‘No Need to Stockpile Vaccines, Drugs’ Says NIV Head as India Issues Monkeypox Guidelines

The guidelines prescribe a two-tier test for confirmation but don’t present a clear algorithm on sample collection.

New Delhi: Twenty four days after the first case of monkeypox was confirmed during the current outbreak in the United Kingdom, the Union health ministry on May 31 issued guidelines for the diagnosis and management of the disease.

Over 30 countries in Europe, Americas, Africa and Oceania are currently reporting 600 confirmed cases of the disease. India has not reported any case till now. 

Insofar as the diagnosis of the disease is concerned, a case can be considered confirmed after a two-tier investigation, the guidelines say. 

First, the sample will be tested for different types of poxviruses including, cowpox, monkeypox, buffalopox and camelpox. If the specimen tests positive, then testing would be narrowed down for investigating monkeypox virus, specifically. 

All  samples have to be sent to National Institute of Virology [NIV], Pune [for confirmation] which has a biosafety level-4 lab facility,” its director Priya Abraham told The Wire

The guidelines are silent on who to contact if a clinician recommends a test. 

Indian Council of Medical Research’s additional director-general, Samiran Panda, told The Wire that the samples are currently being collected only from those travellers who are coming from countries where monkeypox cases have been reported; and also show symptoms. 

If a clinician recommends a test for a suspected case or a contact, who should one approach?

Panda said, “All designated labs of Integrated Disease Surveillance Programme [IDSP]. The sample will be collected there”. Every state has one IDSP unit. Under it, various IDSP labs function. But out of 734 districts in the country, only 397 have designated IDSP labs, as of February. The IDSP is a centralised system of disease surveillance in India that functions under the Union health ministry.

RT-PCR kits – the same kits used for novel coronavirus detection – are used for testing monkeypox samples. However, the probes and primers in monkeypox kits are different and are specific to monkeypox. These are, basically, two essential tools that actually help in amplifying a specific DNA fragment that is converted from the RNA of the collected sample. On amplification, it can be known if or not the DNA fragment is related to the virus concerned – in this case the monkeypox. 

The samples for monkeypox virus are different from that of SARS-CoV-2.

“The best diagnostic samples for monkeypox are from the skin lesions – the roof or fluid from vesicles and pustules [lesions filled with fluid], and dry crusts seen on the skin,” Abraham said. The lesion- roof sample is collected by scrapper and lesion fluid with an intradermal syringe. 

An electron microscopic (EM) image shows mature, oval-shaped monkeypox virus particles as well as crescents and spherical particles of immature virions, obtained from a clinical human skin sample associated with the 2003 prairie dog outbreak in this undated image obtained by Reuters on May 18, 2022. Photo: Cynthia S. Goldsmith, Russell Regnery/CDC/Handout via Reuters/ File Photo

“In addition, nasal and throat swabs can be also collected, particularly from febrile (those with fever) contacts of suspected or confirmed cases of monkeypox,” she said. 

Case definition

A suspected case, according to the guidelines, is one who has history of travel to one of the countries reporting monkeypox outbreak(s) within the last 21 days, presents an unexplained acute rash and has one of the following symptoms – swollen lymph nodes, fever, headache, body aches or weakness. 

A case can be confirmed only through RT-PCR test or through genome sequencing. 

Also read: Monkeypox Outbreak ‘Not Normal’ but ‘Containable’ Says WHO as Govts Ready Vaccinations

The guidelines say that even one case is good enough for it to be considered an outbreak. All contacts of a confirmed case have to be monitored for a period of 21 days starting from the day when they met the patient last as the disease can spread asymptomatically as well. 

B.K. Titanji, a virologist from Emory University, had told The Wire earlier that a long incubation period (up to 21 days) of the monkeypox virus provides it the scope of asymptomatic spread. She has been studying monkeypox outbreaks in African countries. A bigger incubation period means it would take a longer duration for the symptoms to appear after the infection. 

Treatment

The guidelines recommend that the patient has to be strictly isolated to prevent further spread of the virus. The isolation does not necessarily have to happen at a hospital. 

