Natco Pharma denies legal action from DCGI for marketing ’sub-standard’ breast cancer drug Albupax

Reports of DCGI’s criminal proceedings is a malicious campaign by rival firm, alleges Natco

Natco Pharma has denied any legal action iniated against the company from the Drug Controller General of India (DCGI) for marketing an breast cancer drug Albupax which is allegedly tested to be containing high levels of dangerous endotoxins.

Natco Pharma recalled Albupax from the market as DCGI had asked Natco to withdraw the drug within two weeks, after tests showed the endotoxins in the drug could cause damage to the liver.

India’s top drug regulator DCGI was planning to take criminal proceedings against Hyderabad-based Natco Pharma for selling “substandard” breast cancer drug Albupax and seek prison terms for senior executives of the company, reports alleged quoting officials with the Central Drugs Standard Control Organisation (CDSCO).

CDSCO, the DCGI’s office, monitors drug quality and gives marketing approval for medicines.

DCGI could approach a court and request prosecution against Natco Pharma for marketing the harmful breast cancer drug Albupax under the offences and penalties clause of the Drugs and Cosmetics Act, reports has said.

Violations of  the offences and penalties clause may invite a prison term of up to three years along with penalties for some of the top executives of Natco.

DCGI might also consider other options like cancelling marketing approval for the drug and asking state authorities to suspend the company’s manufacturing licence for some time.

Dr Surinder Singh,DCGI, also confirmed in a report that his office was seeking legal opinion and would soon initiate appropriate action because Albupax’ was a case of selling substandard drug as the data submitted for marketing approval showed that the drug had successfully passed all tests.

Natco Pharma’s Albupax is a nanotechnology-based generic version of Abraxane marketed by the US company Abraxis BioScience.

Natco launched Albupax in Indian market in September 2008 at a price which nearly Rs 5000 less per vial than the retail selling price of Abraxis Abraxane which is marketed in India by the Bangalore-based Biocon Ltd.

Abraxis, in complaint letter to DCGI filed in early 2009 pointed out that Natco’s Albupax can lead to serious side-effects.

Following Abraxis complaint DCGI ordered a fresh round of laboratory anlysis for Albupax.

Examination of Albupax samples at the Kolkata-based Central Drug Laboratory (CDL) found that the breat cancer nanotech drug had high levels of endotoxins and chloroform.

DCGI immediately ordered recall of Albupax from the market, based on the CDL test report.

However, Natco Pharma, which recalled the drug following the DCGI directive, said test results on endotoxin levels are highly dependent on the test kit employed due to interference caused by the nano particulates and excipient proteins.

The kit by M/S Charles River is employed by the Govt. analyst CDL, Kolkata and the results obtained by this kit are known to vary by as much as 2-to-four fold according to manufacturer’s own manual, Natco explained in a press note.

The samples when analysed by a different kit (viz., the Lonza’s kit) yield different results all within the specified limits for endotoxins. These results are further confirmed by the National Accreditation Board for testing and calibration for Laboratories (NABL) accredited laboratory. Natco  obtained product license for Albupax  using the Lonza’s kit.

Natco has realized these test kit dependent results and is in the process of streamlining the test procedures to achieve foolproof results as a proactive measure.

A complex topic like nano technology and the test methods are being debated in the press without providing any technical background and details.

Natco is planning to submit an official complaint to the DCGI on this “insidious campaign through selective leaks and half-truths in the newspapers” with malafide mottive to denigrate the company’s image and reputation by a competitor company attempting to keep off the generic competition is completely blocked.adopted by our competition company, the note stated.

Apart from Natco Pharma, Fresenius Kabi Oncology, (formerly Dabur Pharma) is another firm which launched a generic version of Abraxane. Dabur Pharma launched the drug in the brand name Nanoxel in India in January 2007.

What is Abraxane?

Abraxane injectable suspension which contains paclitaxel protein-bound particles for injectable suspension (albumin bound), is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

Abraxane is a formulation of paclitaxel with a mean particle size of approximately 130 nanometers, that uses the natural properties of a human protein, albumin, to deliver the drug more effectively to tumors. By wrapping the albumin around the active drug. Abraxane can be administered to patients at higher doses, resulting in higher concentrations of the drug at the tumor site and higher efficacy compared to solvent-based paclitaxel.

Clinical trials have demonstrated that the tumor response rate was nearly double for patients who received Abraxane compared to those who received solvent-based paclitaxel.

US Food and Drug Administration approved Abraxane in 2005 and the European Medicines Agency (EMEA) approved Abraxane in 2008.

Abraxane is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, melanoma, pancreatic and ovarian.