In a significant crackdown, the Drugs Control Administration (DCA) officials exposed a drug manufacturing unit engaged in the illegal production of anti-cancer injections and antibiotics without adhering to prescribed norms. The raid conducted on Indian Genomix Pvt. Ltd. at Cherlapally revealed serious violations of good manufacturing practices (GMPs), posing substantial health risks.
Illegal Production of Anti-Cancer Drug: The manufacturing unit was illicitly producing the anti-cancer drug cyclophosphamide injection during the raid. The company, Indian Genomix Pvt. Ltd., was involved in the production of cytotoxic anti-cancer drugs and antibiotic injections without maintaining the necessary separation and precautions outlined in GMP guidelines.
Risk of Cross-Contamination: The violation of norms raised concerns about the risk of cross-contamination between cytotoxic anti-cancer drugs and general antibiotics, as both were being produced at the same facility. This oversight posed a severe health hazard, as the cytotoxic drug cyclophosphamide injection can lead to alterations in the genetic material of cells, impacting the growth or replication of cancer cells during chemotherapy.
Importance of Dedicated Facilities: Cytotoxic anti-cancer drugs, like cyclophosphamide injection, require manufacturing in dedicated, separate, and self-contained facilities to prevent cross-contamination and ensure patient safety. The Indian Genomix Pvt. Ltd. facility at IDA Cherlapally did not adhere to these critical norms, operating without the necessary infrastructure for handling cytotoxic drugs.
Violation of Licensing and Authorization: The drug manufacturing unit was found to lack authorization for the production of anti-cancer drugs, as it held a license solely for manufacturing antibiotic injections and other general drugs. Despite lacking the requisite authorization, the company was engaged in the illegal production of cytotoxic anti-cancer drugs.
Seizure of Stocks and Further Investigation: During the raid, DCA officials seized stocks of anti-cancer drugs, along with delivery challans and invoices. Samples were lifted for analysis, and further investigations will be conducted. The DG of DCA, V.B. Kamalasan Reddy, emphasized that appropriate legal actions would be taken against the offenders.
This crackdown underscores the importance of stringent adherence to pharmaceutical manufacturing guidelines to safeguard public health and maintain the integrity of drug production processes.