The disease is mostly self-limiting and lasts for 2-4 weeks. Currently, only symptomatic treatment for rashes, ulcers, fever, itching in lesions and other symptoms have been prescribed in the guidelines. They currently do not mention the use of the smallpox-specific antiviral, tecovirimat. 

Countries like the UK and the US recommend its use for monkeypox as well though the scientific data supporting its use is limited. The drug’s availability is in short supply across the globe mainly because countries never invested in its research and development as the disease was confined to the African nations. 

The US has already stockpiled the drug; as it has done in the case of smallpox vaccine. The latter has proven to be 85% effective against monkeypox as well. There are reports surfacing already that countries are ordering the vaccine in large quantities just in case the outbreak worsens. 

Asked if India would also be required to stockpile the vaccine, Abraham said, “This virus does not spread like SARS-CoV-2 [novel coronavirus], hence mass vaccination at this point of time may not be necessary.”  The World Health Organization has also not recommended any such campaign at scale, as of now, at least. 

She also ruled out the requirement of stockpiling of tecovirimat. “Isolation of sick patients who return from monkeypox-affected countries, surveillance strategy at airports and seaports, hospital infection control measures, contact tracing, isolation and increasing public awareness are all effective ways to contain an outbreak,”  the NIV director said. 

Though not a single case has been identified yet in India, or in fact, in southeast Asia, Abraham said the possibility of status quo could not be guaranteed. “With so much international travel now, cases are likely to be seen in India and Asia too.”  

Prescription for common people

For common people, the guidelines have simple advice to offer, including vigilance about symptoms. Skin rashes start to appear within 1-3 days of the onset of a fever. Tongue and mouth are where they begin. Face is the next target and gradually they spread to other body parts. They also become filled with fluid. 

By the end of the second week, they dry up and crust. But not everybody is prone to equal levels of skin manifestations. 

Those who either have compromised immune systems or have poor nutritional status or have any other parasitic infection are at greater risk of developing skin manifestations, the guidelines say. What also becomes a deciding factor is smallpox vaccination status. Smallpox was eradicated in 1980. Until then, smallpox vaccination was done at a community level. So those who have been vaccinated against smallpox are at lesser risk of getting infected or getting a serious disease if infected. 

India Needs a Surveillance Law That Goes Beyond Personal Data Protection

Increased surveillance as a result of the pandemic has sparked two questions – what measures should be taken until the PDP Bill is enacted and is there a need to enact a separate law?

A large part of the current effort between the Union and state governments in contact tracing, widespread testing, disease surveillance and quarantining is being coordinated under the Integrated Disease Surveillance Project (IDSP), the decentralised state-based disease surveillance programme established in 2004 with the National Centre for Disease Control (NCDC) as its nodal agency.

The IDSP is operationalised by state governments through a strong network of health workers, who collect and compile patient data to monitor, detect and respond to epidemics. This is largely done manually. Similarly, the Aarogya Setu mobile app is currently at the forefront of government responses in identifying clusters and hotspots.

Also Read: Will Bluetooth and Aarogya Setu Allow Us to Safely Exit the COVID-19 Lockdown?

An efficacious government surveillance programme requires collection and processing of large scale personal data, including sensitive health and location data. This has raised crucial concerns relating to protection and privacy of the personal data so collected and the purpose for which it would be used after the pandemic is over. Recognising that data privacy is a part of right to life and a fundamental human right, the Supreme Court has already comprehensively enunciated the principles of informational privacy and data protection in its celebrated judgment of K.S. Puttaswamy vs Union of India, which has also found articulation in the Personal Data Protection Bill, 2019 (PDP Bill) currently under discussion in a joint parliamentary committee of which the first author of this article is a member.

Some of these principles include reasonable processing of data, purpose limitation, collection limitation, lawful processing, storage limitation, data quality and accountability along with crucial rights of persons whose data is being collected. One such right is the right to be forgotten. Once enacted, collection and processing of the personal data – both by government, corporate and non-government organizations – will be subject to the provisions of this PDP Bill.

Two questions then arise for consideration. Firstly, what measures should be taken to protect the personal data of citizens until the PDP Bill is enacted as law? And secondly, is there a need to enact a separate umbrella surveillance law or make separate sectoral laws?

