Generic drugs

India to become hub for generic Covid-19 antiviral drugs: Fitch

India will become the world’s largest production hub for general 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, said Fitch Solutions on Friday.

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

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

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

“This will make India the world’s largest hub for the production of generic Covid-19 antiviral drugs,” he said. “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 over its risk of inducing harmful mutagenesis if the drug is prescribed globally, creating the potential for new strains of Covid-19.

The second wave of Covid-19 in India peaked in April and May 2021 when daily average cases exceeded 4 lakh. The number of cases has fallen 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 117,100, with 3,007 cases confirmed to be the Omicron variant, according to the Union Health Ministry.

“Additionally, India continues to lag behind in its Covid-19 vaccine rollout target as 44.5% of the population has been fully vaccinated,” Fitch Solutions quoted Our World In Data as saying. “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 (LMIC) countries, while simplifying current supply chain barriers, he said.

A full five-day course of molnupiravir in the US costs around $712 ( 52,909). Generic versions of the drug will cost between 18.79 USD (approximately 1,400) at $21.48 (approx. 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 ( 35) per capsule and $18.79 ( 1,400) for a five-day course of 40 capsules.

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

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

Having a solid and compact shape, oral medications do not require glass vial containment requirement and the tablets can be packed tightly without risk of breakage. Likewise, more drug can be contained in a defined space, increasing the rate at which the drug can be dispensed, he added.

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Tags : supply chain
Joan J. Dean

The author Joan J. Dean