Editorial 1: Schooling in India in times of poor air quality

Context

Considering scientific rationale and the benefits and risks, the functioning of schools needs to be delinked from Graded Response Action Plan measures.

Introduction

In a stark reminder of the COVID-19 pandemic period, schools in Delhi State, in mid-November 2024 — as a part of the Graded Response Action Plan (GRAP) to tackle air pollution, which is triggered when the Air Quality Index (AQI) is “poor” — had been asked to switch from physical to online mode. While other restrictions imposed as a part of GRAP might have an impact on air quality, the decision to switch schools to online mode needs to be examined for its scientific rationale, practicability, and benefits and risks.

• Harmful effects of poor air quality: Poor air quality in many north Indian States is harmful for any age group and not just children.
  • The harmful health effects of poor air quality are on a continuum from the moment the AQI crosses the normal range.
  • Children (and everyone in any age group) should be protected from poor air quality the moment the AQI crosses 50, which is considered ‘good’ air quality by Indian norms.
• AQI standards and frequency of ‘Good’ air quality: There are only a few days in a year when the AQI is within acceptable limits.
  • In 2024, till now, there has not been even a single day with ‘good’ air quality in Delhi.
  • There was just one such ‘good’ air quality day in 2023.
  • It is naive to believe that an AQI that is more than 400 (classified as ‘severe’ or ‘severe plus’) is harmful and anything below this is not.
  • This arbitrary and high cutoff does not help except inadvertently normalising the harmful health effects of air quality that is in the range of AQI 51 to 399.
• Indoor air quality and disadvantages for children: Most children in Delhi or other parts of the country are likely to have the same air quality inside their homes or in their schools.
  • For some underprivileged children, air quality in the classroom might be better than at home as many schools have air purifiers.
  • The idea of having online classes due to poor AQI puts all children at an additional disadvantage of learning loss and nutritional loss (as many children get mid-day meals in schools), while there is no respite from the health impact.

Limitations of Online Classes

• It is widely known that online classes are not a replacement for school-based learning.
• The only beneficiaries here are EdTech platforms and Apps.
• Younger children are not supposed to have exposure to screen time.
• When they are forced to attend online classes, they are being exposed to more harmful behaviour than receiving any possible or perceived benefit.

Importance of Keeping Schools Open

• In the three years of the COVID-19 pandemic, all of us have learnt that schools are not the places where children read only books; there is life learning.
• The focus has to be on keeping schools functional and ensuring learning continuity.
• There was an article related to this, in this daily, by one of the writers: “The pathology of school closure in India”, February 16, 2022.

The oversold idea of face masks

• Advisories on mace Masks: Poor air quality nearly always brings up the issue of face masks.
  • Even before GRAP stages III and IV recommended the suspension of physical classes, a few schools sent out advisories to parents that children should wear face masks in order to attend schools.
  • Though it was argued that these advisories were to provide guidance, such advisories from schools became an ‘informal mandate’ for children and parents.
• Lack of scientific backing for uniform mask mandates: Such a uniform advisory for all children to wear a face mask is not fully backed by science.
• During the COVID-19 pandemic:
  • Masks were not recommended for children younger than five years for various scientific reasons and empirical data.
  • For those between six to 11 years, masks were advised (and not mandated).
  • There is no rationale for anyone to wear face masks if the set-up has air purifiers.
• Need for a nuanced approach: The face mask-wearing guidance for children has to have a nuanced and personalised approach.
  • Schools should refrain from issuing such advisories.
  • Such advisories should come only after guidance from medical experts.

