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 17,2020

Leading physicians are celebrating a small dose of good news that arrived Tuesday about dexamethasone, a cheap and widely used steroid shown to be able to save lives among COVID-19 patients, but also cautioning against releasing study results by press release during a global health emergency, like in the case of the latest dexamethasone study by University of Oxford.

"It will be great news if dexamethasone, a cheap steroid, really does cut deaths by one-third in ventilated patients with COVID19, but after all the retractions and walk backs, it is unacceptable to tout study results by press release without releasing the paper", Atul Gawande, surgeon and CEO of Haven Healthcare, tweeted.

"Bottom line is, good news," Dr. Fauci, America's foremost infectious diseases expert told a US newswire on Tuesday, soon after the dexamethasone results were announced in the UK.

Fauci, who has long championed the therapeutics-first view said that dexamethasone is a "significant improvement" in the available therapeutic options currently available.

On Medical Twitter and Facebook, doctors broadly agree that dexamethasone use aligns well with the way COVID19 attacks the body's immune system. Fauci said the results in the Oxford study make "perfect sense" in that context.

"We should see the number of people who actually survive go up, if the study holds up," virologist and epidemiologist Dr. Joseph Fair told a television network.

Global coronavirus cases crossed 8 million on Tuesday. In the US, Texas and Florida are facing a new wave of cases after lifting lockdown orders earlier than medical experts recommended. Amidst the relentless graph upwards, the dexamethasone study results injected hope for better survival rates among those most seriously ill.

World Health Organization chief scientist Soumya Swaminathan welcomed the results from the randomised control trial.

Dr Eugene Gu, Founder and CEO of CoolQuit tweeted that he is "genuinely impressed" with the UK dexamethasone trial. This may be a "game changer", he wrote.

"There's no conflict of interest as dexamethasone is a generic steroid. The mechanism of action makes sense because steroids can reduce cytokine storms and overactive immune systems that makes COVID-19 so deadly. The number needed to treat is 8 ventilated patients which is great."

The Oxford study found that dexamethasone reduced deaths by 35 percent in patients who needed treatment with breathing machines and by 20 percent in those only needing supplemental oxygen. Dexamethasone was one of 5 drugs studied in a large clinical trial in the United Kingdom named RECOVERY, short for Randomised Evaluation of COVID-19 Therapy.

Peter Horby, chief investigator of the University of Oxford clinical trial, said dexamethasone is the first drug to be shown to improve survival in COVID-19. Details of the study have not been released. The trial organisers said they made their announcement via a news release because of "the public health importance of these results." According to Horby's public comments, there was a lot of initial resistance to studying steroids.

During the study, 2,104 patients were randomly selected to be given 6 milligrams of dexamethasone once a day (either by mouth or by intravenous injection) for 10 days. That group was compared with 4,321 patients who received the usual care alone.

Researchers estimated that dexamethasone would prevent one death for every eight patients treated while on ventilators and one for every 25 patients on extra oxygen alone.

UK experts have called the study results a breakthrough in the fight against the virus. The researchers have promised they would publish the results soon.

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News Network
February 12,2020

Washington, Feb 12: People who are optimistic may contribute to the health of their partners, staving off the risk factors leading to Alzheimer's disease, dementia and cognitive decline as they grow old together, according to a study.

The research, published in the Journal of Personality, followed nearly 4,500 heterosexual couples from the US Health and Retirement Study for up to eight years.

The researchers found a potential link between being married to an optimistic person and preventing the onset of cognitive decline, due to a healthier environment at home.

"We spend a lot of time with our partners.They might encourage us to exercise, eat healthier or remind us to take our medicine," said William Chopik, an assistant professor at the Michigan State University in the US.

"When your partner is optimistic and healthy, it can translate to similar outcomes in your own life. You actually do experience a rosier future by living longer and staving off cognitive illnesses," Chopik said.

An optimistic partner may encourage eating healthy foods, or working out together to develop healthier lifestyles, the researchers said.

For example, if a person quits smoking or starts exercising, their partner is close to following suit, they said.

"We found that when you look at the risk factors for what predicts things like Alzheimer's disease or dementia, a lot of them are things like living a healthy lifestyle," Chopik said.

"Maintaining a healthy weight and physical activity are large predictors.There are some physiological markers as well. It looks like people who are married to optimists tend to score better on all of those metrics," he said.

The researchers said there is a sense where optimists lead by example, and their partners follow their lead.

They also suggest that when couples recall shared experiences together, richer details from the memories emerge.

Chopik noted while there is a heritable component to optimism, there is some evidence to suggest that it's a trainable quality.

"There are studies that show people have the power to change their personalities, as long as they engage in things that make them change," Chopik said.

"Part of it is wanting to change. There are also intervention programs that suggest you can build up optimism," he added.

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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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