It is important to note that both the IDSP and Aarogya Setu are currently operating in a legislative void. There is no overarching surveillance law either, even in the matter of national security where the protocols for data collection and surveillance have been laid out merely in executive orders. A protocol for Aarogya Setu was recently released by the Ministry of Electronics and Information Technology, but the same does not provide for a legislative foundation.

On the one hand, the protection of personal data has been recognised as a fundamental right, while on the other, there is an absence of law to effectively outline the state purpose in collecting such data and enforce, limit and balance the rights of citizens against the larger public interests. The currently used Epidemic Disease Act, 1897 or the Disaster Management Act, 2005 by the government does not address these concerns at all. Therefore, a law sanctioning collection of data and requiring the government to follow crucial data protection and surveillance principles is the need of the hour.

data protection personal data

A law sanctioning collection of data and requiring the government to follow crucial data protection and surveillance principles is the need of the hour. Photo: Reuters

One surveillance law or several sectoral laws?

The next question is whether there should be several sectoral laws setting out separate mechanisms of data protection and surveillance principles in each sector or an umbrella surveillance law. The PDP Bill enumerates the principles of data protection, as well as provides for mechanisms to address any violations of its provisions.

For example, the PDP Bill imposes fines on a corporate or person when they fail to comply with certain provisions of the Bill. Similarly, it also provides for an adjudicatory mechanism where the citizens may seek compensation for any ‘harm’ caused to them due to the violation of any provision of the Bill. However, in order to detect and determine breaches in the data protection and processing principles (such as purpose limitation, collection limitation and storage limitation), there must be a clear enunciation of the purpose and use of such personal data within a legislative framework. While an umbrella law may be simpler and easier to frame, it may miss out sector specific nuances to achieve the stated state purpose.

Also Read: 1.3 Billion People. One Virus. How Much Privacy?

For example, collection of data and its use to achieve the state objectives would be different in case of the health sector as in case of the current pandemic from that of the security of the nation considerations involving issues of terrorism and counterfeit currency. The surveillance requirements in both cases would understandably be different. It can be carried out best by the industry-specific regulator or the appropriate ministry having a detailed understanding and knowledge of the sector. Only such a specialised approach can lead to an effective formulation of the purpose, use and necessity of personal data for specific purposes and an effective adjudication of the violation of data principles under the PDP Bill.

Amar Patnaik is a Rajya Sabha MP from Odisha. Views are personal. Nikhil Pratap is a practising advocate.

Rajasthan: COVID-19 Screening Adds to Panic Among Migrant Workers in Rural Areas

Many migrant workers are finding ways to avoid the screening for COVID-19 because they are afraid of being sent to isolation wards, away from their families. 

Jaipur: The hastily announced national lockdown last week caused an exodus of migrants from various cities and towns as lakhs of migrant workers took the roads overnight in a panic, risking police action and death in the face of no earnings, to get home to their villages. Now, as they reach their states, the mandatory COVID-19 screening at states borders is aggravating the panic among workers and their families.

Many are afraid of being sent to isolation wards, away from their families.

In Rajasthan’s tribal belt of Dungarpur, about 1.5 lakh migrant workers have reportedly returned from Maharashtra and Gujarat over the past ten days. Medical staff from Dungarpur, deployed at the Rajasthan-Gujarat border in Ratanpur, have been tasked to ask the migrant workers to disclose their name, address, phone number, date of arrival, and if they have cough, cold, fever or headache – before they are permitted to enter their villages.

Screening in rural areas is mostly restricted to noting down contact details of the migrant workers. Photo: The Wire

Locals say many of the migrant workers are misinformed about COVID-19, and are trying to avoid the screening.“Many tribal people don’t have the right information about the coronavirus pandemic. They always handle coughs, colds and fevers on their own and that’s why they are apprehensive about disclosing such details to the doctors,” says Azad, the sarpanch at Biliya village in Sagwara tehsil of Dungarpur. “They are also afraid of being sent to isolation wards, away from their families.”

Azad says that many workers fled to their homes using a shortcut through the jungle to escape the screening at the border.

