According to a recent media report in The Hindu, the directive came from Commission Chairperson and former judge Alexander Thomas in a case the panel registered on its own motion based on media reports. The commission had earlier called for a detailed inquiry into the incident.
As per the report submitted by the RCC Director, the error came to light on July 9 last year when pharmacy staff, while dispensing medicines, detected a mismatch in labeling. In a batch of ten packs marked as Temozolomide 100 mg, two packets were found to carry labels for Etoposide 50 mg. Essentially, a drug intended for one condition had been placed inside packaging meant for another, raising serious concerns about patient safety and quality control.
After the error was detected, the State Drugs Controller confiscated five packs of the medicines and submitted them before the court. The Drugs Controller, who appeared before the commission, stated that legal action has been launched against the supplier, and the company has also been placed on a blacklist.
Earlier, the Medical Dialogues Team had reported that the Regional Cancer Centre (RCC) in Thiruvananthapuram had barred Globela Pharma from future dealings after uncovering that Temozolomide, a brain cancer drug, had been supplied in packaging labelled for Etoposide, which is used to treat lung cancer.
The incident led to the registration of a case under Section 17B of the Drugs and Cosmetics Act, which deals with offenses related to misbranded drugs. Officials explained that the error was identified during internal verification prior to distribution, after which the entire batch was promptly quarantined.
Temozolomide is an alkylating agent used to treat glioblastoma multiforme and refractory anaplastic astrocytoma. Refractory anaplastic astrocytoma (WHO grade III) and Glioblastoma multiforme (WHO grade IV) are primary malignant brain tumors with poor prognosis and limited treatment options.
Etoposide is a podophyllotoxin derivative used to treat testicular and small cell lung tumors. Etoposide inhibits DNA topoisomerase II, thereby inhibiting DNA re-ligation. This causes critical errors in DNA synthesis at the premitotic stage of cell division and can lead to apoptosis of the cancer cell. Etoposide is cell cycle dependent and phase specific, affecting mainly the S and G2 phases of cell division. Inhibition of the topoisomerase II alpha isoform results in the anti-tumor activity of etoposide. The drug is also capable of inhibiting the beta isoform, but inhibition of this target is not associated with the anti-tumor activity. It is instead associated with the carcinogenic effect.
Considering the above, the SHRC chairperson directed the RCC Director to make sure that legal proceedings against the company are carried forward and finalized without delay, highlighting the seriousness of the lapse and the importance of accountability in the supply of essential medicines, The Hindu reported.
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