controller General of India (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.

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.

DRL, however, said that “Grastim and Neupogen are brand names of human recombinant granulocyte colony stimulating a belief that “they are chemically, physically and biologically comparable in properties and characteristics.”

Dr Reddy’s has also been asked to submit its modified PIs by the MRTPC. Dr Reddy’s had said that it has received an approval from the DCI for the PI of the company’s human recombinant granulocyte colony stimulating factor filgrastim injection (Grastim).

The company had submitted a modified product insert to the DCGI as per its recommendations on September 28, 2001 and the same was approved by DCGI, it said.