Adopt a science-based approach

• First, schools should not be made to switch to online classes: No matter what the level of AQI is. The focus should be on keeping the school functional and ensuring learning continuity.
  • This could be done with some mitigants such as completely halting all outdoor activities in schools when the AQI is poor.
  • Everyone should take appropriate personal protective measures, such as the use of purifiers and face masks, taking into account recommendations by age, and pre-existing health issues.
  • Those who have any pre-existing respiratory health issue are likely to benefit more from mask wearing, specifically in a polluted and open space.
• Second, to attend school, there is no need for a uniform directive for mask wearing: Schools are not the source of pollution. Arguably, air quality in schools is similar to the homes of children.
  • Therefore, it does not make any sense to do anything differently in school than what is done at home.
  • If children and parents wear a face mask at home, they can wear it at school as well.
  • Else, no additional mandatory mask wearing measure is needed.
  • There is a need to remember that face masks can also have negative effects such as causing a skin allergy and other discomforts.
  • So, one should keep in mind the benefits and the associated risks.
  • Also, except for medical recommendations, children younger than 12 years should not be made to wear N95 masks.
  • During periods of severe or above AQI, children who have pre-existing health issues or any other parents who wish to keep their children at home, should be given an ‘opt-out’ option from physical classes, and the rest of the children should have the opportunity for learning continuity.
• Third, in schools or other settings which have functional air purifiers: Mask wearing is not going to provide any additional advantage.
  • For such settings, i.e., schools, ensuring that the classroom doors and windows are closed properly and switching on air purifiers at least an hour before children arrive would ensure ‘good’ quality air.
• Fourth, ‘online schooling’ is an oxymoron: It is not school if teaching is online. The option of hybrid classes should not be interpreted conveniently by schools.
  • Also, other than air quality, there are other reasons such as foggy or cold winter days, which many schools exercise as a reason for switching to online or hybrid classes.
  • These should be actively discouraged and teaching should be in physical mode for all parents, who are willing.
  • In fact, it is problematic that school classes are often referred to as ‘offline’ or ‘online’, placing electronic devices at the centre of teaching and learning.
  • We need to break this mode of thinking.
  • Therefore, in future, if and when the government or any authority fails children by passing an order to switch to online classes, the management in every school needs to come up with innovative approaches to ensure that learning is not in front of a mobile or computer screen.
• Fifth, poor air quality is a reminder: Anyone who has pre-existing health or respiratory conditions should take better care of their health.
  • This means having a routine checkup and a regular follow-up visit with health-care providers.
  • Preventive interventions such as annual influenza vaccination or age-appropriate recommended vaccines like pneumococcal, measles, Haemophilus influenzae Type b (Hib) are administered to those who need it.

Policy must be people-centric

• From a larger social angle, most of the actions recommended as a part of GRAP, adversely and disproportionately, impact the poor and the vulnerable in terms of wages (for the poor and the marginalised) as well as learning and nutrition (for children) losses.
• This is a reminder that whatever is done in the name of the policy should have a people-centric and pro-poor focus. Air quality and school functioning need a nuanced approach.
• India had one of the longest closures of schools during the COVID-19 period and we need to learn from those mistakes. There was another article on this, in this daily, by one of the writers: “Building back to avert a learning catastrophe”, April 28, 2022.

Conclusion

Schools are not the source of air pollution. Rather, there is far greater loss than benefit from school closure. While there are valid reasons for implementing other measures under GRAP to improve the AQI, closing schools for physical classes makes the least sense. It has happened for the last eight years, but now is the time that school functioning is delinked from GRAP measures. Nelson Mandela had said, “There can be no keener revelation of a society’s soul than the way in which it treats its children.” When it comes to handling air quality and the functioning of schools, Indian States and society seem to be failing in their responsibility and their duties.

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Editorial 2: Ban this carcinogenic ‘heart-burn’ drug

Context

The continued manufacture and sale of Ranitidine, the acid reflux treatment drug, in India must stop; government inaction is jeopardising Indian lives

Introduction

Last month, the multinational pharmaceutical company, GSK announced a record settlement of $2.2 billion in the United States in order to settle multiple lawsuits regarding one of its best selling drugs to treat “acid reflux”– Zantac ®, containing the active ingredient Ranitidine, after it was revealed that the drug contained high amounts of a cancer causing carcinogen called N-nitrosodimethylamine (NDMA).

