Kerala RCC Blacklists Globela Pharma After Brain Cancer Drug Found in Wrong Packaging
New Delhi: In a serious lapse that could have endangered patient safety, the Regional Cancer Centre (RCC) in Thiruvananthapuram has 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 has led to the registration of a case under Section 17B of the Drugs and Cosmetics Act, which deals with offenses related to misbranded drugs.
This prompted rumors that patients had been given the wrong medicine, but the RCC quickly clarified that no patient had received the incorrect drug. 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.
As reported by The Week, under the Regional Cancer Centre’s 2024–25 purchase and tender process, Globela Pharma was contracted to supply Temozolomide in 250 mg, 100 mg, and 20 mg strengths. The packaging mix-up was traced to a batch of 92 packets of Temozolomide 100 mg (Batch No. GSC24056) that had been delivered to the RCC on March 25.
Commenting on the mix-up, Dr. R. Rejanish Kumar, Director of the RCC, stated, “Every time a batch of medicine is received, the batch number and documents are thoroughly verified before stock entry.”
The issue came to light on July 12, when pharmacy staff noticed that two packets in the batch were labelled “Etoposide 50 mg”. On opening them, they found bottles correctly labelled as Temozolomide. The incident prompted the immediate suspension of distribution and notification to the supplier.
Subsequently, the RCC Drug Committee, in its meeting on July 30, decided to alert the Kerala Drugs Controller and blacklist Globela Pharma from all future supplies and tenders related to cancer medicines.
However, the regulatory inspection was carried out only on October 6, when officials from the Drugs Controller’s office visited the RCC and seized the suspected stock. Drugs Controller Dr Sujith Kumar confirmed to THE WEEK that a case has been filed under Section 17B of the Drugs and Cosmetics Act, which deals with offenses related to misbranded drugs.
Questions have emerged over why the RCC reported the matter to regulators only in late September—over two months after discovering the packaging anomaly. The Drugs Controller has since filed a report before the Additional Chief Judicial Magistrate Court, Thiruvananthapuram, on October 8.
