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The Drug Controller General of India (DCGI) has directed drug regulators in all states and union territories to withdraw AstraZeneca’s cancer drug tablets for the treatment of patients who are scheduled to receive chemotherapy three or more times. State regulators asked the manufacturers to stop marketing the drug to treat patients with gBRCA mutations and ovarian and breast cancer because of the potential for adverse effects.
The top drug regulator said the drug could continue to be marketed for other approved indications. DCGI sent a letter to the regulators on May 16. AstraZeneca Pharma India Limited is said to have sent them a request to withdraw the indications for Olaparib 100 mg and 150 mg tablets in the treatment of patients with GBRCA mutation and ovarian cancer that has been treated three or more times previously treated with chemotherapy.
The letter said the matter was reviewed in consultation with SEC (Oncology) experts at a meeting held on March 19 and 20, 2024 at CDCSO. The company presented clinical evidence to cancel the indication for Olaparib tablets. In light of these circumstances, you are requested to order all drug manufacturers in your area to stop marketing Olaparib tablets (100 mg and 150 mg). The drug may continue to be marketed for other approved indications.
