Dr Reddys Clears The Air Over Dcgi Order On Grastim

Dr Reddy`s Laboratories has clarified that the order from the Drug Controller General of India (DCGI) on its biotech product Grastim (generic name filgrastim) refers to recall of batches with the disputed package inserts and not the withdrawal of the drug itself from the market.

" This is not a product withdrawal," Dr Reddy's said in a release. The company was reacting to certain media reports with reference to a complaint filed by Nicholas Piramal to DGCI on Grastim.

Nicholas Piramal, which markets a rival brand in the same product segment, has raised certain objections on claims made by Dr Reddy's about Grastim in the product insert. Grastim is used in chemotherapy and in bone marrow transplantation.

 

"The clinical trial data of Grastim was presented to more than 200 oncologists in India. They have expressed satisfaction with the safety, efficacy and toxicity studies conducted by Dr Reddy`s. Oncologists have been using the product for two months now ", Dr Reddy's explained.

The company said it has been advised by the DCGI to make certain modifications to the package inserts, which the company has agreed to implement. The modified package insert has been submitted to the DCGI on September 28, 2001 for its approval, it added.

According to the company, the case with Grastim is with regard to the information contained in the package insert and not with any intellectual property violations.