Hyderabad: illegal anti-cancer drug manufacturing facility busted in Hyderabad
Telangana Drugs Control Administration (DCA) officials busted illegal manufacturing of an anti-cancer drug ‘Cyclophosphamide Injection’ at Indian Genomix Pvt. Ltd. located at Cherlapally in the city on Wednesday.
Hyderabad: Telangana Drugs Control Administration (DCA) officials busted illegal manufacturing of an anti-cancer drug ‘Cyclophosphamide Injection’ at Indian Genomix Pvt. Ltd. located at Cherlapally in the city on Wednesday.
On credible information, DCA officials raided Indian Genomix Pvt. Ltd., located at IDA Cherlapally (Medchal-Malkajgiri District), for two days from Tuesday and detected illegal manufacturing of the cytotoxic anti-cancer drug ‘Cyclophosphamide Injection’, DCA Director General VB Kamalasan Reddy said in a release here.
Cyclophosphamide is a cancer ‘chemotherapy’ drug used to treat various types of cancer: blood cancer, breast cancer, ovarian cancer, and lymphoma.
The company illegally manufactured the anti-cancer drug without a drug licence in an antibiotic injection manufacturing line, which poses a serious medical hazard, and seized the stocks during the raid, the release said.
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.
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, anaemia, a decrease in white blood cell (WBC) counts leading to infections due to suppression of the immune system, oral mucositis, hair loss, bleeding, bruising, vomiting, diarrhoea, nausea, and infertility due to the destruction of normal and healthy cells.
DCA officials detected three aluminium canisters of the 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 Pvt. Ltd., M. Anil Kumar, revealed that the said anticancer API canisters were procured from SP Accure Labs Pvt. Ltd. (SPAL Private Limited), located at Plot No. 20, Biotech Park, Phase-II, Lalgadi-Malakpet, Shameerpet.
M. Anil Kumar, director of the company, also revealed that they utilised 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 Pvt. Ltd. (SPAL Private Limited), located at Plot No. 20, Biotech Park, Phase-II, Lalgadi-Malakpet, Shameerpet. M. Anil Kumar submitted delivery challans and invoices regarding the transactions with SP Accure Labs Pvt. Ltd. regarding the said anti-cancer drug.
DCA officials seized the stocks of the anti-cancer drug Cyclophosphamide along with delivery challans and invoices during the raid and lifted the samples for analysis during the raid.
Further investigation will be carried out, and action will be taken as per the law against all the offenders.
Assistant Director M. Vijay Gopal, Assistant Director P. Ramu, and Drugs Inspectors T. Shiva Teja, M. Varaprasad, and Ch. Karthik Siva Chaitanya, E. Thirupathi, and A. Rashmi are among the DCA officers who carried out the raid.
