India will become the largest global hub for COVID-19 antiviral general drug production after the drug controller granted Emergency Use Authorisation (EUA) to several pharmaceutical companies in the country to manufacture and market generic versions of Molnupiravir, Fitch Solutions said recently.

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

Those granted authorisation by 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 the authorisation, Cipla, Sun Pharma and Dr Reddy’s Laboratories are set to release Molnupiravir capsules in the coming weeks, and the rest of the companies will follow.

“This will make India the largest global hub for COVID-19 antiviral generic drug productions,” it said. “The efficacy of Molnupiravir during its MOVe-OUT phase-III trial has been largely promising, with a 50 per cent reduction in hospitalisation and death in early-stage infections.”

However, safety concerns remain on its risk of inducing harmful mutagenesis if the drug is prescribed globally, creating the potential for new COVID-19 strains.

The COVID-19 second wave in India peaked during April and May 2021 when daily average cases topped four lakh. Caseloads have dropped significantly since then, with the national tally remaining one under 10,000 cases per day for the rest of the year.

However, in recent days, there has been a surge in daily COVID-19 cases driven by the Omicron variant which is set to overtake Delta as the dominant variant.

On 6th January, COVID-19 cases increased to 1,17,100 with 3,007 of these cases confirmed as the Omicron variant, according to the Union Ministry of Health.

“Moreover, India continues to lag behind in its COVID-19 vaccine rollout target as 44.5 per cent of the population has been fully vaccinated,” Fitch Solutions said quoting Our World In Data. “Therefore, given the slow vaccination and recent sharp rise in COVID-19 cases, generic versions of Molnupiravir could significantly reduce risk of hospitalisation admission or deaths.”

Generic Molnupiravir will increase access in India and other Low- and Middle-Income Countries (LMICs), while simplifying current supply chain obstacles, it said.

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

For instance, Dr Reddy has set the price of its Molnupiravir generic version, 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 Molnupiravir generic versions to significantly increase access in India and other LMICs after regulatory approvals,” it said.

Moreover, these oral antiviral drugs will lead to lower costs of transport and distribution compared with COVID-19 intravenous antivirals such as Ronapreve (casirivimab/imdevimab) or Veklury (Remdesivir).

Having a solid, compact form, oral drugs does not need containment requirement of glass vials and the tablets can be tightly packed without risk of breakage. Similarly, a larger quantity of the drug can be contained within a set space, increasing the rate at which the drug can be distributed, it added.