Nicholas Piramal asks DCI to order withdrawal of Grastim stocks

Anju Ghangurde

Mumbai, Sept 20: Nicholas Piramal (NP) has written to the Drugs Controller General of India (DCI), Mr Ashwini Kumar, urging him to order the withdrawal of stocks of Dr Reddy’s Labs Grastim (filgrastim) in the market. NP alleges that the package insert (PI) of Grastim contains “several false and misleading statements” to give an impression that Grastim was approved by the FDA for three indications in February 1991 and for a fourth indication on December 28, 1995.

Ironically, Grastim was approved by the Indian Food and Drug Administration only in 2001, and NP adds that the approvals in 1991 and 1995 were given by the US FDA for Neupogen (filgrastim), which is imported from Swiss giant F Hoffmann La Roche and marketed by NP in India. Filgrastim was approved for marketing in the US in 1991 and over the last 10 years has been used by over 2.7 million patients worldwide.

“Dr Reddy’s Labs has merely adopted data, which is available for Neupogen from Amgen and by juxtapositioning the trademark Grastim with the word Filgrastim or the word G-CSF, has attempted to create an impression that the claims made by Neupogen are equally applicable to Grastim. In case these claims are found to be untrue, the patient’s life would be compromised,” NP has alleged.

Moreover, at various places in the PI, Dr Reddy’s has allegedly made efforts to “create an impression with doctors, that Grastim has the same properties as Neupogen, can be used in the same indications, is safe to use in children ...”. NP says that some of the claims are based on trials in children.

Dr Reddy’s executive vice-president (emerging businesses) Dr Jayaram Chigurupati, refutes these charges and said, “DRL has never claimed that Grastim was approved by the US FDA and the doctors are well acquainted with this fact. To be exact, the product description in the product insert reads “The FDA approved the drug in February 1991.” The insert further states “A fourth indication, mobilisation of PBPC was approved in December 1995.”

It is obvious that this means filgrastim and not Grastim. The clinical trial data was presented to more than 200 oncologists. They were very satisfied with the safety, efficacy and toxicity studies conducted by DRL. Oncologists have been using the product for two months.

Based on their experience, we strongly believe that Grastim will stand the test of time “. He further adds that DRL has established in invivo and invitro studies that Grastim and Roche’s Neupogen are biologically and physiologically similar. “DRL has included this information in the marketing literature for Grastim. We are vigorously contesting the charges by Nicholas Piramal”.

NP, however, says Dr Reddy’s alleged misdeclarations are further compounded when it has apparently cited references in its package insert (PI). NP says that Dr Reddy’s Reference 3 “Dale DC, Bonilla MA, Davis MV et al. A randomised controlled phase-III trial of recombinant human granulocyte colony-stimulating factor (Grastim) for treatment of severe chronic neutropenia. Blood 1993, 81-2496501,” could lead doctors to believe that Dr Reddy’s products was referred to in the said Article as early as in 1993.

“The false statements are made with a view to making the medical fraternity believe that Grastim (not the molecule filgrastim (G-CSF)) not only contains indigenously manufactured filgrastim G-CSF, but is backed by documented studies to substantiate its claims on safety, efficacy ...”. NP says the DCI must prohibit Dr Reddy’s from using the PI and brochure and issue a letter, to the concerned medical fraternity explaining the true facts.

Meanwhile, Nicholas Piramal has moved the Monopolies & Restrictive Trade Practices Commission urging it to ask DRL to withdraw Grastim stocks and stop sales of the product, till the claims are proved. Sources say that the counsel for DRL has sought an adjournment to obtain instructions with “regard to deleting portions as referred to as above and file the reply”.