Relief for online pharmacies as HC stays ban

Agencies
January 2, 2019

Chennai, Jan 2: The Madras High Court Wednesday stayed until further orders a single judge's order banning online sale of medicines, saying patients would be affected if it was prohibited all of a sudden.

A division bench of Justice M Sathyanarayanan and Justice P Rajamanickam granted the interim stay, allowing miscellaneous petitions filed by a batch of traders involved in online sale of medicines.

It had on December 21 reserved orders on the plea.

Justice Pushpa Sathyanarayana had in her December 17 order banned online sale of medicines till the Union Health Ministry and the Central Drugs Standard Control Organisation notified the proposed Drugs and Cosmetics Amendment Rules, 2018 in the gazette at the earliest by January 31.

The order was passed on a petition by the Tamil Nadu Chemists and Druggists Association (TNCDA).

Challenging it, petitioners, including Netmeds Marketplace Ltd, filed appeals along with the miscellaneous petitions, seeking a stay on the single judge's order.

The appellants submitted that the judge had failed to see that their online business model involves licences under the Drugs and Cosmetics Act, and periodic forms and inspections by drug inspectors and statutory authorities were being carried out.

The central government itself, as the rule-making party, categorically held that door-to-door vending of drugs by shipping, mail, hand delivery etc., was not prohibited under the Act, they further submitted.

In its interim order, the bench said online sale was going on for quite some time.

"If all of a sudden, it is stopped till the amendments are notified, it would definitely create grave hardship, inconvenience and health issues to the concerned patients or persons, who order medicines through online platform," it said.

Sale through online platform was a developing concept and has been picking up, the judges noted, adding that handling the medicines required great care as it dealt with human lives.

It was also the categorical stand and assurance of the appellants that no irregularity or illegality would be allowed to take place while selling or dispensing medicines through online platform, they added.

The bench said the authorities constituted under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 were competent to initiate appropriate action in the event of any violation of the provisions.

Hence, the court was of the considered view that the relevant portion of the impugned order of the single judge barring online sale of medicines till the draft rules were framed by the Centre required to be stayed till further orders, it said.

The bench adjourned the appeals for final hearing on January 24.

According to the TNCDA, though online shopping might be convenient to consumers, purchasing medicines through the medium could be risky as fake, expired, and unapproved drugs or unsafe products dangerous to patients might be sold.

The association had contended that medicines are not simple items of commerce but an essential component of patients' health, and drugs are to be provided under the direct supervision of a qualified pharmacist for patients' benefit.

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Agencies
June 27,2020

After admitting that the world may have a COVID-19 vaccine within one year or even a few months earlier, the World Health Organisation (WHO) on Friday said that UK-based AstraZeneca is leading the vaccine race while US-based pharmaceutical major Moderna is not far behind.

WHO Chief Scientist Soumya Swaminathan stated that the AstraZeneca's coronavirus vaccine candidate is the most advanced vaccine currently in terms of development.

"I think AstraZeneca certainly has a more global scope at the moment in terms of where they are doing and planning their vaccine trials," she told the media.

AstraZeneca's Covid-19 vaccine candidate developed by researchers from the Oxford University will likely provide protection against the disease for one year, the British drug maker's CEO told Belgian radio station Bel RTL this month.

The Oxford University last month announced the start of a Phase II/III UK trial of the vaccine, named AZD1222 (formerly known as ChAdOx1 nCoV-19), in about 10,000 adult volunteers. Other late-stage trials are due to begin in a number of countries.

Last week, Swaminathan had said that nearly 2 billion doses of the COVID-19 vaccine would be ready by the end of next year.

Addressing the media from Geneva, she said that "at the moment, we do not have a proven vaccine but if we are lucky, there will be one or two successful candidates before the end of this year" and 2 billion doses by the end of next year.

Scientists predict that the world may have a COVID-19 vaccine within one year or even a few months earlier, said the Director-General of the World Health Organization even as he underlined the importance of global cooperation to develop, manufacture and distribute the vaccines.

However, making the vaccine available and distributing it to all will be a challenge and will require political will, WHO chief Tedros Adhanom Ghebreyesus said on Thursday during a meeting with the European Parliament's Committee for Environment, Public Health and Food Safety.

One option would be to give the vaccine only to those who are most vulnerable to the virus.

There are currently over 100 COVID-19 vaccine candidates in various stages of development.

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Agencies
May 25,2020

Singapore, May 25: COVID-19 patients are no longer infectious after 11 days of getting sick even though some may still test positive, according to a new study by infectious disease experts in Singapore.

A positive test "does not equate to infectiousness or viable virus," a joint research paper by Singapore's National Centre for Infectious Diseases and the Academy of Medicine, Singapore said. The virus "could not be isolated or cultured after day 11 of illness."

The paper was based on a study of 73 patents in the city-state.

The latest findings may have implications on the country's patient discharge policy. The discharge criteria is currently based on negative test results rather than infectiousness.

Singapore's strategy on managing COVID-19 patients is guided by the latest local and international clinical scientific evidence, and the Ministry of Health will evaluate if the latest evidence can be incorporated into its patient clinical management plan, according to a report by the Straits Times.

So far, 13,882, or about 45% of the total 31,068 Covid-19 patients in Singapore have been discharged from hospitals and community facilities. Singapore reported 642 new Covid-19 cases as of noon on Saturday.

The government has been actively screening pre-school staff as it prepares to reopen pre-schools from June 2. On Friday, two pre-school employees tested positive for the novel coronavirus, bringing the total number of confirmed cases among pre-school staff to seven, according to the Ministry of Health.

