New Delhi: Hyderabad-based Natco Pharma Ltd is preparing to relaunch a breast cancer drug that was recalled from the domestic market last year following a suspension order by India’s drugs regulator over toxicity issues. However, the drug will have to clear quality tests at government laboratories before it can re-enter the market.
Sold under the name Albupax, the drug is the only generic version of Abraxane, which is patented by US-based Abraxis BioScience Inc. and marketed by Bangalore-based Biocon Ltd in India. Industry estimates put the market for the drug at Rs200 crore in India.
“We are looking to relaunch the drug after the alleged failure of our drug in the government’s Kolkata-based Central Drug Laboratory (CDL). But we have yet to decide the timing of the launch,” said a Natco Pharma spokesperson.
Health secretary K. Sujatha Rao said the “(health) minister has said that we will conduct more tests and if found safe, Natco can relaunch the product”.
Last week, talking to Mint, the drugs controller general of India (DGCI) also agreed that if the drug was found safe after testing at government labs, it would be given marketing approval. He could not be contacted for further clarity at the time of going to press.
Natco’s version was launched in India in September 2008 after the clinical trial data was cleared by DGCI. In July 2009, however, the regulator ordered a recall as well as a suspension on further sales after tests showed it could damage the liver.
The Natco spokesperson said the firm strongly denies any quality problems with the drug, saying that all the testing methods for the clinical trials were known to DCGI.
“But during the testing of the drug at the government lab, proper test procedures were not followed,” he said.
The move by DCGI to test Albupax came after patent holder Abraxis filed a written complaint against Natco’s drug to DCGI, citing serious side effects that the generic medicine might cause.
Later, under the provisions of the Drugs and Cosmetics Act, Natco appealed to the Union health ministry. In a rare instance of DCGI being overruled, the health ministry in January stayed the regulator’s order suspending marketing of the drug.
In a statement at the time, Natco said that since Albupax is a nanotechnology-based drug, the testing methods used to evaluate it are highly complex and variable.
“In our appeal, among many other things, we primarily contended that proper test procedures and protocols were not followed,” the Natco spokesperson added.
DCGI had sent samples of Natco’s Albupax to CDL for testing endotoxin and chloroform levels. The samples failed the endotoxin test. Endotoxins, toxins associated with disease-causing bacteria, were found to be higher than the prescribed limit.
“Everyone has a right to appeal and when Natco appealed, the minister asked that their appeal be lodged and then stayed the DCGI’s order,” said health secretary Rao.
Natco said it has tied up with Dr Reddy’s Laboratories Ltd to take this product to the US market, where they are looking to challenge Abraxis’ patent.
Abraxis’ patent was rejected recently following pre-grant opposition filed by Natco. Abraxis then appealed to the Delhi high court, which directed it to approach the Intellectual Property Appelate Board.