Sun Pharma gets CDSCO panel nod to additional pack size of Gemcitabine

New Delhi: Pharmaceutical major, Sun Pharma has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for the manufacturing and marketing of the chemotherapeutic agent, Gemcitabine Hydrochloride Injection (10mg/ml) for an additional pack size of 2200mg/220ml. 

This came in the wake of the proposal presented by the drug giant for an additional pack size for Gemcitabine Hydrochloride Injection (10mg/ml) – 2200mg/220ml.

Gemcitabine is a nucleoside analog and a chemotherapeutic agent. It was originally investigated for its antiviral effects, but it is now used as an anticancer therapy for various cancers.

Gemcitabine is a cytidine analog with two fluorine atoms replacing the hydroxyl in the ribose. As a prodrug, gemcitabine is transformed into its active metabolites that act by replacing the building blocks of nucleic acids during DNA elongation, arresting tumour growth and promoting apoptosis of malignant cells.

Gemcitabine is converted intracellularly to the active metabolites difluorodeoxycytidine di-and triphosphate (dFdCDP, dFdCTP). dFdCDP inhibits ribonucleotide reductase, thereby decreasing the deoxynucleotide pool available for DNA synthesis; dFdCTP is incorporated into DNA, resulting in DNA strand termination and apoptosis.

Gemcitabine is approved by the FDA for the treatment of advanced ovarian cancer in combination with carboplatin, metastatic breast cancer in combination with paclitaxel, non-small cell lung cancer in conjunction with cisplatin, and pancreatic cancer as monotherapy.

At the 111th SEC meeting for Oncology and Hematology held on 06.08.2021 and 10.08.2021, the committee extensively evaluated the proposal presented by the drug-maker Sun Pharma for an additional pack size for Gemcitabine Hydrochloride Injection (10mg/ml) – 2200mg/220ml.

In respect to the above mentioned chemotherapy drug, the committee noted that the proposed product is already approved in the USA and EU.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market Gemcitabine Hydrochloride Injection (10mg/ml) – 2200mg/220ml (Additional Pack size) for the already approved indication.