Cover story

Information void

Print edition : July 17, 2020

The Commonwealth Games Village indoor stadium in New Delhi being converted into a COVID-19 care centre, on June 30. Photo: PTI

In the Karol Bagh neighbourhood of New Delhi, identified as a COVID-19 containment zone, on June 29. Photo: Manvender Vashist/PTI

Dr Vinod K. Paul , Member (Health), NITI Aayog (second from left), Dr Balram Bhargava, Director General, ICMR (third from left) and Lav Agarwal, Joint Secretary, Ministry of Health & Family Welfare (left), at a press conference on COVID-19 preparedness and action taken, in New Delhi on June 11. Photo: pib

The COVID-19 situation seems headed for a climax, but the government is reticent about sharing information and statistics regarding the infection and the treatment protocol.

THE government at the Centre has consistently sought to give the impression that the COVID-19 situation is under control and that measures to contain the contagion have been adequate. Yet, the number of confirmed cases has been rising steadily across the country, and the pace of testing is hardly commensurate with the magnitude of the spread of the virus. The “unlock phase” was expected to bring substantial answers and explanations from the government and the scientific establishment on where India stood among nations on the various parameters of this health emergency. Yet, the flow of information in the public domain, which was quite excessive in the beginning of the lockdown, reduced to a trickle in May and June, especially in June when cases started to spike seriously.

On June 29, a brief press release from the Ministry of Health and Family Welfare made a desperate attempt to present an optimistic picture. It stated that the recovery rate had gone up to 58.67 per cent, that the number of recoveries had sharply overtaken the number of active cases, and that testing numbers had crossed 2.3 lakh samples a day. The gap between “recovered” and “active” cases had widened to 106,661, as of June 28. A total of 3,21,722 patients had been cured, and there were slightly over two lakh active cases under “active medical supervision”. There were 1,047 designated COVID-19 diagnostic laboratories, and more than 50 per cent of these were government labs. Close to 84 lakh samples had been tested. It provided details of COVID-related health infrastructure such as the list of dedicated hospitals and the number of isolation and intensive care unit (ICU) beds. This information is important and welcome, but there are also many unanswered questions regarding the trajectory of the virus, on which both the government and scientific establishment have been tight-lipped.

The number of press briefings from the government has not been quite commensurate with the steeply rising graph of confirmed cases and infections. The regular briefings that were held at the beginning of the lockdown petered out in late May. In June, the last one was held on June 11, where the results of the first phase of a serological survey, which showed that 0.73 per cent of the general population had been infected, were shared with the media. After that, only press notes were issued, a form of communication that precluded questions from the media. In the 17th meeting of the Group of Ministers on June 17, its members were informed that Maharashtra, Tamil Nadu, Delhi, Telangana, Gujarat, Uttar Pradesh, Andhra Pradesh and West Bengal contributed 85.5 per cent of the active caseload and 87 per cent of the total deaths until then. The affected States and Union Territories had been asked to focus on containment measures and surveillance, use maximum testing capacity, monitor the comorbid and elderly population, predict emerging hotspots, and leverage digital tools, the GoM was told. The press note did not say whether the GoM was briefed on the number of deaths and the incidence of the infection in the population.

More people are being tested, which is a positive thing, though there are wide variations in the numbers among the States. The testing strategy of the Indian Council of Medical Research (ICMR) was revised to ramp it up following much media attention on the almost stagnant rates of testing prevalent earlier. But testing levels, which increased mostly in June, still do not match up with those in other countries with comparable populations and confirmed cases. That States and Union Territories have been asked to fully utilise their testing capacity means that the testing capacity of laboratories is still heavily underutilised.

Questions on approval of drugs

There have been serious issues about sharing information in the public domain, in particular about treatment protocol. On June 26, the All India Drug Action Network (AIDAN), a broad coalition of civil society organisations working on drug policy, wrote to the Drug Controller General of India (DCGI) regarding the need for transparency in the functioning of a special Subject Expert Committee (SEC) that had been formed to evaluate COVID-19 drugs, health products and their approval process. The AIDAN pointed to serious gaps in information, beginning with the composition of the committee itself, which, it said, was shrouded in secrecy.

