AstraZeneca conducts nearly 50 trials to import critical drugs to India

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AstraZeneca Pharma plans to import a range of critical medicines and is currently conducting about 50 clinical trials in India.


AstraZeneca intends to import Palivizumab for respiratory infections, Tremelimumab for cancer, and a fixed-dose combination of Budesonide, Formoterol Fumarate, and Glycopyrronium for asthma. These plans depend on receiving all necessary statutory regulatory permissions, the company stated.


Last week, AstraZeneca’s new antidote, Andexanet Alfa (for bleeding complications), received import permission from the Central Drugs Standard Control Organisation (CDSCO). The company has stated that the pricing of Andexanet Alfa will be influenced by a commitment to fostering a sustainable and equitable healthcare environment.


Andexanet Alfa, designed as an antidote, specifically reverses the effects of anticoagulant medications in emergencies, allowing prompt resumption of anticoagulation after a bleeding event. The therapy involves intravenous (IV) administration through a bolus lasting 15 to 30 minutes, followed by a two-hour infusion.


With over 50 ongoing global clinical trials in India across various 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. In India, this ensures alignment with the country’s healthcare needs, driving our commitment to advancing medical science and addressing specific challenges.”


AstraZeneca’s import strategies aim to align with India’s regulatory landscape, prioritising timely access to medicines for patients across the nation.

First Published: Jan 28 2024 | 1:54 PM IST