It’s been over a month since the Medicines Patent Pool (MPP), a UN-backed body, announced a tie-up with 35 companies, including 19 drug manufacturers from India, to produce the generic version of Pfizer’s oral COVID-19 drug Paxlovid, the most efficacious antiviral therapy against the novel coronavirus so far.
Yet, there is no sign of the drug’s arrival in India, which is now witnessing a rise in COVID-19 numbers after a lull and is fearing that many infected may eventually need hospitalisation and intensive therapeutic management.
Paxlovid was found to reduce the risk of hospitalisation or death by 89 percent within three days of symptom onset and 88 percent within five days of symptom onset compared to placebos in mild to moderately high-risk COVID-19 patients in a large-scale clinical trial involving nearly 2,500 patients.
The drug was granted emergency-use authorisation by the US Food and Drugs Administration (USFDA) in December last year for those above 12 years of age.
Importantly, the antiviral therapy has been found to be effective against various variants of SARS CoV 2, including Omicron, whose several sub-lineages are now driving the pandemic around the world.
Clinicians who have managed some of the crucial centres treating COVID-19 patients in the country feel that it is important for India to quickly have the drug in its armamentarium, as signs of yet another pandemic surge emerge.
The therapy
Paxlovid consists of nirmatrelvir, which works by inhibiting a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations.
It is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets.
In the US, the drug is not authorised for use longer than five consecutive days and can be taken on prescription by those who are at high risk for progression to severe COVID-19, including hospitalisation or death.
The USFDA says the therapy should be initiated as soon as possible after a diagnosis of COVID-19 and within five days of symptom onset.
Why is it crucial for India?
Swapneil Parikh, a healthcare entrepreneur and author of the book The Coronavirus, told Moneycontrol that it was important for India to quickly possess the most effective antiviral treatment against COVID-19 as we transition to a phase of “living with the virus”.
In a country as populous as India, said Dr Parikh, there is also a large group of people vulnerable to serious COVID-19 despite vaccinations, booster doses or prior infection.
“Given that monoclonal antibodies have become outdated with the advent of Omicron and its sub-lineages and there are hardly any other targeted therapies against COVID-19, India should have Paxlovid as an option for high-risk patients,” he added.
The sentiment is echoed by Dr Yatin Mehta, head of department, critical care medicine at Medanta Medicity, a specialty hospital chain based in Gurugram outside Delhi.
“I don’t know why it is taking so long for Indian manufacturers to launch this drug in India but Paxlovid, given its high efficacy against Omicron, should prevent many high-risk patients from landing up in hospitals,” Dr Mehta said.
He also pointed out that molnupiravir, a COVID-19 drug launched in India with much fanfare, had an efficacy of just about 30 percent against existing virus variants.
Dr Anupam Singh, a physician and infectious disease expert based in Ghaziabad, near Delhi, too said that Paxlovid may be more beneficial than currently available oral options for outpatient therapy of COVID-19 like molnupiravir, which has suboptimal efficacy and genotoxic concerns, and fluvoxamine.
Paxlovid would be especially useful in groups where vaccine efficacy is not as well such as the elderly who have not received their booster vaccine shots, transplant recipients, and immunocompromised patients, according to Dr Singh.
The drug may have its own set of problems such as interactions with other drugs, particularly with blood thinners and cholesterol-lowering medicines but Dr. Singh pointed out that these can be taken care of by using alternative medicines for these conditions, under the watch of a clinician.
Costing concerns
Pfizer did not respond to a query by Moneycontrol on the delay in availability of the drug in India, nor did Torrent and Aurbindo Pharma, two of the 19 companies that have entered into an agreement to manufacture Paxlovid in India.
But sources in the Union health ministry said that ongoing negotiations on the pricing of the drug in the country and discussions around its local clinical trials may have delayed its launch.
The drug costs the US government $530 or a little over Rs 40,000 for a five-day course.
Dr Singh too said that a major concern around Paxlovid, whenever it is made available, is that it may be far more expensive than alternatives.
Even generic versions of this drug in Bangladesh are available for around $200 or more than Rs 15,000 for a single course of therapy, he pointed out.
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