For a century, the Indian Council of Medical Research (ICMR) was a little-known government body quietly studying illnesses in New Delhi, but during the COVID-19 pandemic, it has taken on a role akin to the US National Institute of Allergy and Infectious Diseases, headed by Anthony Fauci — a powerful agency that has become the controversial face of India’s struggle with the disease.
As the ICMR has acted as a key medical adviser to Indian Prime Minister Narendra Modi and the Indian Ministry of Health and Family Welfare, it has increasingly drawn criticism from the nation’s doctors and independent scientists, who have questioned its drug recommendations, as well as its lack of transparency on data related to SARS-CoV-2 variants that were first identified in India and are now spreading globally.
India struggled to curb the world’s fastest COVID-19 surge this summer, and public health experts are warning that the country is ill prepared to face a possible third wave of infections. Some of the ICMR’s decisions during the pandemic reflect the broad chaos that has dogged India’s overwhelmed government apparatus, and have ended up benefiting the pharmaceutical industry rather than the public, critics say.
Illustration: Louise Ting
In April last year, S. P. Kalantri, director of the Mahatma Gandhi Institute of Medical Sciences, a 1,000-bed hospital in the village of Sevagram, wrote to international scientific journal The Lancet, strongly criticizing the ICMR for signing off on the health ministry’s decision to recommend the malaria drug hydroxychloroquine as a COVID-19 therapy.
The medicine remained on India’s virus guidelines for almost a year after the drug, last year embraced by then-US president Donald Trump, was discarded as a treatment for COVID-19 in the US.
Kalantri’s hospital, named after the Indian independence leader who had his last residence in the village, refused to prescribe that and other unproven treatments.
However, desperate patients simply sought them out elsewhere, Kalantri said.
“Countrywide, the doctors started writing these prescriptions, which artificially inflated the cost for COVID management,” Kalantri said. “Big pharma was laughing all the way to the bank, and ultimately the one who suffered was the poor patient — it’s where the science failed in India.”
Numerous therapies initially looked promising, and the ICMR’s guidelines are constantly evolving as trial evidence emerges, said Aparna Mukherjee, a New Delhi-based senior scientist at the ICMR.
“It’s very easy to criticize when something is put forward,” she said in an interview. “When you know there is some possibility that this drug might work, then just because it is in shortage, you cannot say: Don’t use it.”
Like other Indian government health agencies, the ICMR has been “stretched thin” during the pandemic, Mukherjee said.
Spokespeople for the ICMR and the health ministry did not respond to requests for comment.
However, criticism of the ICMR does not stop there. Over the past year, the government and the ICMR have also been accused of withholding data about the pandemic and the virus’ variants that left physicians in the country flying blind, and of promoting a homegrown COVID-19 vaccine before it had passed key clinical trials.
Public health experts say that it is not clear how the ICMR decides which COVID-19 drugs to back and have complained that the agency has not fully disclosed how much funding it provided for the locally developed vaccine.
Such moves have made the ICMR emblematic of India’s struggle with the disease, exemplifying problems in the country’s social and political fabric that have existed for decades and lingered under Modi — from a lack of transparency to an underfunded healthcare system.
The government needs “better evidence making and policy advice from the ICMR,” said Shahid Jameel, a virologist who in May resigned as chairman of the government’s advisory panel on SARS-CoV-2 genome sequencing after criticizing India’s pandemic response.
The ICMR has also drawn criticism on social media from scientists and healthcare advocates for its decisionmaking and recommendations, at times also attracting attention overseas.
“The Indian Council of Medical Research has been singled out by experts for straying from scientific evidence, appearing at worst politically motivated and at best overly optimistic,” a Lancet ediorial said in September last year, discussing the dangers of the “false optimism” that the government was projecting even as virus cases continued to rise.
The pandemic has killed more than 400,000 people in India, numbers that experts say are vastly undercounted.
As infections surged this summer, hospitals ran short of life-saving oxygen, and infected people died in the streets.
On July 7, Indian minister of health and family welfare Harsh Vardhan resigned amid a broad Cabinet reshuffle by Modi, whose popularity has taken a hit over the government’s handling of the pandemic.
However, the ICMR has not changed.
Headquartered in New Delhi, opposite the Indian Parliament, the ICMR was set up in 1911 by British colonial rulers and was traditionally focused on research. COVID-19 thrust the organization into the uncharted waters of actually managing an outsized viral outbreak.
In past epidemics, the Indian National Center for Disease Control (NCDC) — which has several infectious disease experts on its board — has played a bigger role, yet the ICMR has become the more public face of India’s response to COVID-19, a development some scientists questioned.
NCDC Director Sujeet Kumar Singh did not respond to an interview request.
Mukherjee acknowledged that the ICMR’s remit had widened during the pandemic, saying that it was due to the “need of the hour.”
It has taken on added responsibilities such as testing and procurement of diagnostic equipment, she said.
Funded through the health ministry, the organization has a budget of 23.5 billion rupees (US$316 million) this year and backs hundreds of scientist fellowships.
ICMR-linked researchers published more the 800 papers in Indian and international journals, its last annual report showed.
