The Drug Controller General of India recently ordered recall of Hyderabad based Natco Pharma’s generic drug Albupax used for treatment of Breast Cancer, after written complaints from the US company Abraxis BioScience, that manufactures the original drug. The complaints alleged that tests displayed that Albupax may cause liver damage. The drug is based on nanotechnology and had satisfactorily passed the clinical trial tests, it is reported. However, the DCGI ordered fresh tests, according to news reports.

The Central Drug Laboratory situated in Kolkata performed endotoxin and chloroform level checks on the drug and found that the levels of endotoxin exceeded beyond the prescribed limits. With the proliferation of cancer in India and continuous surge in reported cases of breast cancer, any goof ups in the medication may prove to be disastrous for the already small percentage of patients who are able to afford treatment. Other treatments for the ailment include surgery, radiotherapy and chemotherapy.

The original drug costs Rs. 5000 more than the generic version and is distributed through Biocon. “Abraxis had collected samples of Albupax and got them tested in several labs in the US. Its complaint to the Indian regulator was based on those studies of the collected samples,” a government official was reported saying. Natco Pharma has been asked to stop production, distribution and marketing of the drug until the conclusion of investigations, though the pharma company asserted that the testing procedures for nanotechnology based drugs are complex. It had introduced the product in India in September last year and has tied up with Dr Reddy’s Laboratories to take this product to the US.

It is notable that GSK has also filed for a patent for breast cancer drug at the Indian Patent Office. GSK’s oldest patent application, for Tykerb, is pending with the Kolkata patent office since 1997. Two more patent applications by the company for Lapatinib species and salt are also pending approval. Tykerb was approved in the US in March last year. This breast cancer drug is expected to earn the company $890 million (about Rs 3,500 crore) globally by 2010.