DGCI asks Dr Reddy's to recall cancer drug

In an unprecedented move, the Drugs Controller General of India hasasked Dr Reddy's Laboratories to withdraw immediately from the market all batches of the company's recently-launched biotechnology cancer drug Grastim (recombinant granulocyte colony stimulating factor; filgrastim).

The DGCI's order says the package insert for Grastim "is not in accordance with our approval" given in June this year. The Economic Times quotes the order as saying that, to be in accordance with the approval granted to the company, it should re-submit the fresh package insert for the approval to the DGCI. "In the meanwhile, withdraw all the batches of the product with the existing package insert," the DGCI order says.

The newspaper, quoting drug industry sources, says the DGCI was unhappy that DRL apparently violated its approval by claiming in the package insert that the drug could be used for severe chronic congenital neutropenia, acute myeloid leukemia, peripheral blood progenitor cell mobilization and allogeneic bone marrow transplantation. Sources said the DGCI was not happy that the package insert also failed to caution use of the drug by patients suffering from kidney and liver problems.