Natco seeks CDSCO approval for Phase III trial of Molnupiravir for COVID-19 treatment

Natco Pharma said pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication.
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Drug major Natco Pharma on Monday said it has sought approval from the Central Drugs Standard Control Organisation (CDSCO) in India for the Phase III clinical trial of Molnupiravir capsules for the treatment of COVID-19 patients.

CDSCO is responsible for the approval of drugs, the conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country, and coordination of the activities of state drug control organisations.

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The drugmaker said pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication.

"Patients treated with Molnupiravir achieved response within five days of therapy, indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy, the company added.

Natco is hoping that CDSCO would give emergency approval of this drug based on compassionate use for patients.

Compassionate use approval is given for investigational drugs so a patient with an immediately life-threatening condition can gain access to the drug, it said, adding the company is ready to launch the product this month if approval is given.

Shares of Natco Pharma were trading 4.16 percent higher at Rs 914.35 apiece on the Bombay Stock Exchange (BSE).

In another development, Google CEO Sundar Pichai and his Microsoft counterpart Satya Nadella on Monday took to Twitter to assure their support to India as the country battles the second deadly wave of COVID-19. Both the Indian-American tech bosses grew up in India — Sundar in Chennai and Satya in Hyderabad.

“Devastated to see the worsening COVID-19 crisis in India,” Sundar Pichai tweeted, adding that Google and its employees are providing Rs 135 crore in funding to the UNICEF and Give India — an Indian non-profit organisation. The donation will go towards procuring medical supplies, supporting high-risk communities, and grants to help spread critical information about the deadly virus.

(Disclaimer: Additional background information has been added to this PTI copy for context)

Edited by Suman Singh

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