Albupax, a drug used in the treatment of breast cancer, has been declared as sub-standard by the Government due to the presence of certain particles beyond the acceptable limits.
The Central Drug Laboratory, Kolkata, in its test report has declared the drug “to be not of standard quality” due to the presence of higher level of Endotoxin than acceptable limits, Health Ministry sources said.
Albupax is the first generic version of the international brand - Abraxane of Abraxis BioSciences, USA.
It has been indigenously developed by a company in India and is the first albumin bound Paclitaxel in nanoparticle to be developed in the country.
On the basis of the test reports, the Central Drugs Standard Control Organisation (CDSCO) in its letter dated October last year suspended permission to manufacture the said drug and also asked the manufacturer to recall the product from the market, the sources said.
The first permission to manufacture a new drug is given by the CDSCO on the basis of the certificate of analysis, test report, safety and efficacy data of the drug provided by the manufacturer as per the requirement of Drugs and Cosmetics Act and Rules.
During manufacturing, the firm is also required to comply with the conditions of permission and manufacturing Licence issued by the State Drug Controller relating to requirements of Good Manufacturing Practices (GMP) and Products specifications.
The manufacturer of the drug Albupax had provided certificate of analysis wherein all the parameters, including Endotoxin were within acceptable limits.
Accordingly, the permission to manufacture the drug was granted.
The Government has stayed the operation of the suspension order dated October 10 of the CDSCO with effect from December 2009 pending a decision on the appeal filed by the manufacturer.
Each 100 mg vial of Albupax is priced at Rs 11,500.
The estimated Indian market for this product is in the region of Rs 150 crore.