Generic drugs

Drug covid: India will become a hub for generic antiviral drugs Covid-19: Fitch

India will become the world’s largest general production center of Covid-19 antiviral drugs after the drug controller granted emergency use authorization to several pharmaceutical companies in the country to manufacture and market generic versions of molnupiravir, Fitch Solutions said Friday.

Increased access to molnupiravir will keep hospitalizations and deaths in India manageable as Omicron infections increase, Fitch Solutions said in a report.

Those who have obtained authorization from the Drugs Controller General of India (DCGI) include Dr. Reddy’s, Torrent Pharmaceuticals, Cipla, Sun Pharma, Natco Pharma, Viatris, Hetero Drugs and Mankind Pharma laboratories.

Lagevrio (Molnupiravir) was developed by Merck and Ridgeback Biotherapeutics, and it is the first-ever oral antiviral drug for the treatment of high-risk adults with mild to moderate Covid-19.

Following the clearance, Cipla, Sun Pharma and Dr Reddy’s labs are expected to launch molnupiravir capsules in the coming weeks, with the other companies to follow.

“This will make India the world’s largest production center for generic Covid-19 antiviral drugs,” he said. “The efficacy of molnupiravir during its phase III MOVe-OUT trial has been broadly promising, with a 50% reduction in hospitalizations and deaths in early-stage infections.” However, safety concerns remain about its risk of inducing harmful mutagenesis if the drug is prescribed globally, creating potential for new strains of Covid-19.

The second wave of Covid-19 in India peaked in April and May 2021, when the daily average of cases exceeded 4 lakh. The number of cases has declined significantly since then, with the national tally remaining below 10,000 cases per day for the rest of the year.

However, in recent days there has been an increase in daily cases of Covid-19 driven by the Omicron variant which is expected to overtake Delta as the dominant variant.

On January 6, 2022, Covid-19 cases rose to 1,17,100, of which 3,007 were confirmed to be the Omicron variant, according to the Union Ministry of Health.

“Additionally, India continues to lag behind in its Covid-19 vaccine deployment target, as 44.5% of the population has been fully vaccinated,” Fitch Solutions said citing Our World In Data. “Therefore, given the slow pace of vaccination and the recent sharp increase in Covid-19 cases, generic versions of molnupiravir could significantly reduce the risk of hospitalization or death. ”

Generic molnupiravir will increase access in India and other low and middle income countries (LMICs), while simplifying current supply chain barriers, he said.

A full five-day treatment with molnupiravir in the US costs around $ 712 (around Rs. 52,909). Generic versions of the drug will cost between $ 18.79 (around Rs 1,400) and $ 21.48 (around Rs 1,600). ) for a five-day course, which is significantly lower, according to Fitch Solutions.

For example, Dr Reddy priced his generic version of molnupiravir, molflu, at $ 0.4693 (Rs 35) per capsule and $ 18.79 (Rs 1,400) for a five-day course of 40 capsules. .

“With this relatively low cost, we expect generic versions of molnupiravir to dramatically increase access in India and other LMICs following regulatory approvals,” he said.

Additionally, these oral antivirals will lead to lower transportation and distribution costs compared to Covid-19 intravenous antivirals such as Ronapreve (casirivimab / imdevimab) or Veklury (remdesivir).

Having a solid and compact form, oral medications do not require confinement of the glass vials and the tablets can be packaged tightly without risk of breakage. Likewise, a larger amount of the drug can be contained in a defined space, increasing the speed at which the drug can be dispensed, he added.

Tags : supply chain
Joan J. Dean

The author Joan J. Dean