In Dungarpur, three positive cases of COVID-19 have been reported so far. A 38-year-old migrant worker who was working in Indore had returned to his home in Dungarpur along with his 8-year-old son after the national lockdown was imposed. Both tested positive. Later, his 65-year-old father also tested positive.

A migrant worker in Dungarpur shows the stamp on his hand that is meant to indicate that he has been tested for coronavirus. Photo: The Wire

Despite this, the number of samples being tested in the region is marginal. As per the details of tests conducted by the Rajasthan health department, only 331 samples have been tested at Dungarpur till date even though the number of migrant workers who have returned to the area stands at 1.5 lakh. The samples collected from Dungarpur are being sent to Udaipur for testing.

Locals pointed out that the screening is restricted only to noting migrant workers’ contact details and putting a stamp.

“The doctors keep telling us to ‘maintain distance’ when we are near them as if we have some disease. They just ask our name, village name, age, where we worked and phone number. Then, they put on a stamp saying that it is a proof that we are being tested for COVID-19 and that we should now remain in our houses,” said Mahendra, a migrant worker who returned to his village in Dungarpur from Ahmedabad.

Even the medical staff in Dungarpur admit that at this moment, they are only gathering contact details and advising people to stay quarantined in their homes.

“We go to each house in our area and check if anyone has symptoms of fever, cold or cough. If they show any of these symptoms, we ask them to go to the primary health care centre (PHC) and take antibiotics,” says Chanda, an ANM in Dungarpur. “We also put a seal on their hands and ask them to stay at their homes for at least 10 days.”

Locals also say that the medical staff working on the ground is itself not very well-informed. “The ASHAs working in our areas are hardly metric-pass, they themselves have not much knowledge about the pandemic. All that they do is ask for details and symptoms, without telling the migrant workers the necessity for doing so. This adds to the confusion and panic,” Kanti Bhai, a social worker in Dungarpur told The Wire.

Also read: ICMR Study Suggests Its Testing Strategy Was Flawed, Airport Screening a Miss

He said that that the police force has also not been deployed in rural areas to maintain the lockdown. “Our people here are not educated enough to understand the gravity of the situation. The workers who have returned homes are meeting their neighbours and relatives in the village. Social distancing is not practiced in our area.”

In the absence of safety gear, the medical staff in Dungarpur is apprehensive going out in the field to screen those returning for COVID-19. Because of this, they have not able to check many among those who have recently reached the villages.

“The medical staff, the ASHAa and ANMs are not quite comfortable in handling the screening without safety gears. So, the screening is restricted to only noting down their contact details and the symptoms as disclosed by the people,” Vinita Parmar, doctors at the Dungarpur primary healthcare centre told The Wire.

Also read: Coronavirus: Government Drops First Hint of Community Transmission in India

On illiteracy being a major challenge at the moment in rural areas, she says, “While screening in Dungarpur, we came across a man who had symptoms of COVID-19. We referred him to the PHC. When we took him to the isolation ward, he literally ran away from there because he couldn’t understand why we were separating him from his family. The next day, we again went to his house and explained to him politely why isolation is necessary and admitted him to the ward.”

The Bhartiya Tribal Party (BTP), a political party in the region that sprung into existence this past assembly election, has been working tirelessly to spread awareness about the pandemic among the tribal population of Dungarpur. “Our volunteers move about in villages with a loudspeaker to put out basic information about COVID-19, like its symptoms, how it spreads and the importance of getting tested,” Pavan, a BTP member told The Wire.

Meanwhile, the Indian Council of Medical Research (ICMR) has also issued an advisory giving out details on testing migrant workers who have reached their villages.

“Migrant workers who have reached their destination will be identified by the district administration and the Integrated Disease Surveillance Programme (IDSP) team will follow them up at their residence. Those found to be suffering from fever shall be further interviewed by the IDSP team for (i) other symptoms suggestive of COVID-19, (ii) history suggestive of contact with a suspect/confirmed case of COVID-19,” reads the advisory.

It further directs that persons qualifying such criteria must be referred to designated COVID-19 hospitals for testing and isolation.