Hyderabad: A drug manufacturing unit involved in production of anti-cancer injections as well as antibiotics without following the prescribed norms — was busted by the officials of Drugs Control Administration (DCA) on Wednesday.
The production unit was found making anti-cancer drug cyclophosphamide injection illegally during the raid conducted on Indian Genomix Pvt. Ltd at Cherlapally.
The company was involved in manufacturing cytotoxic, anti-cancer drugs as well as antibiotic injections. Without following the good manufacturing practices (GMPs) guidelines, these two types of drugs were being made at the same facility posing a major risk of cross-contamination of medicines. The production unit was not following the norms and thereby posing a serious health risk, DCA DG V.B. Kamalasan Reddy stated in a press statement on Wednesday.
The cytotoxic anti-cancer drug ‘cyclophosphamide injection’ alters the genetic material (DNA and RNA) of the cells and hence checks the growth or replication of cancer cells. It is used in providing chemotherapy to cancer patients and can cause severe side-effects, Kamalasan Reddy added.
The cytotoxic anti-cancer drugs should be manufactured at a separate, dedicated and self-contained production facility and as per the good manufacturing practices (GMPs) guidelines, so as to ensure a clear-cut separation of cytotoxic substances from other general drugs; otherwise ‘cross-contamination’ of general drugs with ‘cytotoxic anti-cancer drugs’ might lead to serious health consequences in a patient who is not suffering from cancer, he said.
A dedicated facility for handling cytotoxic drugs is crucial and Indian Genomix Pvt. Ltd. located at IDA Cherlapally was not following the norms while producing the anti-cancer drug. The drug manufacturing unit did have the requisite license for making anti-cancer drugs. The company was involved in manufacturing antibiotic injections, together with anti-cancer drugs posing a serious medical hazard, said the DG.
During the raid, it was detected that cytotoxic anti-cancer drugs such as ‘cyclophosphamide injection’, which is used in chemotherapy for patients suffering from blood, breast and ovarian cancer as well as lymphoma. But, the Indian Genomix Pvt. Ltd was not authorised to manufacture anti-cancer drugs and did not have a separate and dedicated facility to manufacture cytotoxic anti-cancer drugs. The firm had a licence to manufacture antibiotic injections and other general drugs only,” the DG added.
DCA officials seized the stocks of anti-cancer drugs along with delivery challans and invoices during the raid and lifted the samples for analysis. Further investigation will be carried out and action will be taken as per the law against the offenders.
