On tuesday and Wednesday, telangana drugs Control Administration officers searched indian Genomix Pvt. Ltd., located at Phase-II, IDA Cherlapally, Medchal-Malkajgiri District, and discovered unlawful production of a cytotoxic anti-cancer medicine 'Cyclophosphamide Injection'.

Cyclophosphamide is a 'chemotherapy' medicine used to treat a variety of malignancies, including blood cancer, breast cancer, ovarian cancer, and lymphoma. indian Genomix Pvt. Ltd. does not have a licence to produce 'anti-cancer therapies' at its plant, nor does it have a separate, dedicated facility to manufacture cytotoxic anti-cancer drugs, according to the DCA.

The company only has permits to manufacture antibiotic injections and other generic medications. Cytotoxic anti-cancer medications cannot be synthesized alongside general pharmaceuticals. Dedicated facilities are required for handling cytotoxic medications. Cytotoxic drugs destroy living cells and must be manufactured in "separate dedicated and self-contained production facilities" under the drugs and Cosmetics Act of 1940, as cross-contamination of general medicines with cytotoxic anticancer drugs causes serious health problems in patients.

Patients who receive 'antibiotic injections' contaminated with cytotoxic anti-cancer drugs may experience serious side effects such as blood in their urine, bone marrow suppression, heart damage, anaemia, a decrease in White Blood Cell (WBC) counts leading to infections due to immune system suppression, oral mucositis, hair loss, bleeding, bruising, vomiting, diarrhoea, nausea, infertility, and so on, as a result of the destruction of normal and healthy cells.

During the raid, DCA authorities discovered the production of a deadly anticancer medicine 'Cyclophosphamide Injection' without a drug licence, as well as antibiotic injections, in violation of Good production Practices (GMP), putting the patient's health at danger.

DCA authorities discovered three aluminium canisters containing the anticancer medication Cyclophosphamide API (Active Pharmaceutical Ingredient) in the antibiotic injectable facility's manufacturing area. The API canisters were marked as being made by BO-Chem Private Limited, K-66, Tarapur-MIDC, Boisar, District-Palghar, Maharashtra.

During the operation, Anil Kumar, the director of indian Genomix Private Limited, stated that the anticancer ap canisters were obtained from SP Accure Labs Pvt. Ltd. (SPAL Private Limited), situated at Plot No. 20, Biotech Park, Phase-II, Lalgadi-Malakpet, Shameerpet.

According to DCA, the company's director, M. Anil Kumar, revealed that they used the anticancer drug Cyclophosphamide API obtained from SP Accure Labs Pvt. Ltd. to manufacture the formulation 'Cyclophosphamide Injection' in their antibiotic injectable facility and then sold the formulation to SP Accure Labs.

M. Anil Kumar presented delivery challans and invoices for transactions with SP Accure Labs involving the aforementioned anti-cancer medicine.

During the operation, DCA authorities confiscated stockpiles of the anti-cancer medicine Cyclophosphamide, as well as shipping challans and invoices, and samples were taken for examination. Further investigation will be conducted, and action will be taken in accordance with the law, DCA officials stated.
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Telangana Hyderabad

SIBY JEYYA

08/02/2024 09:09 AM