According to TSDCA, Indian Genomic Pvt Ltd was manufacturing cytotoxic anti-cancer drugs together with antibiotic injections, thereby posing a serious risk to public health.
Updated On – 7 February 2024, 03:46 PM
Hyderabad: In a major achievement in curtailing illegal manufacturing of anti-cancer drugs, the TS Drugs Control Administration (TSDCA) has busted a pharma company Indian Genomic Pvt Ltd in Cherlapally while illegally manufacturing an anti-cancer drug ‘Cyclophosphamide Injection’ without any legal licensing and permissions, thus putting the lives of cancer patients at risk.
According to TSDCA, Indian Genomic Pvt Ltd was manufacturing cytotoxic anti-cancer drugs together with antibiotic injections, thereby posing a serious risk to public health. Cytotoxic anti-cancer drug ‘Cyclophosphamide Injection’ is used for chemotherapy in cancer patients due to their ability to damage the genetic material (DNA and RNA) of the cells thereby stopping growth and multiplication of cancer cells.
Such drugs are known for causing severe side effects and that’s the reason why they must be manufactured in separate dedicated and self-contained production facilities, as per Good Manufacturing Practices (GMPs) guidelines.
This will ensure a clear-cut separation of these cytotoxic substances from other general drugs; as ‘cross-contamination’ of general drugs with ‘cytotoxic anti-cancer drugs’, if manufactured in the same facility, leads to serious health consequences in the patients, Director General of TSDCA, V B Kamalsan Reddy on Wednesday said.
The DCA team raided the premises of Indian Gemoix Pvt Ltd on Tuesday and Wednesday and seized the stocks of the chemotherapy drug. The pharma company does not hold license to manufacture the anti-cancer drug at its manufacturing facility and also does not have separate, dedicated facility to manufacture cytotoxic anti-cancer drugs. The firm holds licenses only to manufacture antibiotic injections and other general drugs.
The DCA officials detected three Aluminium canisters of anticancer drug Cyclophosphamide API (Active Pharmaceutical Ingredient) in the production area of the antibiotic injectable facility. The said API canisters were labelled as manufactured by BO-Chem Private Limited, Boisar, Palghar, Maharashtra.
During the raid, the Director, Indian Genomix Pvt. Ltd, M. Anil Kumar revealed that the said anticancer API canisters was procured from SP Accure Labs Pvt. Ltd. (SPAL Private Limited), Lalgadi-Malakpet, Shameerpet.
According to Anil Kumar, the company utilized the anticancer drug Cyclophosphamide API to manufacture the formulation ‘Cyclophosphamide Injection’ in their antibiotic injectable facility and sold the formulation again to SP Accure Labs Pvt. Ltd. (SPAL Private Limited). The company official submitted delivery challans and invoices regarding the transactions with SP Accure Labs Pvt. Ltd. regarding the said anti-cancer drug.
On their part, the DCA officials seized the stocks of anti-cancer drug Cyclophosphamide along with delivery challans and invoices during the raid and lifted the samples for analysis. Further investigation shall be carried out and action shall be taken as per the law against all the offenders.