Since 2018, it has been headed by Balram Bhargava, a cardiolologist.
The ICMR has several experts focused on diseases like malaria that have traditionally been India’s biggest public health concerns, but few virologists work for the agency.
Bhargava did not respond to multiple requests for an interview.
With Indian states easing lockdowns, despite only about 6 percent of the population being fully vaccinated, the country is at risk of new waves of infection.
However, experts question whether India’s health network will be better prepared when the next resurgence comes.
“There is a distinct uneasiness in the scientific community on the government’s handling of the pandemic,” and the “opaqueness of the process of consultations, consensus building, data sharing and decision making,” said Lalit Kant, who headed the ICMR’s epidemiology and communicable diseases division for 13 years until 2011. “If we want the third wave to be managed appropriately, then we need evidence-based insights.”
In April, almost 300 Indian scientists and medical researchers appealed to Modi to allow them access to data that could help study, predict and curb the spread of COVID-19.
While the ICMR has data on all Indians who have been tested for COVID-19 so far, it restricts access, they say.
“The ICMR database is inaccessible to anyone outside of the government and perhaps also to many within the government,” the scientists wrote. “While new pandemics can have unpredictable features, our inability to adequately manage the spread of infections has, to a large extent, resulted from epidemiological data not being systematically collected and released in a timely manner to the scientific community.”
The ICMR conducted some of the most comprehensive serological surveys last year, including studying the presence of antibodies in various groups. It also published research on mortality rates during the country’s devastating second wave of COVID-19.
Scientists outside of the government system have said they have not had access to this data.
Some of them said that this gatekeeping of crucial information on the genomic makeup of local SARS-CoV-2 variants, testing and immune response to vaccines has left India flying blind as it contends with the new and highly infectious Delta variant, which was first identified in the South Asian country and is now spreading worldwide.
“Granular data on antibody surveys, clinical severity of disease, demographics, etc., has not been made available in the public domain,” Jameel said. “Open data would have allowed better modeling, better preparation and perhaps saved lives.”
Mukherjee said that there are no constraints on data and anyone with a proper proposal can access it, although she did not elaborate on what criteria they needed to meet.
The ICMR’s work with local company Bharat Biotech International on the homegrown COVID-19 vaccine has also drawn criticism from the scientific community.
Earlier this year, the drug, called Covaxin, was approved by the government for emergency use before final trials were completed, a move doctors and public health experts said was premature and fueled widespread hesitancy.
While approvals in India are handled by the drug regulator, the ICMR helped finance the vaccine’s development, although it has not publicly said how much funding it provided.
The company, the government and the ICMR have also been criticized for not making the details of the intellectual property rights to Covaxin public.
Bharat Biotech said in a statement last month that it would pay unspecified royalties to the ICMR and the Indian National Institute of Virology.
VIRUS FRONT LINES
Bharat Biotech and the ICMR have published studies showing potentially encouraging results on the vaccine’s effectiveness against new variants.
However, because the papers have been authored by officials from the company and agency, scientists have pointed to conflict of interest issues.
Mukherjee declined to comment on Covaxin’s funding and intellectual property rights, but said that final trial efficacy data should be published soon in a peer-reviewed journal.
A Bharat Biotech spokesperson reiterated the statement.
Back on the front lines of the pandemic in Sevagram, Kalantri is mainly concerned about poor populations in rural areas, some of whom went into debt buying medicines.
Prices of some drugs — such as remdesivir, which was added to India’s guidelines in March last year — soared more than 10-fold on the black market.
Remdesivir is approved and used for COVID-19 treatment in the US and elsewhere, but the WHO has said that there is not enough evidence to back it as therapy because the drug has not shown to increase COVID-19 survival rates.
Its widespread use in India was particularly devastating because many had to pay for it out of pocket in a country where few have medical insurance and average incomes are less than US$160 a month.
Experts and organizations including the All India Drug Action Network, an umbrella group of nonprofits advocating drug access in India, have been critical of the country’s continued advocacy of remdesivir.
Gilead Sciences, the drug’s manufacturer, did not respond to a request for comment.
Mukherjee said there was little the agency could do about price increases in the black market.
Convalescent plasma therapy, too, remained on the list for months despite the ICMR’s own studies in November last year finding little benefit.
Until late last month, the guidelines also recommended ivermectin, an anti-parasitic treatment that was untested against COVID-19, even though the WHO discouraged its use as far back as March.
“I’m very sad and disappointed,” Kalantri said about the ICMR.
Meanwhile, even with the pandemic at its peak in India this summer, an index of local pharmaceutical stocks advanced 21 percent this year, and Alliance Bernstein estimates that drugmakers’ sales volumes in May surged 36 percent from a year earlier due to COVID-19-related demand.
The pandemic highlighted India’s failure to improve its medical institutions, which are “weak and functioning sub-optimally,” said Chandrakant Lahariya, a New Delhi-based epidemiologist and public health expert who has coauthored a book on India’s battle against COVID-19.
“It is not merely about the COVID-19 pandemic response, but also about preparing Indian institutions for the future,” Lahariya said. “That opportunity seems to have been lost.”
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