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Antiviral Molnupiravir not in govt Covid protocol, but ‘millions of doses’ distributed in a week

New Delhi: Millions of capsules already distributed, doctors placing pre-orders — within a week of its launch, Molnupiravir manufacturers are already seeing increased demand for the drug as India faces a third wave of the pandemic dominated by the Omicron variant of the coronavirus. 

Although the antiviral drug was approved by the Drugs Controller General of India (DCGI) last month for Covid treatment, the health ministry has not included Molnupiravir in its Covid protocol.

According to the US Food and Drug Administration, Molnupiravir works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. 

Molnupiravir is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules. It is not authorised for use for longer than five consecutive days. 

Since its approval by the DGCI, the drug has garnered a lot of interest. However, even as various pharmaceuticals announced the launch of Molnupiravir, Indian Council of Medical Research (ICMR) director general Balram Bhargava in a press briefing said that the drug was not included in India’s Covid treatment protocols due to safety concerns. 

Similarly, as reported by ThePrint earlier, doctors in India have expressed caution about prescribing the new drug, citing several concerns and saying that it’s best to go by protocol.

Nevertheless, the numbers in the market show that doctors have begun ordering the drug, and several manufacturers in the country are gearing up to supply it, not just to India but also to more than 100 other low- and middle-income countries. 

A spokesperson for Aurobindo Pharma told ThePrint, “Our company, through its distribution partners, has already distributed millions of Molnupiravir capsules in 270 cities in India.”

Also read: Antibody cocktails, oral pills: These are the Covid treatments available as Omicron surges

Pre-ordering, demand expected to soar

Nikkhil K. Masurkar, executive director at Entod Pharmaceuticals, told ThePrint that doctors working in community settings had begun pre-ordering Molnupiravir, with about 75,000 tablets (7,500 strips) already booked. 

“Since this product will be launched by our general division, it will be promoted to primary care practitioners and doctors (GPs, physicians) working in community settings, who will see the majority of Covid cases in the coming weeks,” said Masurkar.

“We are currently in the process of manufacturing our first batch. So, as of now we don’t hold any stock. But in the next two-three weeks, we’ll have 1-2 lakh capsules, which will be provided to doctors who have already pre-ordered the drug from us,” he added. 

Asked what he thought of the health ministry’s decision not to include the drug in the Covid treatment protocol, Masurkar said that since this is a newly approved antiviral drug, it is probably a little too early to include it in the national protocol.

“The government is exercising some caution, especially after what happened with remdesivir and hydroxychloroquine,” he said.

“Also, Molnupiravir is more intended towards home quarantine patients who have mild to moderate Covid symptoms, to stop the infection from getting more severe. It’s not being used in hospitals and is basically aimed at keeping a check on the infection from getting worse, especially in elderly people and those with comorbidities,” he said. 

He added, “We feel the demand will soar in the coming weeks as Omicron ravages India and more and more people are put into home isolation.” 

Also read: How Corbevax and Covovax, the two vaccines newly approved in India, fight Covid

Gearing up to supply to 104 low- and middle-income countries

Aurobindo Pharma Limited, which has also launched its brand of Molnupiravir —  Molnaflu —  across India, said that the company has adequate capacity to meet global demand for the product across 104 low-and middle-income countries.

Aurobindo is among several Indian generic manufacturers for Molnupiravir that have entered into non-exclusive voluntary licensing agreements with Merck Sharp Dohme, Singapore (MSD), a subsidiary of Merck & Co. (US), to manufacture and supply Molnupiravir to 104 low and middle-income countries, including India.

A spokesperson for MSD India told ThePrint, “We cannot speculate on the capacity of our voluntary licensing partners for the manufacture of Molnupiravir. However, we have granted licences to multiple generic producers with a history of supplying global health programmes to support supply security for access in low- and middle-income countries.” 

“Our allocation principles will strive for access across country economic levels.”

A spokesperson for Aurobindo Pharmaceuticals told ThePrint that despite not being included in the Covid treatment protocol, Molnupiravir is approved for use by medical specialists for specified groups of patients in India. 

“As of now, Molnupiravir (Molnaflu) is the only approved specific drug for treatment of a specified group of Covid patients. The specialist can assess for treatment of adult patients with Covid-19 who have oxygen levels over 93 per cent and high risk of progression of the disease including hospitalisation or death,” the spokesperson said. 

“This is an extremely useful addition to the medical armamentarium of a specialist,” added the spokesperson.

Meanwhile, R.C. Juneja, executive chairman of Mankind Pharma, told ThePrint, “We are all set to launch the economical Molnupiravir, the Covid-19 antiviral drug, at Rs 35 per capsule this week. The therapy cost of Molulife (brand name) will be Rs 1,400.” 

“Through this, we expect that the sales of Molulife will cross 50 crores in a year,” Juneja added. 

Molnupiravir is not authorised for use in patients younger than 18 years of age because the drug may affect bone and cartilage growth. Based on findings from animal reproduction studies, Molnupiravir may cause fetal harm when administered to pregnant individuals. Therefore, Molnupiravir is not recommended for use during pregnancy.

(Edited by Rohan Manoj)

Also read: US clears Merck’s Covid pill as it weighs how to ration Pfizer drug

Source: The Print

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