Cipla, Glenmark recall drugs in US due to manufacturing issues
Drug makers Cipla and Glenmark are recalling their products from the US market due to manufacturing issues.
This is in addition to the donations being offered by Lilly to the Indian government that will potentially help alleviate the burden of COVID-19, Visini said.
Drug firm Eli Lilly and Company on Monday said it has inked voluntary licensing agreements with Indian drug firms Sun Pharma, Cipla and Lupin to expedite availability of its arthritis drug Baricitinib for treatment of COVID-19 patients in India.
The company “has issued royalty-free, non-exclusive voluntary licenses to established Indian pharmaceutical manufacturers of generic medicines, Cipla, Lupin and Sun Pharmaceutical Industries, who are collaborating with Lilly to accelerate and expand the availability of Baricitinib in India,” Eli Lilly and Company said in a statement.
The company is also in discussions with several other Indian manufacturers for the potential grant of additional voluntary licenses, it added.
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“These voluntary licensing agreements will ensure high quality manufacturing and accessibility of Baricitinib during this pandemic improving the local treatment options available to positively impact the lives of people who are currently battling COVID-19 in India,” Eli Lilly and Company said.
The company has recently received permission for restricted emergency use by the Central Drugs Standard Control Organization (CDSCO), for Baricitinib to be used in combination with Remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalised adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation, it added.
During the pandemic, “we have responded by issuing three voluntary licenses for Baricitinib by pharmaceutical companies in India to accelerate its local manufacturing and distribution under best quality conditions. More licenses to additional Indian generic manufacturers are expected to be announced soon,” Luca Visini, Managing Director, India Subcontinent, Lilly India said.
This is in addition to the donations being offered by Lilly to the Indian government that will potentially help alleviate the burden of COVID-19, Visini said.
The company had last week said that an initial donation of 4,00,000 Baricitinib tablets through the humanitarian aid organisation, Direct Relief, is being made immediately available to the Indian government for eligible hospitalised COVID-19 patients in India and that it will work urgently to increase the quantity of donated product multifold over the coming weeks.
Baricitinib is currently registered in India for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.
Meanwhile, Eli Lilly and Company continues to engage in active dialogue with the regulatory authorities and government in India to donate its anti-COVID-19 treatments, including neutralising antibodies, the statement said.
On the development, Cipla MD and Global CEO Umang Vohra said, “Through the pandemic, Cipla has been at the forefront of COVID care and our partnership with Lilly is a demonstration of our unwavering commitment to care towards patients impacted by COVID-19.
In a similar vein, Sun Pharma, India business CEO Kirti Ganorkar said, Through this collaboration, we aim to join our forces with Lilly to accelerate access to Baricitinib in India at a time when it is most needed”.
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