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Agencies
June 30,2020

Between 30-40 per cent of deaths from studies in intensive care units from different countries are people with diabetes, said Paul Zimmet, Professor of Diabetes, Monash University, Australia.

Zimmet, who is President International Diabetes Federation, added that the actual mechanism as to why COVID-19 may cause diabetes is as yet unknown, however, several possibilities exist. "COVID-19 is a very destructive and cunning virus and causes terrible damage to tissues including the lungs and pancreas," said Zimmet. Below are excerpts from an exclusive chat with IANS.

Why do you say Diabetes is dynamite if a person has been infected with COVID-19?

There have been many deaths in many countries, e.g. Italy, China, the UK and US among people with diabetes after infection with COVID-19 (SARS-Cov-2).

The mortality tends to be mainly in older Type 2 diabetics. Between 30-40 per cent of deaths from studies in intensive care units from different countries are people with diabetes. This outcome and other complications from the virus, particularly pneumonia, are more likely in people with diabetes which is poorly controlled with high blood sugars (poor metabolic control).

Diabetes is often associated with other chronic conditions, including obesity, hypertension and heart disease compounding the risk. These latter conditions all convey higher risk to COVID-19 infections.

ACE-2, which binds to SARS-Cov-2 and allows the virus to enter human cells is also located in organs and tissues involved in glucose metabolism. Is there solid evidence that virus after entering tissues may cause multiple and complex impairment of glucose metabolism?

The actual mechanism as to why COVID-19 may cause diabetes is as yet unknown.

However, several possibilities exist. Firstly, COVID-19 is a very destructive and cunning virus and causes terrible damage to tissues, including the lungs and pancreas.

A new study just published showed that in miniature lab-grown pancreas, and other cells such as liver, made using human stem cells, COVID-19 caused destruction of the pancreas beta cells that produce insulin.

It is possible that the virus causes disruption of the cells by disrupting cellular metabolism. This is possibly the way it brings about new-onset diabetes. ACE-2 exists in high concentration in the lung as this also explains the terrible lung side effects of COVID-19 infections.

Can COVID-19 lead to a new mechanism of diabetes? Probably a new form of diabetes or a new form of disease?

The COVID-19 virus has only been with us for about 5 months and there is a huge amount that we still must learn about its cunning and devastating ways. The purpose of the Global COVIDIAB Diabetes Registry, a joint initiative of Monash University in Australia, and King’s College London is to gain a much better understanding of how common is the appearance of COVID-19 related diabetes, what form does it take be it type 1 or type 2 or a new form, and how common are the complications that we already know e.g. diabetic keto-acidosis, hyperosmolar coma and high insulin requirements are causing high rates of ill health and mortality worldwide. The knowledge gained will aid our understanding for developing strategies to prevent and treat this terrible virus that has caused destruction globally.

Diabetes is one of the most prevalent chronic diseases in India. According to a recent study, sugar levels of diabetic persons increased by 20 per cent during nationwide lockdown in India to contain COVID-19 outbreak. Even after lockdown was lifted, many people are confined within their home. Do you think lack of physical activity will create more problems for diabetics?

My own major research has been on studying populations with high rates of diabetes, including ethnic Indian communities including India, Mauritius, and Fiji so I am very well aware of this. It is now well established that along with diabetes, that associated poor metabolic control of their diabetes places these people at the highest risk for COVID infection and its devastating complications and the associated morbidity and mortality. And these communities have high prevalence of heart disease as well.

Lockdown not only has deleterious effects on metabolic control of the diabetes through reduced opportunities for exercise to be protective serious consequences of SARS-CoV-2 infection, lockdown usually results in disruption of the regular medical care and the regular monitoring of metabolic control. This may also be partly due to the stress and poor compliance, or inability to afford their medications such as insulin. It may also be compounded by inability to access the care during the pandemic. Nevertheless, we now know that poor metabolic control heightens their risk as described above.

You have said diabetes is itself a pandemic just like Covid-19, and the two pandemics could be clashing. How could governments address this problem?

These are “The Times of COVID-19”. Most nations of the world were totally unprepared for a pandemic of this magnitude. They underestimated its potential impact and the destructive nature of the viral infection. This should prompt all countries to upgrade their guidelines to take into account the lessons learnt on infection control including training of staff specialising in infectious diseases and improved public education and taking their communities into their confidence about the terrible nature of COVID-19. The risks of COVID-19 infection need a much higher priority in the general community, particularly for people with chronic conditions such as diabetes, obesity, and cardiac conditions.

Governments are faced with chronic diseases (NCDs) like diabetes and communicable diseases (CDs) like viral and enteric diseases and TB. In general WHO gives the highest priority to communicable diseases and much less attention and funding to chronic diseases like diabetes (I was an adviser to WHO for many years (about 30) on diabetes and obesity and it was very frustrating to deal with this situation).

This attitude to diabetes, for example, has a flow down effect so that diabetes funding in countries by governments, rich and poor, suffered and was insufficient.

So now we have a COVID-19 pandemic and who are those at highest risk, yes people with diabetes and other NCDs, it is very important that now the two, Diabetes and COVID-19 are clashing face-to-face. This is a major issue that WHO and national governments have to face with equal priority’

Stressed people suffering from diabetes run a greater risk of poor blood glucose levels, what do you suggest to these people?

As mentioned in the answer above, stress is an important factor in upsetting the blood sugar (metabolic) control of diabetes. Additive to this is poor compliance with medications and diet. These and potential associated comorbidities due to other chronic conditions are part of the dynamic dynamite mixture.

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