The process behind the regulatory and marketing approval of COVID-19 drugs like Remdesivir and the anti-viral Favipiravir by the Central Drugs Control Standard Organisation (CDSCO) was unclear, the AIDAN said, as the SEC report was not in the public domain. On June 22 the DCGI granted formal approval for Favipiravir to Glemnark Pharmaceuticals and for Remdesivir injection to Cipla Ltd and Hetero Drugs. Though the approval for the latter had been given on June 19, it was notified on June 22.

The DCGI notice said: “Considering the emergency and unmet medical need for COVID-19 disease, CDSCO has approved Restricted Emergency Use of Remdesivir Injectable Formulations for the treatment of patients with severe COVID-19 infection and Favipiravir tablets for mild to moderate COVID-19 infection subject to various conditions and restrictions.” The import and marketing of Remdesivir had been approved on June 1 itself, but it turned out that the importer was yet to import the drug after taking an import licence from the CDSCO. On June 20, the CDSCO granted permission to indigenous manufacturers for the manufacture and marketing of injectable formulations of the drug to ensure early access of Remdesivir for treatment of severe COVID-19 cases under the Restricted Emergency Use. Both drugs were to be sold with prescriptions. Remdesivir formulations, in particular, were to be supplied only to hospitals and institutions to ensure proper use. I In both cases, informed consent of the patient or his/her representative was mandatory.

The AIDAN letter to the DCGI pointed out that in March 2020 the CDSCO had notified a regulatory pathway for approvals of COVID-19 drugs and vaccines. While approvals were given for the two drugs concerned, there was no official information regarding the basis for the accelerated approval. There was no clarity in the manner in which the regulatory pathway was being implemented. It was unclear whether Gilead, the manufacturer of Remdesivir, had submitted trial data or whether that data were submitted in peer-reviewed journals and whether the SEC had examined independent trials. The approvals to two other companies to manufacture the drug also lack clarity on the extent of data provided by the companies—data on stability, impurity profile, assay (an investigative procedure in laboratory medicine) for the products produced in India.

The AIDAN said that authorisations and experimental data ought to be placed in the public domain for the sake of public safety. In the case of Favipiravir, it said, there was no information about studies and data submitted by the manufacturer for marketing approval. No trial data had been published, and the drug itself was under trial in many countries and its efficacy in treating COVID-19 was not proved.

The AIDAN emphasised the importance of clinical evidence and said health care workers needed information on the possible side effects of drugs, which was all the more reason why trial data should be made public. Authorisations could be granted under emergency conditions such as the one created by the COVID crisis and the waiver of trials and approvals was a possibility. But that made it all the more imperative, the AIDAN said, that the recommendations of the SEC should be made public. In a situation where emergency or experimental treatments are administered to patients, they and their families have a right to know what kind of drugs are being administered. The organisation expressed regret that at a time when greater transparency was needed, the CDSCO had become more opaque.

This lack of transparency had perhaps created a situation that made it possible for Yoga guru Ramdev’s Patanjali Ayurveda Limited to claim that it had a cure for COVID-19. On June 23, it launched a “corona cure kit” with two medicines, “Coronil” and Swashri Vati. Ramdev claimed that a controlled clinical study was done, that 100 people were tested and that within three days 65 per cent of people who were found positive tested negative. “Coronil” apparently had a 100 per cent recovery rate. The media were informed that the drug would be available in all Patanjali stores within a week. What he did not say was that the recovery rate in any case was close to 99 per cent or more, considering that recent sero-surveillance data had revealed the infection fatality rate to be 0.08 per cent.

News of this “breakthrough cure” spread like wildfire and was discussed endlessly on electronic and social media. As sections of the media began asking questions about the miracle cure, the Ministry of AYUSH (Ayurveda, Unani, Siddha and Homeopathy), the nodal Ministry responsible for granting permission for clinical trials for treatments under the AYUSH stream, issued a press release stating that the claim and the scientific study on which it was based were not known to the Ministry. Patanjali was told to “stop advertising/publicising such claims till the issue was duly examined”.

