The Indian Council of Medical Research (ICMR) is playing safe with its stand against anti-coronavirus pill molnupiravir but its decision conflicting with the drug regulator’s position will leave doctors confused, said Dr Govindarajan Padmanaban, a key member of the national Covid task force.
The former director of the Indian Institute of Science in Bengaluru leads the committee under the task force on new Covid vaccine development.
“ICMR could be right in terms of playing safe but we need to keep our eyes open. It’s surprising that CDSCO has approved the drug and now ICMR is not allowing the drug use,” he said.
CDSCO – the Central Drugs Standard Control Organisation – is an apex body to regulate and approve drugs, vaccines and medical devices in India. It is headed by the Drugs Controller General of India, VG Somani.
Dr Padmanaban added that the decision of the CDSCO also holds value as “we must consider that CDSCO is also not an individual who is clearing the drug but it is also advised by a subject expert committee, followed by DCGI’s approval”.
The CDSCO is a body under the ministry of health and family welfare, similar to the ICMR, he pointed out, while adding that “in such matters, both of these bodies should be on the same page and approve or disapprove drugs for use in India. If not, this will leave the doctors confused.”
Dr Padmanaban, science and innovation adviser at BIRAC (Biotechnology Research Assistance Council, Department of Biotechnology, Government of India) said that another reason for not adding the drug in the national treatment protocol could be that molnupiravir may cause complacency against vaccination.
“The other concern of not adding this drug in national treatment protocol could be the anticipated complacency in taking vaccines and precautionary shots or boosters,” he said. “People may think that now the drug is available against Covid and they may postpone or not take vaccines.”
A past president of India’s National Academy of Sciences, Dr Padmanaban said the last chance for the government to use Biological E’s Corbevax and Gennova’s mRNA vaccine is to use them as boosters; otherwise, they will go for export.
‘ICMR looking for more safety data but must keep open mind’
One of the main concerns of ICMR against molnupiravir, it seems, is self-medication and overdosing, said Dr Padmanaban. “It is clear that the drug should not be taken in pregnancy or by lactating women. Except for this side effect, there is no clear data on other side effects mentioned by ICMR,” he said.
ICMR and experts at the national Covid task force have decided not to go ahead with molnupiravir.
“We have to keep an open mind as we don’t have any antiviral drug that can be administered in the home setting. While there are many benefits of having a pill, its disadvantages are self-medication and over-consumption,” he said. “I believe that ICMR is looking at more safety data from India considering that we need to know potential side effects among the Indian population. Internationally, only one trial data is available with a small sample size.”
Once approved by CDSCO, companies have now started manufacturing the drug, Dr Padmanaban pointed out. “Once they get the marketing licence, they will start selling the drug. Considering the weak prescription market in India, people can get away with buying the drug without prescriptions.”
‘India should give boosters to all’
India has to go for booster doses, eventually, said Dr Padmanaban. “In my view, boosters should be given to everyone to give long-term protection. After the second dose, several weeks have passed by. With lower antibody levels, third wave setting in, virus mutating, we need to take a call on boosters eventually for all, although initially the over-60 age group with co-morbidities may be the target,” he said. “We must remember that Omicron is not the last coronavirus.”
However, Dr Padmanaban said he believes the SARS CoV-2 coronavirus is on its way out and may become endemic in the coming years. The virus is becoming more transmissible and less virulent (lethal) – which is the exact characteristic of virus progression towards endemicity, he added, stating that, in his opinion, the virus will become weaker and weaker in the coming months.
What happened to Corbevax, Gennova’s mRNA vaccine?
International studies have shown that a mix-and-match strategy for boosters works well and it might be a good idea for India to try the same, said Dr Padmanaban.
“We have enough vaccines available for mixing including Biological E’s Corbevax, recombinant spike protein,” he said. “The DNA vaccine was approved some time back, but hasn’t entered the market. The 12-18 year age group is projected as the target. mRNA vaccine is also round the corner.”
If they are not allowed as boosters, they have to look for entirely different sections of beneficiaries, Dr Padmanaban said. “Government only supported all these vaccine makers but it doesn’t look like we will be able to use their vaccines if not used as boosters.”
The concern of the government, Dr Padmanaban said, is that data is not available on the efficacy and safety of mix and match. “Maybe we should use data generated outside India for this purpose, but Covaxin is essentially used in India. It is yet to reach 20% of the supply.”
However, if they do not use these vaccines, there is a big market for export, he pointed out, adding, “Many countries are waiting for vaccine supplies.”
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