With six Indian pharma companies working to manufacture antiviral pill Molnupiravir, healthcare experts say the game-changing drug will give India an effective and affordable weapon against the COVID-19 pandemic.

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The oral drug, which is likely to get Emergency Use Authorisation (EUA) in India in the coming weeks, is expected to help the country fight future waves if any. Molnupiravir, developed by global pharma major Merck, inhibits replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. It is reported to have the potential to completely eliminate SARS CoV-2 from the body within 5 days.

Earlier this month, the drug regulator in the UK gave approval to the pill, which will be given twice a day to vulnerable patients recently diagnosed with COVID-19. It was in June that five major pharma companies announced a collaboration for the clinical trials of Molnupiravir for the treatment of mild COVID-19 in an outpatient setting in India. It was the first such collaboration in the Indian pharma industry.

Hetero Pharma also has a non-exclusive licensing agreement with Merck to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries (LMICs). Hetero announced in July the interim clinical results from Phase 3 clinical trials of Molnupiravir in mild COVID-19 patients conducted across multiple COVID-dedicated hospital sites across India.

According to the company, the trials demonstrated statistically significant fewer hospital admissions, faster time to clinical improvement, and early negative SARS CoV-2 RT-PCR results with Molnupiravir treatment in mild COVID-19 patients compared to Standard of Care alone.

"Six Indian companies have the license to manufacture the generic Molnupiravir. It provides a great opportunity for global supplies. India will have another affordable and convenient weapon in addition to vaccines to fight future waves if any," distinguished cardiologist and health systems expert Dr Krishna Reddy Nallamalla told IANS.

He believes Molnupiravir may emerge as the game-changer in the fight against COVID as the studies show it can reduce the risk of hospitalisation or death in newly-diagnosed patients.

Dr Reddy who is the president of InOrder, a nonprofit institute working to strengthen systems to secure the health and also regional director (South Asia) of global health nonprofit, ACCESS Health International, said Molnupiravir as an effective oral drug for the treatment of COVID-19 assumes significance at a time when the world continues to witness daily positive cases of half a million despite the development of vaccines, which are not as effective against the spread of the virus and which lower efficacy against certain variants.

Dr K. Shivaraju, head, internal medicine, KIMS Hospitals, Hyderabad, points out that the oral drug has the potential to change the course of treatment by replacing Remdesivir. Unlike Remdesivir, Molnupiravir will not only be more effective but will be affordable. While Remdesivir is injectable and has to be given to patients in hospitals, Molnupiravir is an oral pill that can be given in an outpatient setting.

According to him, the most significant outcome of the development will be the drop in the cost of treatment. "The cost of each vial of Remdesivir is very high and compared to this the cost of the oral drug will be low and its efficacy is also good enough," he said. Shivaraju also pointed out that according to the World Health Organisation (WHO) there is no evidence that Remdesivir improves survival among Covid patients.

"The results (of Molnupiravir) are encouraging. We have been discussing this for the last six months or a year. We did not have a choice then. Remdesivir had to be given. Definitely, Molnupiravir should be effective and useful. The most important aspect is that the cost will come down for the patient," he said.

Shivaraju said the effectiveness of any anti-viral drug will be better when double-blind randomised clinical trials are conducted with the participation of over 1,000 patients. "From a medical point of view, double-blind randomised trials will have lot of significance. It gives a boost that this drug can be given to patients without much discomfort," he added.

Hetero had commenced a phase 3, comparative, randomised, multi-centre clinical trial on 1,218 mild COVID-19 patients. These clinical trials were aimed at evaluating the efficacy and safety of Molnupiravir plus standard of care (test arm) versus standard of care alone (control arm), in mild COVID-19 patients with a positive SARS CoV-2 RT PCR test for COVID-19 and randomised within 5 days of onset of symptoms.

Patients in the clinical trial were randomised to receive either Hetero's Molnupiravir capsules 800 mg (4 x 200 mg) every 12 hours (twice daily) for 5 days along with the standard of care as per the Indian Council of Medical Research (ICMR) guidelines or, in the control arm, to receive standard of care alone.

The company said the interim results from 741 mild COVID-19 patients revealed encouraging outcomes. Under the licensing deal with Merc, Hetero will be allowed to expand access to Molnupiravir in India and in other low-and middle-income countries, following the approvals for emergency use authorisation by local regulatory agencies. "We are vertically integrated to manufacture and commercially ready to supply this product to patients swiftly across the country," Dr B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies had said.

Molnupiravir will be manufactured in Hetero's world-class formulation facility in Hyderabad, which has been approved by stringent global regulatory authorities such as USFDA and EU, among others. Cipla Ltd, Dr. Reddy's Laboratories, Emcure Pharmaceuticals, Sun Pharmaceutical Industries, and Torrent Pharmaceuticals Ltd announced the collaboration to conduct clinical trials in June. This was the first such collaboration for a clinical trial within the Indian pharma industry.

Between March and April this year, these five pharma companies individually entered into a non-exclusive voluntary licensing agreement with Merck to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries. Under the collaboration agreement, the five pharma companies will jointly sponsor, supervise and monitor the clinical trials in India. As per the directive of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation, Dr Reddy's will conduct the clinical trial using its product, and the other four pharma companies will be required to demonstrate equivalence of their product to the product used by Dr Reddy's in its clinical trial.

The trials were expected between June and September across India with the recruitment of 1,200 patients. On successful completion of the clinical trial, each company will independently approach the regulatory authorities for approval to manufacture and supply Molnupiravir.