The Uttarakhand government’s licensing authority was requested to provide “copies of the licence” and “product approval details” of the Ayurvedic medicines being claimed as COVID cures. A representative of the licensing authority told the news agency ANI that it had issued Patanjali a licence for only immunity boosters. In addition, the licence officer of the State Ayurveda Department told ANI that a notice would be issued to Patanjali demanding details about the identity of the agency that had authorised it to manufacture a COVID kit.

The Ministry denied knowing anything about the “facts and claims pertaining to a certain scientific study by the Haridwar based Patanjali Ayurveda Limited” and asked Patanjali to furnish the details of the name and composition of the medicines being claimed for COVID treatment, the sites or hospitals where the research study was conducted, protocols, sample size, institutional ethics committee clearance, registration with the Clinical Trials Registry of India (CTRI) and results of the data and studies conducted.

Interestingly, Patanjali had tried to conduct trials in Indore claiming that the District Magistrate had given it permission. When health activists objected saying the Collector did not have the authority to give permission, the Collector himself issued a statement clarifying that he had given no such permission. The company then tied up with the National Institute of Medical Sciences (NIMS), a private medical college in Jaipur. But soon enough, the chairman of NIMS dissociated the institute from all such claims of a cure.

He told a section of the media that no clinical trials were held of the kind claimed and that only some symptomatic patients were given medicines sponsored by Patanjali. He also said that permission from the CTRI had been taken for doing tests with Ayruvedic medicines to check their effectiveness as immunity boosters and not for a cure. The Rajasthan Health Department, caught unawares, announced that the drug would not be allowed to be sold in the State.

The issue at hand was that no government, Centre or State, seemed to be in the know of what was happening, even as spurious claims, like the one made by Patanjali, were floating around. With the Prime Minister himself constantly acting as a brand ambassador of Ayurveda, it was clear that nobody in the scientific establishment dared to say anything to the contrary. The AYUSH Ministry had to speak out as the claim by Patanjali would have definitely caused embarrassment to the government in the global scientific community, more so as India itself was working on finding a vaccine.

Vulnerability of health workers

There is lack of transparency at other levels, too, especially with respect to information on the vulnerability of health workers and health professionals. On June 28, a consultant anaesthesiologist at the prestigious Lok Nayak Jai Prakash Narain Hospital in New Delhi, a COVID hospital now, succumbed to the virus. He was working in the hospital’s ICU. The concerns of health workers do not seem to have been addressed adequately, notwithstanding the use of the fanciful title of “corona warriors” by the government. There is so far no centralised data base on the number of infected health workers or the number of health workers who died treating coronavirus patients. Media queries in this regard were generally ignored.

Private agencies have stepped up to fill the information void. Three Bengaluru-based independent researchers, Savithri Devi, Subha Sri and Shrinidhi Datar, conducted an online survey of around 392 health workers in May to investigate the availability of personal protective equipment (PPE). They interviewed doctors, nurses, community health workers, post-graduate residents and interns in public sector facilities spread across 26 States and 150 districts. The findings revealed that “most components of PPE were either inadequately available or not available at all in most health care settings”.

More than 50 per cent of the respondents surveyed were from badly affected States such as Maharashtra, Tamil Nadu and Madhya Pradesh. The researchers found that more than one third of those in the outpatient departments of public hospitals did not have N-95 masks; one in five working in operation theatres and less than one-third in labour rooms had face shields; 27 per cent of the respondents who worked in wards and four out of eight in ICU settings had N-95 masks. One in five working in red zone districts said they did not have N-95 masks. Only a quarter of community health workers doing contact tracing and door-to-door surveillance had masks and less than one third had gloves.

The survey found that 14 per cent of health care workers, including those in red zone districts, purchased their own PPEs and one-third of all respondents reported that they reused PPEs. But 88 per cent did not have adequate knowledge of the PPE recommended for their work settings. The respondents complained of discomfort wearing the PPE in hot conditions, of discrimination in the distribution of PPEs, and so on.

Frontline spoke to Accredited Social Health Activists (ASHAs) and other National Health Mission staff in Haryana, who said that there were acute shortages of PPEs and sanitisers.

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