Hyderabad: On credible information, Drugs Control Administration, Telangana officials raided Indian Genomix Pvt. Ltd., located at Phase-II, IDA Cherlapally, Medchal-Malkajgiri District, on Tuesday and Wednesday, and detected illegal manufacturing of a cytotoxic anti-cancer drug ‘Cyclophosphamide Injection’.
Cyclophosphamide is a cancer ‘chemotherapy’ drug used to treat various types of cancers viz. blood cancer, breast cancer, ovarian cancer, lymphoma etc.
Indian Genomix Pvt. Ltd. does not hold the licence to manufacture ‘anti-cancer drugs’ at its facility and also does not have a separate, dedicated facility to manufacture cytotoxic anti-cancer drugs, DCA stated.
The firm holds licences only to manufacture antibiotic injections and other general drugs.
Cytotoxic Anti-cancer drugs cannot be manufactured together with general drugs.
Dedicated facilities are mandatory for handling cytotoxic drugs. Cytotoxic drugs destroy living cells and shall be manufactured in “separate dedicated and self-contained production facilities”, as per Good Manufacturing Practices (GMPs) of Drugs and Cosmetics Act, 1940, as cross-contamination of general medicines with cytotoxic anticancer drugs leads to serious health issues in patients.
Patients who take ‘antibiotic injections’ contaminated with cytotoxic anti-cancer drugs may experience serious side effects such as blood in urine, bone marrow suppression, heart damage, anemia, decrease of White Blood Cell (WBC) counts leading to infections due to suppression of immune system, oral mucositis, hair loss, bleeding, bruising, vomiting, diarrhea, nausea, infertility etc., due to destruction of normal and healthy cells.
During the raid, DCA officials detected the manufacturing of a cytotoxic anticancer drug ‘Cyclophosphamide Injection’, without a drug licence, together with antibiotic injections, contravening the provisions of Good Manufacturing Practices (GMP), thus placing the patient’s health at grave risk.
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, K-66, Tarapur- MIDC, Boisar, District-Palghar, Maharashtra.
During the raid, the director of the company Indian Genomix Private Limited. Anil Kumar revealed that the said anticancer AP canisters were procured from SP Accure Labs Pvt. Ltd. (SPAL Private Limited), located at Plot No. 20, Biotech Park, Phase-II, Lalgadi-Malakpet, Shameerpet.
According to DCA, the director of the company M. Anil Kumar, revealed that they utilized the anticancer drug Cyclophosphamide API, received from SP Accure Labs Pvt. Ltd., to manufacture the formulation ‘Cyclophosphamide Injection’ in their antibiotic injectable facility and sold the formulation again to SP Accure Labs.
M. Anil Kumar submitted delivery challans and invoices regarding the transactions with SP Accure Labs regarding the said anti-cancer drug.
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, said DCA officials
