Aurobindo Pharma, MSN Labs seek DCGI nod for Phase-III trials of Molnupiravir

The SEC opined that the firms should submit the same in writing to CDSCO for further consideration.

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DCGI CDSCO

Last Updated on October 11, 2021 by The Health Master

Two Indian pharmaceutical companies have sought permission from India’s drug regulator to continue phase III trials on antiviral drug molnupiravir in mild C-19 patient. US firm Merck & Co’s experimental antiviral drug molnupiravir is touted to become first antiviral drug to treat C-19.

Last week, Aurobindo Pharma and MSN Laboratories presented the interim clinical trial data in moderate patients before the the Subject subject expert committee (SEC) — the expert panel under the Drug Controller General of India (DCGI).

The SEC advises the drug regulator on applications seeking approvals for new vaccines, drugs and clinical trials in India.

In a meeting held on October 4, both the companies said that they “they want to discontinue phase III trial in moderate C-19 patients and continue the phase III trial in mild C-19 patients”, as per the minutes of the meeting. ET has seen the minutes of the SEC meeting.

The SEC opined that the firms should submit the same in writing to CDSCO for further consideration.

According to Merck Molnupiravir reduces the risk of hospitalisation and death by 50% in an interim trial. The company also said that they would seek emergency approval from the US regulator.

Merck has also entered into voluntary licensing agreements with at many Indian drug companies including Dr Reddy’s Laboratories, Cipla, Sun Pharma, Emcure Pharmaceuticals, Aurobindo Pharma, among others.

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