• Valisure’s festing Findings: According to Valisure, the American pharmacy which first raised the issue, testing of various brands of Ranitidine in its labs found NDMA in excess of 3,000,000 nanograms in some samples; the acceptable limit in the U.S. was 96 nanograms.
  • Like all carcinogens, high exposure to NDMA can cause cancer.
• NDMA Issue not specific to GSK: The high amounts of NDMA have been attributed to stability issues with the molecule, which means that it is not a GSK-specific problem.
  • Any company manufacturing Ranitidine will face the same issue.
• Regulatory actions: The United States Food and Drug Administration (USFDA) and the European Medical Agency (EMA) stopped the sale of the various brands of Ranitidine in their jurisdictions as far back as 2020.
  • GSK itself informed stock exchanges in India, in 2020, that it was withdrawing all Ranitidine products in India.
• India’s Ministry of Health’s inaction: Characteristically, India’s Ministry of Health has taken no steps to stop other pharmaceutical companies from continuing to manufacture and sell Ranitidine.

A widely used pharma drug

• Government’s Inaction on Ranitidine sale in India: Back in 2021, after reports in the Indian press pointed out how Ranitidine was still being sold in India, there were some murmurs from the government indicating that it was “looking into” the issue.
  • However, there has been no action from the government since then.
• Key Questions for the government: First Question: Why did the Indian regulatory apparatus never detect/respond to similar levels of impurities in Ranitidine, which is widely consumed in India?
  • Second Question: Why has the government not acted over the last five years in a similar vein as its counterparts in the West to stop the sale of Ranitidine in India, especially when there are enough substitutes like famotidine, cimetidine, esomeprazole, lansoprazole, or omeprazole that also treat “gastroesophageal reflux” (the medical phrase for “acidity”)?
• Need for identifying responsible institutions: To answer these questions, it is first important to identify the key institutions within government responsible for different stages of regulating generic drugs.

The chain of standards setting

• Indian Pharmacopeia Commission (IPC) and Its Role: The task of setting standards, including acceptable limits of impurities and analytical methods for testing generic drugs for such impurities lies with the Indian Pharmacopeia Commission (IPC), an autonomous institution under the Ministry of Health and chaired by the Secretary of Health.
  • In addition to publishing the Indian Pharmacopeia, which lays out standards (including limits for impurities) and testing protocols for different drugs, the IPC is also required to manufacture and supply “reference standards” and “impurity standards” against which drugs such as Ranitidine can be tested in quality control laboratories in the public and private sector.
• Ensuring Compliance with IPC Standards: The task of ensuring that drug manufacturers comply with the quality standards laid down by the IPC lies
  • first, with the State drug controllers responsible for issuing manufacturing licences for such drugs and,
  • second, with drug inspectors of the States and the Centre who randomly draw samples of drugs from the market for testing by analysts in government laboratories against the standards laid down by the IPC.
  • Drugs that fail to comply with the IPC’s standards are deemed to be “not of standard quality.”

Key Questions for the IPC

• With this background, the key questions to ask of the IPC are why did it not detect the NDMA issue with Ranitidine and what exactly has it done since 2020 to lay down permissible standards for NDMA in Ranitidine, along with the testing protocols.
• We cannot answer these questions because we have no access to copies of the latest version of the Indian Pharmacopeia.
  • It costs ₹50,000 to purchase the most recent version of the Indian Pharmacopeia. Ideally it should be made available for free given that it contains binding legal standards and is very important from a public health perspective.
• Once the IPC sets the permissible limits for NDMA in Ranitidine, ideally, the manufacturers of Ranitidine who cannot comply with the impurity standards laid down by the IPC either stop manufacturing Ranitidine or drug inspectors prosecute these manufacturers for manufacturing “not of standard quality” drugs.

Conclusion

Separate and apart from the role of the IPC in setting standards, there is the question of who in government is responsible for acting to prohibit a drug from being sold in the market once a public health concern has been flagged anywhere in the world. Under Section 26A of The Drugs and Cosmetics Act, 1940 only the central government, or more precisely, the Drug Regulation Section within the Ministry of Health has the power to prohibit the manufacture and sale of drugs in the country. This section in the Ministry lacks the technical competence to perform its job since it is typically headed by a faceless Joint Secretary from the civil services who knows little about the pharmaceutical industry or pharmacology. Perhaps it is now time, after a $2.2 billion settlement, for the Ministry of Health to swing into action and issue an order under Section 26A prohibiting with immediate effect, the continued manufacture and sale of Ranitidine in the country.