 "AstraZeneca")
Drugmaker AstraZeneca plans to import a range of critical drugs and is currently conducting 50 clinical trials in India.
The pharma company is aiming to import Palivizumab for respiratory infections, Tremelimumab for cancer, and a Fixed Dose Combination (FDC) of Budesonide, Formoterol fumarate, Glycopyrronium for asthma combination. However, these plans depend on receiving all necessary statutory regulatory permissions, the company said.
Last week, AstraZeneca’s new antidote, Andexanet alfa (for bleeding complications) received permission to import from the Central Drugs Standard Control Organisation (CDSCO). The company has said the pricing of Andexanet alfa will be guided by a commitment to foster a ‘sustainable and equitable healthcare environment’.
Andexanet alfa, an antidote is specifically designed to reverse the effects of anticoagulant medications during emergency situations. It enables the prompt resumption of anticoagulation after a bleeding event. The therapy involves intravenous (IV) administration through a bolus lasting 15–30 minutes, followed by a 2-hour infusion.
With over fifty ongoing global clinical trials in India across different therapeutic areas, AstraZeneca said, “Our multicentric approach aligns with regulatory requirements, emphasising the importance of local clinical trial-based efficacy data for approvals. Our feasibility assessments meticulously consider operational, medical, and commercial perspectives to select appropriate countries. This approach ensures alignment with the country’s healthcare needs, driving our commitment to advancing medical science and addressing specific challenges”.
AstraZeneca’s import strategies are designed to align with India’s regulatory landscape and prioritise timely access to medicines for patients across the nation.
